McNeil Consumer Health
FDA Approved Drugs

McNeil Consumer Health

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.

Discontinued OTC Unclassified
  • Total Records 23
  • Latest Approval Date Jul 03, 1996
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
23
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Unclassified
1
View
Discontinued
21
View
OTC
1
View
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Company

McNeil Consumer Health

Country

Germany

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McNeil Consumer Health

Johnson & Johnson Platz 2 Neuss, 41470

Germany

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FDA Approved Drug Records ( 23 records )
1982
01 Jan
Discontinued Application: 5845

Drug Name

BENADRYL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

5845 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

5845

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5845

Drug Name

BENADRYL

Product Number

4

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

5845 / 4

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

5845

Product Number

4

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5845

Drug Name

BENADRYL

Product Number

7

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

5845 / 7

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

5845

Product Number

7

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6146

Drug Name

BENADRYL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

6146 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

6146

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6146

Drug Name

BENADRYL

Product Number

2

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6146 / 2

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

6146

Product Number

2

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9486

Drug Name

BENADRYL PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

9486 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

9486

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8955

Drug Name

CLISTIN

Product Number

1

Dosage Form

-

Strength

4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8955 / 1

Active Ingredient

CARBINOXAMINE MALEATE

Application Number

8955

Product Number

1

Dosage Form

-

Strength

4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14349

Drug Name

DELFEN

Product Number

2

Dosage Form

-

Strength

12.5%

Approval Date

1982-01-01

14349 / 2

Active Ingredient

NONOXYNOL-9

Application Number

14349

Product Number

2

Dosage Form

-

Strength

12.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
16 Jun
Discontinued Application: 70476

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1986-06-16

70476 / 1

Active Ingredient

IBUPROFEN

Application Number

70476

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1986-06-16

Regulatory Status

Discontinued

1994
30 Mar
OTC Application: 73019

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-03-30

73019 / 1

Active Ingredient

IBUPROFEN

Application Number

73019

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1994-03-30

Regulatory Status

OTC

1986
06 Feb
Discontinued Application: 70475

Drug Name

MEDIPREN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-02-06

70475 / 1

Active Ingredient

IBUPROFEN

Application Number

70475

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-02-06

Regulatory Status

Discontinued

1986
26 Jun
Discontinued Application: 71215

Drug Name

MEDIPREN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-06-26

71215 / 1

Active Ingredient

IBUPROFEN

Application Number

71215

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1986-06-26

Regulatory Status

Discontinued

1986
12 Feb
Discontinued Application: 89193

Drug Name

METHOCARBAMOL AND ASPIRIN

Product Number

1

Dosage Form

-

Strength

325MG;400MG

Approval Date

1986-02-12

89193 / 1

Active Ingredient

ASPIRIN; METHOCARBAMOL

Application Number

89193

Product Number

1

Dosage Form

-

Strength

325MG;400MG

Approval Date

1986-02-12

Regulatory Status

Discontinued

1989
27 Oct
Discontinued Application: 18592

Drug Name

MONISTAT 5

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1989-10-27

18592 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

18592

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1989-10-27

Regulatory Status

Discontinued

-
Unclassified Application: 20968

Drug Name

MONISTAT DUAL- PAK

Product Number

1

Dosage Form

-

Strength

1.2GM;2%

Approval Date

-

20968 / 1

Active Ingredient

MICONAZOLE NITRATE

Application Number

20968

Product Number

1

Dosage Form

-

Strength

1.2GM;2%

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 17463

Drug Name

MOTRIN

Product Number

2

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17463 / 2

Active Ingredient

IBUPROFEN

Application Number

17463

Product Number

2

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17463

Drug Name

MOTRIN

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17463 / 3

Active Ingredient

IBUPROFEN

Application Number

17463

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17463

Drug Name

MOTRIN

Product Number

4

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17463 / 4

Active Ingredient

IBUPROFEN

Application Number

17463

Product Number

4

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
22 May
Discontinued Application: 17463

Drug Name

MOTRIN

Product Number

5

Dosage Form

-

Strength

800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-05-22

17463 / 5

Active Ingredient

IBUPROFEN

Application Number

17463

Product Number

5

Dosage Form

-

Strength

800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-05-22

Regulatory Status

Discontinued

1989
19 Sep
Discontinued Application: 19842

Drug Name

MOTRIN

Product Number

1

Dosage Form

-

Strength

100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-19

19842 / 1

Active Ingredient

IBUPROFEN

Application Number

19842

Product Number

1

Dosage Form

-

Strength

100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-09-19

Regulatory Status

Discontinued

1995
25 May
Discontinued Application: 20476

Drug Name

MOTRIN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1995-05-25

20476 / 1

Active Ingredient

IBUPROFEN

Application Number

20476

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1995-05-25

Regulatory Status

Discontinued

1996
03 Jul
Discontinued Application: 20536

Drug Name

NICOTROL

Product Number

1

Dosage Form

-

Strength

15MG/16HR

Approval Date

1996-07-03

20536 / 1

Active Ingredient

NICOTINE

Application Number

20536

Product Number

1

Dosage Form

-

Strength

15MG/16HR

Approval Date

1996-07-03

Regulatory Status

Discontinued

1991
31 Oct
Discontinued Application: 73585

Drug Name

SUDAFED 12 HOUR

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1991-10-31

73585 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

73585

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1991-10-31

Regulatory Status

Discontinued

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Drug Status Breakdown
23 total
  • Discontinued
  • OTC
  • Unclassified
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

BENADRYL

Application Number

5845

Product Number

1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Dosage Form

-

Strength

50MG

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