Taro Pharmaceutical Industries OTC
FDA Approved Drugs

Taro Pharmaceutical Industries 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.

OTC
  • Total Records 17
  • Latest Approval Date Jan 02, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
209
View
Unclassified
1
View
Discontinued
83
View
OTC
17
View
RX
108
View
Company Overview

Company

Taro Pharmaceutical Industries OTC

Country

U.S.A

Website

Visit Website

Email

enquiries@pharmacompass.com

Social Profiles

Company Snapshot

Taro Pharmaceutical Industries OTC

Three Skyline Drive Hawthorne, NY 10532

U.S.A

www.taro.com/ enquiries@pharmacompass.com View on Map
FDA Approved Drug Records ( 17 records )
1982
01 Jan
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

1982-01-01

18337 / 2

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

1982-01-01

Regulatory Status

OTC

1983
12 Sep
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-09-12

18337 / 3

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

1983-09-12

Regulatory Status

OTC

2026
02 Jan
OTC Application: 219053

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2026-01-02

219053 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

219053

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2026-01-02

Regulatory Status

OTC

2008
22 Apr
OTC Application: 90182

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90182 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90182

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

OTC

2011
20 May
OTC Application: 201546

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

201546 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

201546

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

Regulatory Status

OTC

2008
22 Apr
OTC Application: 90182

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90182 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90182

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

OTC

2011
20 May
OTC Application: 201546

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

201546 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

201546

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2011-05-20

Regulatory Status

OTC

2017
09 Nov
OTC Application: 208123

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

208123 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

208123

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

Regulatory Status

OTC

2017
09 Nov
OTC Application: 208123

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

208123 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

208123

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

2017-11-09

Regulatory Status

OTC

1992
26 Aug
OTC Application: 18337

Drug Name

INFANTS FEVERALL

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

1992-08-26

18337 / 4

Active Ingredient

ACETAMINOPHEN

Application Number

18337

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

1992-08-26

Regulatory Status

OTC

2020
06 May
OTC Application: 210720

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-05-06

210720 / 1

Active Ingredient

IVERMECTIN

Application Number

210720

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-05-06

Regulatory Status

OTC

2004
20 Aug
OTC Application: 76805

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

76805 / 1

Active Ingredient

LORATADINE

Application Number

76805

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-08-20

Regulatory Status

OTC

2015
31 Jul
OTC Application: 201865

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-07-31

201865 / 1

Active Ingredient

LORATADINE

Application Number

201865

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-07-31

Regulatory Status

OTC

2018
31 Dec
OTC Application: 209074

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-31

209074 / 1

Active Ingredient

MINOXIDIL

Application Number

209074

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2018-12-31

Regulatory Status

OTC

2019
22 Apr
OTC Application: 209074

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2019-04-22

209074 / 2

Active Ingredient

MINOXIDIL

Application Number

209074

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2019-04-22

Regulatory Status

OTC

2024
26 Nov
OTC Application: 218175

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-11-26

218175 / 1

Active Ingredient

MINOXIDIL

Application Number

218175

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2024-11-26

Regulatory Status

OTC

2025
30 Jun
OTC Application: 217998

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-06-30

217998 / 1

Active Ingredient

MINOXIDIL

Application Number

217998

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2025-06-30

Regulatory Status

OTC

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Drug Status Breakdown
17 total
  • OTC
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

ACETAMINOPHEN

Application Number

18337

Product Number

2

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

325MG

FDA Approved Drug Data

Approved drug product information

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