Paracetamol Otc - FDA Approved Drugs

FDA Approved Drugs Database
Paracetamol Otc

Paracetamol Otc

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

OTC
Latest Approval
Jul 24, 2026
Data Source
U.S. FDA
First Approval
Jan 01, 1982
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FDA Approved Drug Records (27 records)
Clear
2023
28 Feb
OTC Application: 214836

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Feb 28, 2023

214836 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 214836
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Feb 28, 2023

Regulatory Status

OTC

2023
13 Jul
OTC Application: 216592

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Jul 13, 2023

216592 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 216592
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Jul 13, 2023

Regulatory Status

OTC

2024
23 Aug
OTC Application: 218247

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Aug 23, 2024

218247 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 218247
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Aug 23, 2024

Regulatory Status

OTC

2024
26 Apr
OTC Application: 218311

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Apr 26, 2024

218311 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 218311
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Apr 26, 2024

Regulatory Status

OTC

2025
11 Dec
OTC Application: 220126

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Dec 11, 2025

220126 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 220126
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Dec 11, 2025

Regulatory Status

OTC

1994
08 Jun
OTC Application: 19872

Drug Name

TYLENOL

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Jun 08, 1994

19872 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 19872
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Jun 08, 1994

Regulatory Status

OTC

2001
11 Jan
OTC Application: 19872

Drug Name

TYLENOL

Product Number

2

Dosage Form

-

Strength

650MG

Approval Date

Jan 11, 2001

19872 / 2

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 19872
Product No.: 2

Product

Dosage Form: -
Strength: 650MG

Approval Date

Jan 11, 2001

Regulatory Status

OTC

2026
24 Jul
OTC Application: 219962

Drug Name

TYLENOL WITH NAPROXEN

Product Number

1

Dosage Form

-

Strength

325MG;110MG

Approval Date

Jul 24, 2026

219962 / 1

Active Ingredient

ACETAMINOPHEN; NAPROXEN SODIUM

Identifiers

Application No.: 219962
Product No.: 1

Product

Dosage Form: -
Strength: 325MG;110MG

Approval Date

Jul 24, 2026

Regulatory Status

OTC

2023
01 Aug
OTC Application: 216999

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Aug 01, 2023

216999 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 216999
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Aug 01, 2023

Regulatory Status

OTC

2016
09 Nov
OTC Application: 207229

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Nov 09, 2016

207229 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 207229
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Nov 09, 2016

Regulatory Status

OTC

2024
26 Mar
OTC Application: 218359

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Mar 26, 2024

218359 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 218359
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Mar 26, 2024

Regulatory Status

OTC

2022
02 Feb
OTC Application: 211695

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

Feb 02, 2022

211695 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Identifiers

Application No.: 211695
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;250MG;65MG

Approval Date

Feb 02, 2022

Regulatory Status

OTC

2019
16 Apr
OTC Application: 211544

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Apr 16, 2019

211544 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 211544
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Apr 16, 2019

Regulatory Status

OTC

2021
23 Feb
OTC Application: 214039

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

Feb 23, 2021

214039 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Identifiers

Application No.: 214039
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;250MG;65MG

Approval Date

Feb 23, 2021

Regulatory Status

OTC

1987
06 Apr
OTC Application: 70607

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

Apr 06, 1987

70607 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 70607
Product No.: 1

Product

Dosage Form: -
Strength: 120MG

Approval Date

Apr 06, 1987

Regulatory Status

OTC

1986
01 Dec
OTC Application: 70608

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Dec 01, 1986

70608 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 70608
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Dec 01, 1986

Regulatory Status

OTC

2000
25 Feb
OTC Application: 75077

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Feb 25, 2000

75077 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 75077
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Feb 25, 2000

Regulatory Status

OTC

2001
26 Nov
OTC Application: 75794

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

Nov 26, 2001

75794 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Identifiers

Application No.: 75794
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;250MG;65MG

Approval Date

Nov 26, 2001

Regulatory Status

OTC

2021
25 Aug
OTC Application: 215486

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Aug 25, 2021

215486 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 215486
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Aug 25, 2021

Regulatory Status

OTC

2023
10 Jul
OTC Application: 216994

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Jul 10, 2023

216994 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 216994
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Jul 10, 2023

Regulatory Status

OTC

2002
19 Mar
OTC Application: 76200

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

Mar 19, 2002

76200 / 1

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 76200
Product No.: 1

Product

Dosage Form: -
Strength: 650MG

Approval Date

Mar 19, 2002

Regulatory Status

OTC

1982
01 Jan
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

Jan 01, 1982

18337 / 2

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18337
Product No.: 2

Product

Dosage Form: -
Strength: 325MG

Approval Date

Jan 01, 1982

Regulatory Status

OTC

1983
12 Sep
OTC Application: 18337

Drug Name

ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

Sep 12, 1983

18337 / 3

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18337
Product No.: 3

Product

Dosage Form: -
Strength: 120MG

Approval Date

Sep 12, 1983

Regulatory Status

OTC

2026
02 Jan
OTC Application: 219053

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

Jan 02, 2026

219053 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 219053
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Jan 02, 2026

Regulatory Status

OTC

1992
26 Aug
OTC Application: 18337

Drug Name

INFANTS FEVERALL

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

Aug 26, 1992

18337 / 4

Active Ingredient

ACETAMINOPHEN

Identifiers

Application No.: 18337
Product No.: 4

Product

Dosage Form: -
Strength: 80MG

Approval Date

Aug 26, 1992

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

Feb 28, 2020

211733 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 211733
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;125MG

Approval Date

Feb 28, 2020

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

Jan 14, 1998

20802 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Identifiers

Application No.: 20802
Product No.: 1

Product

Dosage Form: -
Strength: 250MG;250MG;65MG

Approval Date

Jan 14, 1998

Regulatory Status

OTC

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Related Databases
5 of 6 have records
Drug Status Breakdown
27 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
Record Details Preview

Click "View Details" on any record above to expand full details inline.

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Identifiers

Application No.: 214836
Product No.: 1

100% Official Data

Based on the U.S. FDA Orange Book

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FDA Approved Drugs data is based on publicly available U.S. Food and Drug Administration drug product information, including Orange Book data.
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