Bionpharma OTC
FDA Approved Drugs

Bionpharma 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 15
  • Latest Approval Date Sep 19, 2025
  • Data Source FDA
  • First Approval Date Oct 18, 2002
All
126
View
Discontinued
13
View
OTC
15
View
RX
98
View
Company Overview

Company

Bionpharma OTC

Country

U.S.A

Social Profiles

Company Snapshot

Bionpharma OTC

Suite 2-4B, 600 Alexander Road, Princeton, NJ 08540

U.S.A

www.bionpharma.com/index.html admin@bionpharma.com View on Map
FDA Approved Drug Records ( 15 records )
2023
01 Aug
OTC Application: 216999

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2023-08-01

216999 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

216999

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2023-08-01

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

22429 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

22429 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

22429 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
23 Jul
OTC Application: 22429

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

22429 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

22429

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-07-23

Regulatory Status

OTC

2009
24 Mar
OTC Application: 78682

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2009-03-24

78682 / 1

Active Ingredient

IBUPROFEN

Application Number

78682

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2009-03-24

Regulatory Status

OTC

2010
22 Nov
OTC Application: 90397

Drug Name

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2010-11-22

90397 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Application Number

90397

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2010-11-22

Regulatory Status

OTC

2005
04 Aug
OTC Application: 21855

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-08-04

21855 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

21855

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2005-08-04

Regulatory Status

OTC

2005
04 Aug
OTC Application: 21855

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-08-04

21855 / 2

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

21855

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2005-08-04

Regulatory Status

OTC

2025
19 Sep
OTC Application: 220100

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/7.5ML

Approval Date

2025-09-19

220100 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

220100

Product Number

1

Dosage Form

-

Strength

1MG/7.5ML

Approval Date

2025-09-19

Regulatory Status

OTC

2021
10 Sep
OTC Application: 213484

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-09-10

213484 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

213484

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2021-09-10

Regulatory Status

OTC

2018
21 Dec
OTC Application: 202538

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-12-21

202538 / 1

Active Ingredient

LORATADINE

Application Number

202538

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-12-21

Regulatory Status

OTC

2024
14 May
OTC Application: 218017

Drug Name

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2024-05-14

218017 / 1

Active Ingredient

LORATADINE; PSEUDOEPHEDRINE SULFATE

Application Number

218017

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2024-05-14

Regulatory Status

OTC

2002
18 Oct
OTC Application: 21472

Drug Name

MIDOL LIQUID GELS

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-10-18

21472 / 1

Active Ingredient

IBUPROFEN

Application Number

21472

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2002-10-18

Regulatory Status

OTC

2006
17 Feb
OTC Application: 21920

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2006-02-17

21920 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

21920

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2006-02-17

Regulatory Status

OTC

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Drug Status Breakdown
15 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 AND IBUPROFEN

Application Number

216999

Product Number

1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Dosage Form

-

Strength

250MG;125MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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