Haleon
FDA Approved Drugs

Haleon

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

OTC Discontinued
  • Total Records 42
  • Latest Approval Date Feb 28, 2020
  • Data Source FDA
  • First Approval Date May 18, 1984
All
42
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Discontinued
4
View
OTC
38
View
Company Overview

Company

Haleon

Country

United Kingdom

Website

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Company Snapshot

Haleon

Building 5, First Floor the Heights Weybridge Surrey KT13 0NY

United Kingdom

www.haleon.com/ View on Map
FDA Approved Drug Records ( 42 records )
2000
25 Jul
OTC Application: 20941

Drug Name

ABREVA

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2000-07-25

20941 / 1

Active Ingredient

DOCOSANOL

Application Number

20941

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2000-07-25

Regulatory Status

OTC

1984
18 May
OTC Application: 18989

Drug Name

ADVIL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1984-05-18

18989 / 1

Active Ingredient

IBUPROFEN

Application Number

18989

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1984-05-18

Regulatory Status

OTC

2012
12 Jun
OTC Application: 201803

Drug Name

ADVIL

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-06-12

201803 / 1

Active Ingredient

IBUPROFEN SODIUM

Application Number

201803

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-06-12

Regulatory Status

OTC

2011
21 Dec
OTC Application: 22113

Drug Name

ADVIL ALLERGY AND CONGESTION RELIEF

Product Number

1

Dosage Form

-

Strength

4MG;200MG;10MG

Approval Date

2011-12-21

22113 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

Application Number

22113

Product Number

1

Dosage Form

-

Strength

4MG;200MG;10MG

Approval Date

2011-12-21

Regulatory Status

OTC

2002
19 Dec
OTC Application: 21441

Drug Name

ADVIL ALLERGY SINUS

Product Number

1

Dosage Form

-

Strength

2MG;200MG;30MG

Approval Date

2002-12-19

21441 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21441

Product Number

1

Dosage Form

-

Strength

2MG;200MG;30MG

Approval Date

2002-12-19

Regulatory Status

OTC

1989
19 Sep
OTC Application: 19771

Drug Name

ADVIL COLD AND SINUS

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

1989-09-19

19771 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

19771

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

1989-09-19

Regulatory Status

OTC

2002
30 May
OTC Application: 21374

Drug Name

ADVIL COLD AND SINUS

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Approval Date

2002-05-30

21374 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21374

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Approval Date

2002-05-30

Regulatory Status

OTC

2010
27 May
OTC Application: 22565

Drug Name

ADVIL CONGESTION RELIEF

Product Number

1

Dosage Form

-

Strength

200MG;10MG

Approval Date

2010-05-27

22565 / 1

Active Ingredient

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

Application Number

22565

Product Number

1

Dosage Form

-

Strength

200MG;10MG

Approval Date

2010-05-27

Regulatory Status

OTC

2020
28 Feb
OTC Application: 211733

Drug Name

ADVIL DUAL ACTION WITH ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2020-02-28

211733 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

211733

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2020-02-28

Regulatory Status

OTC

1995
20 Apr
OTC Application: 20402

Drug Name

ADVIL LIQUI-GELS

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

1995-04-20

20402 / 1

Active Ingredient

IBUPROFEN

Application Number

20402

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

1995-04-20

Regulatory Status

OTC

2000
16 Mar
OTC Application: 20402

Drug Name

ADVIL MIGRAINE LIQUI-GELS

Product Number

2

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2000-03-16

20402 / 2

Active Ingredient

IBUPROFEN

Application Number

20402

Product Number

2

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2000-03-16

Regulatory Status

OTC

2017
28 Apr
OTC Application: 22113

Drug Name

ADVIL MULTI-SYMPTOM COLD & FLU

Product Number

2

Dosage Form

-

Strength

4MG;200MG;10MG

Approval Date

2017-04-28

22113 / 2

Active Ingredient

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

Application Number

22113

Product Number

2

Dosage Form

-

Strength

4MG;200MG;10MG

Approval Date

2017-04-28

Regulatory Status

OTC

2005
21 Dec
OTC Application: 21393

Drug Name

ADVIL PM

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2005-12-21

21393 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Application Number

21393

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2005-12-21

Regulatory Status

OTC

2005
21 Dec
OTC Application: 21394

Drug Name

ADVIL PM

Product Number

1

Dosage Form

-

Strength

38MG;200MG

Approval Date

2005-12-21

21394 / 1

Active Ingredient

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Application Number

21394

Product Number

1

Dosage Form

-

Strength

38MG;200MG

Approval Date

2005-12-21

Regulatory Status

OTC

2007
07 Feb
OTC Application: 21887

Drug Name

ALLI

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2007-02-07

21887 / 1

Active Ingredient

ORLISTAT

Application Number

21887

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2007-02-07

Regulatory Status

OTC

1996
09 May
OTC Application: 20555

Drug Name

AXID AR

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1996-05-09

20555 / 1

Active Ingredient

NIZATIDINE

Application Number

20555

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1996-05-09

Regulatory Status

OTC

1989
19 Sep
Discontinued Application: 19833

Drug Name

CHILDRENS ADVIL

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1989-09-19

19833 / 2

Active Ingredient

IBUPROFEN

Application Number

19833

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1989-09-19

Regulatory Status

Discontinued

1996
27 Jun
OTC Application: 20589

Drug Name

CHILDRENS ADVIL

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1996-06-27

20589 / 1

Active Ingredient

IBUPROFEN

Application Number

20589

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1996-06-27

Regulatory Status

OTC

1998
18 Dec
OTC Application: 20944

Drug Name

CHILDRENS ADVIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-12-18

20944 / 1

Active Ingredient

IBUPROFEN

Application Number

20944

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1998-12-18

Regulatory Status

OTC

2004
24 Feb
OTC Application: 21587

Drug Name

CHILDRENS ADVIL ALLERGY SINUS

Product Number

1

Dosage Form

-

Strength

1MG/5ML;100MG/5ML;15MG/5ML

Approval Date

2004-02-24

21587 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21587

Product Number

1

Dosage Form

-

Strength

1MG/5ML;100MG/5ML;15MG/5ML

Approval Date

2004-02-24

Regulatory Status

OTC

2002
18 Apr
OTC Application: 21373

Drug Name

CHILDRENS ADVIL COLD

Product Number

1

Dosage Form

-

Strength

100MG/5ML;15MG/5ML

Approval Date

2002-04-18

21373 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21373

Product Number

1

Dosage Form

-

Strength

100MG/5ML;15MG/5ML

Approval Date

2002-04-18

Regulatory Status

OTC

1997
07 Nov
OTC Application: 20589

Drug Name

CHILDRENS ADVIL-FLAVORED

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1997-11-07

20589 / 2

Active Ingredient

IBUPROFEN

Application Number

20589

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

1997-11-07

Regulatory Status

OTC

1998
14 Jan
OTC Application: 20802

Drug Name

EXCEDRIN (MIGRAINE RELIEF)

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

1998-01-14

20802 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Application Number

20802

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

1998-01-14

Regulatory Status

OTC

1994
19 Oct
Discontinued Application: 20121

Drug Name

FLONASE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-10-19

20121 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

20121

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1994-10-19

Regulatory Status

Discontinued

2014
23 Jul
OTC Application: 205434

Drug Name

FLONASE ALLERGY RELIEF

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2014-07-23

205434 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

205434

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2014-07-23

Regulatory Status

OTC

2016
02 Aug
OTC Application: 22051

Drug Name

FLONASE SENSIMIST ALLERGY RELIEF

Product Number

2

Dosage Form

-

Strength

0.0275MG/SPRAY

Approval Date

2016-08-02

22051 / 2

Active Ingredient

FLUTICASONE FUROATE

Application Number

22051

Product Number

2

Dosage Form

-

Strength

0.0275MG/SPRAY

Approval Date

2016-08-02

Regulatory Status

OTC

2000
12 Jan
OTC Application: 20812

Drug Name

INFANTS ADVIL

Product Number

2

Dosage Form

-

Strength

50MG/1.25ML

Approval Date

2000-01-12

20812 / 2

Active Ingredient

IBUPROFEN

Application Number

20812

Product Number

2

Dosage Form

-

Strength

50MG/1.25ML

Approval Date

2000-01-12

Regulatory Status

OTC

1996
13 Dec
OTC Application: 20267

Drug Name

JUNIOR STRENGTH ADVIL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-12-13

20267 / 2

Active Ingredient

IBUPROFEN

Application Number

20267

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-12-13

Regulatory Status

OTC

1998
18 Dec
OTC Application: 20944

Drug Name

JUNIOR STRENGTH ADVIL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1998-12-18

20944 / 2

Active Ingredient

IBUPROFEN

Application Number

20944

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1998-12-18

Regulatory Status

OTC

1996
09 Feb
OTC Application: 18612

Drug Name

NICORETTE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1996-02-09

18612 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

18612

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1996-02-09

Regulatory Status

OTC

2000
25 Sep
OTC Application: 18612

Drug Name

NICORETTE

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-09-25

18612 / 4

Active Ingredient

NICOTINE POLACRILEX

Application Number

18612

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2000-09-25

Regulatory Status

OTC

1996
09 Feb
OTC Application: 20066

Drug Name

NICORETTE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1996-02-09

20066 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

20066

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1996-02-09

Regulatory Status

OTC

2000
25 Sep
OTC Application: 20066

Drug Name

NICORETTE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-09-25

20066 / 4

Active Ingredient

NICOTINE POLACRILEX

Application Number

20066

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2000-09-25

Regulatory Status

OTC

2002
31 Oct
OTC Application: 21330

Drug Name

NICORETTE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-10-31

21330 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

21330

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-10-31

Regulatory Status

OTC

2002
31 Oct
OTC Application: 21330

Drug Name

NICORETTE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-10-31

21330 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

21330

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-10-31

Regulatory Status

OTC

2009
18 May
OTC Application: 22360

Drug Name

NICORETTE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-05-18

22360 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

22360

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-05-18

Regulatory Status

OTC

2009
18 May
OTC Application: 22360

Drug Name

NICORETTE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-05-18

22360 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

22360

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-05-18

Regulatory Status

OTC

1998
23 Dec
OTC Application: 18612

Drug Name

NICORETTE (MINT)

Product Number

3

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1998-12-23

18612 / 3

Active Ingredient

NICOTINE POLACRILEX

Application Number

18612

Product Number

3

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1998-12-23

Regulatory Status

OTC

1998
23 Dec
OTC Application: 20066

Drug Name

NICORETTE (MINT)

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1998-12-23

20066 / 3

Active Ingredient

NICOTINE POLACRILEX

Application Number

20066

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

1998-12-23

Regulatory Status

OTC

1998
30 Jan
Discontinued Application: 20812

Drug Name

PEDIATRIC ADVIL

Product Number

1

Dosage Form

-

Strength

100MG/2.5ML

Approval Date

1998-01-30

20812 / 1

Active Ingredient

IBUPROFEN

Application Number

20812

Product Number

1

Dosage Form

-

Strength

100MG/2.5ML

Approval Date

1998-01-30

Regulatory Status

Discontinued

1992
21 Aug
Discontinued Application: 20925

Drug Name

TAVIST-1

Product Number

1

Dosage Form

-

Strength

1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-08-21

20925 / 1

Active Ingredient

CLEMASTINE FUMARATE

Application Number

20925

Product Number

1

Dosage Form

-

Strength

1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-08-21

Regulatory Status

Discontinued

2007
17 Oct
OTC Application: 22122

Drug Name

VOLTAREN ARTHRITIS PAIN

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2007-10-17

22122 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

22122

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2007-10-17

Regulatory Status

OTC

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Drug Status Breakdown
42 total
  • OTC
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ABREVA

Application Number

20941

Product Number

1

Active Ingredient

DOCOSANOL

Dosage Form

-

Strength

10%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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