Haleon OTC
FDA Approved Drugs
Haleon OTC
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.
- Total Records 38
- Latest Approval Date Feb 28, 2020
- Data Source FDA
- First Approval Date May 18, 1984
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Haleon OTC
Building 5, First Floor the Heights Weybridge Surrey KT13 0NY
United Kingdom
www.haleon.com/ View on MapFDA Approved Drug Records ( 38 records )
Drug Name
ABREVA
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2000-07-25
Active Ingredient
DOCOSANOL
Application Number
20941
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2000-07-25
Regulatory Status
OTC
Drug Name
ADVIL
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1984-05-18
Active Ingredient
IBUPROFEN
Application Number
18989
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1984-05-18
Regulatory Status
OTC
Drug Name
ADVIL
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-06-12
Active Ingredient
IBUPROFEN SODIUM
Application Number
201803
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-06-12
Regulatory Status
OTC
Drug Name
ADVIL ALLERGY AND CONGESTION RELIEF
Product Number
1
Dosage Form
-
Strength
4MG;200MG;10MG
Approval Date
2011-12-21
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
Drug Name
ADVIL ALLERGY SINUS
Product Number
1
Dosage Form
-
Strength
2MG;200MG;30MG
Approval Date
2002-12-19
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
Drug Name
ADVIL COLD AND SINUS
Product Number
1
Dosage Form
-
Strength
200MG;30MG
Approval Date
1989-09-19
Active Ingredient
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
19771
Product Number
1
Dosage Form
-
Strength
200MG;30MG
Approval Date
1989-09-19
Regulatory Status
OTC
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
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
Drug Name
ADVIL CONGESTION RELIEF
Product Number
1
Dosage Form
-
Strength
200MG;10MG
Approval Date
2010-05-27
Active Ingredient
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Application Number
22565
Product Number
1
Dosage Form
-
Strength
200MG;10MG
Approval Date
2010-05-27
Regulatory Status
OTC
Drug Name
ADVIL DUAL ACTION WITH ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
250MG;125MG
Approval Date
2020-02-28
Active Ingredient
ACETAMINOPHEN; IBUPROFEN
Application Number
211733
Product Number
1
Dosage Form
-
Strength
250MG;125MG
Approval Date
2020-02-28
Regulatory Status
OTC
Drug Name
ADVIL LIQUI-GELS
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
1995-04-20
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
Drug Name
ADVIL MIGRAINE LIQUI-GELS
Product Number
2
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2000-03-16
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
Drug Name
ADVIL MULTI-SYMPTOM COLD & FLU
Product Number
2
Dosage Form
-
Strength
4MG;200MG;10MG
Approval Date
2017-04-28
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
Drug Name
ADVIL PM
Product Number
1
Dosage Form
-
Strength
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2005-12-21
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
Drug Name
ADVIL PM
Product Number
1
Dosage Form
-
Strength
38MG;200MG
Approval Date
2005-12-21
Active Ingredient
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Application Number
21394
Product Number
1
Dosage Form
-
Strength
38MG;200MG
Approval Date
2005-12-21
Regulatory Status
OTC
Drug Name
ALLI
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2007-02-07
Active Ingredient
ORLISTAT
Application Number
21887
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2007-02-07
Regulatory Status
OTC
Drug Name
AXID AR
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1996-05-09
Active Ingredient
NIZATIDINE
Application Number
20555
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
1996-05-09
Regulatory Status
OTC
Drug Name
CHILDRENS ADVIL
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
1996-06-27
Active Ingredient
IBUPROFEN
Application Number
20589
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
1996-06-27
Regulatory Status
OTC
Drug Name
CHILDRENS ADVIL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1998-12-18
Active Ingredient
IBUPROFEN
Application Number
20944
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1998-12-18
Regulatory Status
OTC
Drug Name
CHILDRENS ADVIL ALLERGY SINUS
Product Number
1
Dosage Form
-
Strength
1MG/5ML;100MG/5ML;15MG/5ML
Approval Date
2004-02-24
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
Drug Name
CHILDRENS ADVIL COLD
Product Number
1
Dosage Form
-
Strength
100MG/5ML;15MG/5ML
Approval Date
2002-04-18
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
Drug Name
CHILDRENS ADVIL-FLAVORED
Product Number
2
Dosage Form
-
Strength
100MG/5ML
Approval Date
1997-11-07
Active Ingredient
IBUPROFEN
Application Number
20589
Product Number
2
Dosage Form
-
Strength
100MG/5ML
Approval Date
1997-11-07
Regulatory Status
OTC
Drug Name
EXCEDRIN (MIGRAINE RELIEF)
Product Number
1
Dosage Form
-
Strength
250MG;250MG;65MG
Approval Date
1998-01-14
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
Drug Name
FLONASE ALLERGY RELIEF
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2014-07-23
Active Ingredient
FLUTICASONE PROPIONATE
Application Number
205434
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2014-07-23
Regulatory Status
OTC
Drug Name
FLONASE SENSIMIST ALLERGY RELIEF
Product Number
2
Dosage Form
-
Strength
0.0275MG/SPRAY
Approval Date
2016-08-02
Active Ingredient
FLUTICASONE FUROATE
Application Number
22051
Product Number
2
Dosage Form
-
Strength
0.0275MG/SPRAY
Approval Date
2016-08-02
Regulatory Status
OTC
Drug Name
INFANTS ADVIL
Product Number
2
Dosage Form
-
Strength
50MG/1.25ML
Approval Date
2000-01-12
Active Ingredient
IBUPROFEN
Application Number
20812
Product Number
2
Dosage Form
-
Strength
50MG/1.25ML
Approval Date
2000-01-12
Regulatory Status
OTC
Drug Name
JUNIOR STRENGTH ADVIL
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1996-12-13
Active Ingredient
IBUPROFEN
Application Number
20267
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1996-12-13
Regulatory Status
OTC
Drug Name
JUNIOR STRENGTH ADVIL
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1998-12-18
Active Ingredient
IBUPROFEN
Application Number
20944
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1998-12-18
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1996-02-09
Active Ingredient
NICOTINE POLACRILEX
Application Number
18612
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1996-02-09
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
4
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2000-09-25
Active Ingredient
NICOTINE POLACRILEX
Application Number
18612
Product Number
4
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2000-09-25
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1996-02-09
Active Ingredient
NICOTINE POLACRILEX
Application Number
20066
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1996-02-09
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2000-09-25
Active Ingredient
NICOTINE POLACRILEX
Application Number
20066
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2000-09-25
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2002-10-31
Active Ingredient
NICOTINE POLACRILEX
Application Number
21330
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2002-10-31
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2002-10-31
Active Ingredient
NICOTINE POLACRILEX
Application Number
21330
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2002-10-31
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2009-05-18
Active Ingredient
NICOTINE POLACRILEX
Application Number
22360
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2009-05-18
Regulatory Status
OTC
Drug Name
NICORETTE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-05-18
Active Ingredient
NICOTINE POLACRILEX
Application Number
22360
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-05-18
Regulatory Status
OTC
Drug Name
NICORETTE (MINT)
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1998-12-23
Active Ingredient
NICOTINE POLACRILEX
Application Number
18612
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1998-12-23
Regulatory Status
OTC
Drug Name
NICORETTE (MINT)
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1998-12-23
Active Ingredient
NICOTINE POLACRILEX
Application Number
20066
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1998-12-23
Regulatory Status
OTC
Drug Name
VOLTAREN ARTHRITIS PAIN
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2007-10-17
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
38 total- OTC
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ABREVA
Application Number
20941
Product Number
1
Active Ingredient
DOCOSANOL
Dosage Form
-
Strength
10%
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