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Pepcid Complete, TRAVEL BASIX

Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet · Tablet, Chewable

Over-the-counter NDA RLD
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, TRAVEL BASIX
Generic name
Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
NDA · NDA
Labeler
Lil' Drug Store Products, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
2
Packages
2
Data completeness
54% 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
4

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

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
66715-6522-2 66715-6522 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-6522-2) / 1 TABLET, CHEWABLE in 1 POUCH May 6, 2022
66715-7822-2 66715-7822 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-7822-2) / 1 TABLET, CHEWABLE in 1 POUCH November 29, 2022
66715-6522 66715-6522 Lil' Drug Store Products, Inc. — May 6, 2022
66715-7822 66715-7822 Lil' Drug Store Products, Inc. — November 29, 2022

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
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.