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Pepcid AC

Famotidine · Tablet, Film Coated

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Pepcid AC
Generic name
Famotidine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Kenvue Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
3
Packages
23
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Famotidine 10 mg/1 283641 View
Famotidine 20 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
26

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H2 Receptor Antagonists [MoA] MoA All 48 members
Histamine-2 Receptor Antagonist [EPC] EPC All 48 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020325
Application type
NDA · New Drug Application
Approval date
April 28, 1995
Sponsor
KENVUE BRANDS
Products on application
2
Submissions recorded
28
Products approved under application 020325.
Product Trade name Form Strength Ingredient Status TE Flags
020325-001 PEPCID AC TABLET FAMOTIDINE Over-the-counter — RLD
020325-002 PEPCID AC TABLET FAMOTIDINE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020325.
Type No. Action Status Date Review
Supplement 45 Labeling Approved February 12, 2026 Standard
Supplement 43 Manufacturing (CMC) Approved December 14, 2023 N/A
Supplement 41 Labeling Approved December 15, 2022 Standard
Supplement 37 Manufacturing (CMC) Approved February 18, 2022 N/A
Supplement 33 Labeling Approved April 9, 2019 Standard
Supplement 31 Manufacturing (CMC) Approved August 1, 2016 Standard
Supplement 30 Labeling Approved June 8, 2016 Standard
Supplement 29 Manufacturing (CMC) Approved May 5, 2016 Standard
Supplement 28 Manufacturing (CMC) Approved July 9, 2015 Standard
Supplement 27 Manufacturing (CMC) Approved May 6, 2015 Standard
Supplement 26 Manufacturing (CMC) Approved April 20, 2015 Standard
Supplement 25 Manufacturing (CMC) Approved April 1, 2013 Standard
Supplement 24 Labeling Approved October 11, 2012 Standard
Supplement 19 Labeling Approved June 9, 2006 Standard
Supplement 17 Labeling Approved October 27, 2004 Standard
Supplement 15 Efficacy Approved September 23, 2003 Standard
Supplement 13 Labeling Approved March 1, 2002 Standard
Supplement 11 Manufacturing (CMC) Approved April 5, 2000 Standard
Supplement 10 Manufacturing (CMC) Approved February 10, 2000 Standard
Supplement 7 Efficacy Approved November 9, 1998 Standard
Supplement 9 Manufacturing (CMC) Approved November 5, 1998 Standard
Supplement 8 Manufacturing (CMC) Approved April 15, 1998 Standard
Supplement 6 Manufacturing (CMC) Approved September 26, 1997 Standard
Supplement 1 Manufacturing (CMC) Approved May 31, 1996 Standard
Supplement 3 Manufacturing (CMC) Approved May 3, 1996 Standard
Supplement 4 Manufacturing (CMC) Approved April 23, 1996 Standard
Supplement 2 Manufacturing (CMC) Approved October 2, 1995 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved April 28, 1995 Standard

Review documents

  • 0 · Supplement · February 13, 2026
  • 0 · Supplement · February 13, 2026
  • 0 · Supplement · December 15, 2023
  • 0 · Supplement · December 15, 2023
  • 0 · Supplement · December 22, 2022
  • 0 · Supplement · December 20, 2022
  • 0 · Supplement · February 23, 2022
  • 0 · Supplement · April 26, 2019
  • 0 · Supplement · April 10, 2019
  • 0 · Supplement · June 13, 2016
  • 0 · Supplement · June 9, 2016
  • 0 · Supplement · April 11, 2016
  • 0 · Supplement · May 29, 2007
  • 0 · Supplement · June 12, 2006
  • 0 · Supplement · October 29, 2004
  • 0 · Supplement · September 30, 2003
  • 0 · Supplement · September 30, 2003
  • 0 · Supplement · March 1, 2002
  • 0 · Supplement · March 1, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240109). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240109

Indications and Usage

openFDA Drug Labeling

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Purpose

openFDA Drug Labeling

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Famotidine 20 mg

Adverse event reports

Source: openFDA FAERS
118,947
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FAMOTIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
16837-855-02 16837-855 Kenvue Brands LLC 2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH June 5, 2023
16837-855-09 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-12 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-13 16837-855 Kenvue Brands LLC 1 TABLET, FILM COATED in 1 POUCH (16837-855-13) September 1, 2003
16837-855-14 16837-855 Kenvue Brands LLC 5 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACK September 1, 2003
16837-855-15 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-16 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-18 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-19 16837-855 Kenvue Brands LLC 1 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK April 27, 2015
16837-855-20 16837-855 Kenvue Brands LLC 2 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC August 22, 2014
16837-855-24 16837-855 Kenvue Brands LLC 2500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCH June 5, 2023
16837-855-50 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-52 16837-855 Kenvue Brands LLC 50 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH September 1, 2003
16837-855-70 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-75 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-80 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-85 16837-855 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC September 1, 2003
16837-855-90 16837-855 Kenvue Brands LLC 125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90) March 15, 2021
16837-872-20 16837-872 Kenvue Brands LLC 3 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK January 21, 2011
16837-872-22 16837-872 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC January 21, 2011
16837-872-30 16837-872 Kenvue Brands LLC 3 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK October 1, 1995
16837-872-90 16837-872 Kenvue Brands LLC 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC October 1, 1995
66715-9748-8 66715-9748 Lil' Drug Store Products, Inc. 5 BLISTER PACK in 1 CARTON (66715-9748-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK April 1, 2020
16837-855 16837-855 Kenvue Brands LLC — September 1, 2003
16837-872 16837-872 Kenvue Brands LLC — October 1, 1995
66715-9748 66715-9748 Lil' Drug Store Products, Inc. — April 1, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.