Pepto Bismol

Product NDC: 29485-6754
11-digit product format: 294856754
Labeler code: 29485
Product ID: 29485-6754_f202d97c-160b-2562-e053-2a95a90a4b2a
Type: HUMAN OTC DRUG
Nonproprietary name: BISMUTH SUBSALICYLATE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Mechanical Servants, LLC
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-02-06
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	29485-6754		D	Discontinued by firm		2026-10-15
excluded package	package	29485-6754	29485-6754-6	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	29485-6754		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	29485-6754	29485-6754-6	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-6754	PEPTO BISMOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]	6	Legacy NDC	20230720_d04e42bf-2748-f12b-e053-2a95a90a35e5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
62TEY51RR1	BISMUTH SUBSALICYLATE	14882-18-9	BISMUTH SUBSALICYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-6754-6	29485675406	3 CELLO PACK in 1 BLISTER PACK (29485-6754-6) > 2 TABLET, CHEWABLE in 1 CELLO PACK	3 cello pack	2017-02-06	0000-00-00	No	No	Current