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ACID REDUCER

Famotidine · Tablet, Film Coated

Over-the-counter ANDA 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
ACID REDUCER
Generic name
Famotidine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Publix Super Markets Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
11
Packages
17
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Cimetidine 200 mg/1 197505 View
Famotidine 10 mg/1 283641 View
Famotidine 20 mg/1 283641 View
Ranitidine Hydrochloride 75 mg/1 198191 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
28

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
077351
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 25, 2006
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
4
Products approved under application 077351.
Product Trade name Form Strength Ingredient Status TE Flags
077351-001 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077351.
Type No. Action Status Date Review
Supplement 28 Manufacturing (CMC) Approved August 18, 2021 Standard
Supplement 23 Labeling Approved February 18, 2021 Standard
Supplement 18 Manufacturing (CMC) Approved April 26, 2016 Unknown
Original application 1 Approved September 25, 2006 —

Review documents

  • 0 · Original application · September 27, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260818). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260818 HUMAN OTC DRUG · 20260803 HUMAN OTC DRUG · 20141210

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 foods and beverages

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 • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor

Warnings Allergy alert: Do not use if you are allergic to cimetidine 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 • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver 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 • you need to take this product for more than 14 days • stomach pain continues • your heartburn continues or worsens 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 • 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 • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver disease

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

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT (IN EACH TABLET) Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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
72288-470-76 72288-470 Amazon.com Services LLC 1 BOTTLE in 1 CARTON (72288-470-76) / 120 TABLET, FILM COATED in 1 BOTTLE (72288-470-00) July 30, 2026
72288-756-75 72288-756 Amazon.com Services LLC 1 BOTTLE in 1 CARTON (72288-756-75) / 90 TABLET, FILM COATED in 1 BOTTLE (72288-756-00) August 27, 2026
69842-659-63 69842-659 CVS Pharmacy 1 BOTTLE in 1 CARTON (69842-659-63) / 25 TABLET, FILM COATED in 1 BOTTLE April 4, 2022
69842-659-71 69842-659 CVS Pharmacy 1 BOTTLE in 1 CARTON (69842-659-71) / 50 TABLET, FILM COATED in 1 BOTTLE April 1, 2025
51316-511-63 51316-511 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-511-63) / 25 TABLET, FILM COATED in 1 BOTTLE April 13, 2026
51316-511-71 51316-511 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-511-71) / 50 TABLET, FILM COATED in 1 BOTTLE April 20, 2026
51316-511-78 51316-511 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-511-78) / 100 TABLET, FILM COATED in 1 BOTTLE April 22, 2026
51316-511-98 51316-511 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-511-98) / 75 TABLET, FILM COATED in 1 BOTTLE June 24, 2026
51316-816-39 51316-816 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-816-39) / 30 TABLET, FILM COATED in 1 BOTTLE August 3, 2026
59640-023-71 59640-023 H E B 1 BOTTLE in 1 CARTON (59640-023-71) / 50 TABLET, FILM COATED in 1 BOTTLE December 19, 2022
42507-141-75 42507-141 HyVee Inc 1 BOTTLE in 1 CARTON (42507-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE (42507-141-90) February 25, 2026
42507-194-01 42507-194 HyVee Inc 25 BLISTER PACK in 1 CARTON (42507-194-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK February 25, 2026
42507-194-71 42507-194 HyVee Inc 1 BOTTLE in 1 CARTON (42507-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE (42507-194-50) February 25, 2026
42507-194-78 42507-194 HyVee Inc 1 BOTTLE in 1 CARTON (42507-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE (42507-194-00) March 18, 2026
56062-088-02 56062-088 Publix Super Markets Inc 25 BLISTER PACK in 1 CARTON (56062-088-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 6, 2026
56062-141-65 56062-141 Publix Super Markets Inc 30 BLISTER PACK in 1 CARTON (56062-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK November 23, 2009
67091-244-30 67091-244 WinCo Foods, LLC 1 BOTTLE in 1 CARTON (67091-244-30) / 30 TABLET, FILM COATED in 1 BOTTLE January 8, 2015
72288-470 72288-470 Amazon.com Services LLC — July 30, 2026
72288-756 72288-756 Amazon.com Services LLC — August 27, 2026
69842-659 69842-659 CVS Pharmacy — April 4, 2022
51316-511 51316-511 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — April 13, 2026
51316-816 51316-816 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — August 3, 2026
59640-023 59640-023 H E B — December 19, 2022
42507-141 42507-141 HyVee Inc — October 19, 2009
42507-194 42507-194 HyVee Inc — February 25, 2026
56062-088 56062-088 Publix Super Markets Inc — March 6, 2026
56062-141 56062-141 Publix Super Markets Inc — November 23, 2009
67091-244 67091-244 WinCo Foods, LLC — August 2, 2012

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.