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Pepcid Complete

Famotidine, Calcium carbonate, and Magnesium hydroxide · Tablet, Chewable

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 Complete
Generic name
Famotidine, Calcium carbonate, and Magnesium hydroxide
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
NDA · NDA
Labeler
Kenvue Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
10
Packages
30
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
Calcium Carbonate 800 mg/1 283641 View
Famotidine 10 mg/1 283641 View
Magnesium Hydroxide 165 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
40

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
020958
Application type
NDA · New Drug Application
Approval date
October 16, 2000
Sponsor
KENVUE BRANDS
Products on application
1
Submissions recorded
22
Products approved under application 020958.
Product Trade name Form Strength Ingredient Status TE Flags
020958-001 PEPCID COMPLETE TABLET, CHEWABLE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 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 020958.
Type No. Action Status Date Review
Supplement 44 Labeling Approved September 30, 2025 Standard
Supplement 43 Labeling Approved February 11, 2025 Standard
Supplement 41 Labeling Approved January 31, 2025 Standard
Supplement 42 Manufacturing (CMC) Approved January 17, 2025 N/A
Supplement 29 Labeling Approved June 11, 2019 Standard
Supplement 28 Labeling Approved April 9, 2019 Standard
Supplement 27 Labeling Approved December 21, 2018 Standard
Supplement 25 Labeling Approved June 8, 2016 Standard
Supplement 23 Manufacturing (CMC) Approved July 14, 2015 Standard
Supplement 21 Manufacturing (CMC) Approved March 20, 2014 Standard
Supplement 20 Manufacturing (CMC) Approved December 7, 2013 Standard
Supplement 18 Labeling Approved July 30, 2013 Standard
Supplement 17 Manufacturing (CMC) Approved April 1, 2013 Standard
Supplement 15 Manufacturing (CMC) Approved November 18, 2008 N/A
Supplement 13 Labeling Approved June 9, 2006 Standard
Supplement 12 Labeling Approved July 18, 2005 Standard
Supplement 10 Labeling Approved October 27, 2004 Standard
Supplement 7 Labeling Approved November 5, 2003 Standard
Supplement 3 Manufacturing (CMC) Approved November 22, 2002 Standard
Supplement 2 Manufacturing (CMC) Approved November 6, 2001 Standard
Supplement 1 Manufacturing (CMC) Approved September 24, 2001 Standard
Original application 1 Type 4 - New Combination Approved October 16, 2000 Standard

Review documents

  • 0 · Supplement · October 2, 2025
  • 0 · Supplement · October 2, 2025
  • 0 · Supplement · February 12, 2025
  • 0 · Supplement · February 12, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 4, 2025
  • 0 · Supplement · February 4, 2025
  • 0 · Supplement · June 17, 2019
  • 0 · Supplement · June 12, 2019
  • 0 · Supplement · April 16, 2019
  • 0 · Supplement · April 15, 2019
  • 0 · Supplement · December 31, 2018
  • 0 · Supplement · December 21, 2018
  • 0 · Supplement · June 14, 2016
  • 0 · Supplement · June 14, 2016
  • 0 · Supplement · September 19, 2013
  • 0 · Supplement · August 1, 2013
  • 0 · Supplement · March 27, 2012
  • 0 · Supplement · November 18, 2008
  • 0 · Supplement · June 18, 2007
  • 0 · Supplement · June 12, 2006
  • 0 · Supplement · July 21, 2005
  • 0 · Supplement · July 21, 2005
  • 0 · Supplement · October 29, 2004
  • 0 · Supplement · November 13, 2003
  • 0 · Original application · September 25, 2003
  • 0 · Supplement · April 25, 2003
  • 0 · Original application · October 16, 2000
  • 0 · Original application · October 16, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240415). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240415 HUMAN OTC DRUG · 20240125

Indications and Usage

openFDA Drug Labeling

Use relieves heartburn associated with acid indigestion and sour stomach

Purpose

openFDA Drug Labeling

Active ingredients (in each chewable tablet) Purposes Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing. do not use more than 2 chewable 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. Antacids and 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)

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

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 ingredients (in each chewable tablet) Purposes Famotidine 10 mg Acid reducer Calcium carbonate 800 mg Antacid Magnesium hydroxide 165 mg Antacid

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
16837-246-25 16837-246 Kenvue Brands LLC 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25) January 1, 2009
16837-246-50 16837-246 Kenvue Brands LLC 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50) January 1, 2009
16837-298-12 16837-298 Kenvue Brands LLC 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-12) March 1, 2009
16837-298-25 16837-298 Kenvue Brands LLC 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-25) March 1, 2009
16837-298-50 16837-298 Kenvue Brands LLC 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-50) March 1, 2009
16837-298-52 16837-298 Kenvue Brands LLC 50 POUCH in 1 CARTON (16837-298-52) / 1 TABLET, CHEWABLE in 1 POUCH October 31, 2025
16837-298-65 16837-298 Kenvue Brands LLC 2500 POUCH in 1 CARTON (16837-298-65) / 1 TABLET, CHEWABLE in 1 POUCH June 15, 2020
16837-298-67 16837-298 Kenvue Brands LLC 4 POUCH in 1 CARTON (16837-298-67) / 1 TABLET, CHEWABLE in 1 POUCH June 15, 2020
16837-298-68 16837-298 Kenvue Brands LLC 8 POUCH in 1 CARTON (16837-298-68) / 1 TABLET, CHEWABLE in 1 POUCH June 15, 2020
16837-298-70 16837-298 Kenvue Brands LLC 70 TABLET, CHEWABLE in 1 BOTTLE (16837-298-70) August 29, 2025
16837-298-72 16837-298 Kenvue Brands LLC 72 TABLET, CHEWABLE in 1 BOTTLE (16837-298-72) May 29, 2026
16837-891-25 16837-891 Kenvue Brands LLC 25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-25) March 1, 2009
16837-891-50 16837-891 Kenvue Brands LLC 50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-50) March 1, 2009
16837-891-65 16837-891 Kenvue Brands LLC 25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-65) January 11, 2024
16837-891-66 16837-891 Kenvue Brands LLC 50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-66) December 14, 2023
16837-891-70 16837-891 Kenvue Brands LLC 70 TABLET, CHEWABLE in 1 BOTTLE (16837-891-70) August 29, 2025
16837-891-72 16837-891 Kenvue Brands LLC 72 TABLET, CHEWABLE in 1 BOTTLE (16837-891-72) May 29, 2026
66715-6422-7 66715-6422 Lil' Drug Store Products, Inc. 25 POUCH in 1 BOX, UNIT-DOSE (66715-6422-7) / 1 TABLET, CHEWABLE in 1 POUCH April 19, 2022
66715-6422-8 66715-6422 Lil' Drug Store Products, Inc. 30 POUCH in 1 BOX, UNIT-DOSE (66715-6422-8) / 1 TABLET, CHEWABLE in 1 POUCH April 19, 2022
66715-9822-2 66715-9822 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-9822-2) / 1 TABLET, CHEWABLE in 1 POUCH July 17, 2020
66715-9822-3 66715-9822 Lil' Drug Store Products, Inc. 3 POUCH in 1 CARTON (66715-9822-3) / 1 TABLET, CHEWABLE in 1 POUCH April 7, 2022
53209-4001-2 53209-4001 Morning Star OTC 25 BLISTER PACK in 1 PACKET (53209-4001-2) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1) June 19, 2025
67751-202-01 67751-202 Navajo Manufacturing Company Inc 1 POUCH in 1 CARTON (67751-202-01) / 1 TABLET, CHEWABLE in 1 POUCH August 6, 2020
67751-202-02 67751-202 Navajo Manufacturing Company Inc 2 POUCH in 1 CARTON (67751-202-02) / 1 TABLET, CHEWABLE in 1 POUCH August 6, 2020
70264-034-01 70264-034 R J General Corporation 50 TABLET, CHEWABLE in 1 CARTON (70264-034-01) December 28, 2022
73097-017-25 73097-017 Savings Distributors LLC 25 POUCH in 1 CARTON (73097-017-25) / 1 TABLET, CHEWABLE in 1 POUCH June 1, 2026
85237-1948-1 85237-1948 Select Consumer Group 1 POUCH in 1 BLISTER PACK (85237-1948-1) / 1 TABLET, CHEWABLE in 1 POUCH (85237-1948-0) June 5, 2024
85237-1948-2 85237-1948 Select Consumer Group 2 POUCH in 1 BLISTER PACK (85237-1948-2) / 1 TABLET, CHEWABLE in 1 POUCH (85237-1948-0) June 5, 2024
85237-1948-3 85237-1948 Select Consumer Group 20 POUCH in 1 CARTON (85237-1948-3) / 1 TABLET, CHEWABLE in 1 POUCH (85237-1948-0) June 5, 2024
85237-1948-4 85237-1948 Select Consumer Group 25 POUCH in 1 CARTON (85237-1948-4) / 1 TABLET, CHEWABLE in 1 POUCH (85237-1948-0) June 5, 2024
16837-246 16837-246 Kenvue Brands LLC — January 1, 2009
16837-298 16837-298 Kenvue Brands LLC — March 1, 2009
16837-891 16837-891 Kenvue Brands LLC — March 1, 2009
66715-6422 66715-6422 Lil' Drug Store Products, Inc. — April 19, 2022
66715-9822 66715-9822 Lil' Drug Store Products, Inc. — July 17, 2020
53209-4001 53209-4001 Morning Star OTC — June 19, 2025
67751-202 67751-202 Navajo Manufacturing Company Inc — August 6, 2020
70264-034 70264-034 R J General Corporation — January 9, 2022
73097-017 73097-017 Savings Distributors LLC — June 1, 2026
85237-1948 85237-1948 Select Consumer Group — March 1, 2009

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.