Pepto-Bismol

Product NDC: 58933-477
11-digit product format: 589330477
Labeler code: 58933
Product ID: 58933-477_eeb3d0e2-fd96-3ad5-e053-2a95a90a3231
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET
Route: ORAL
Labeler: Procter & Gamble Manufactura S de RL de CV
Application: M008
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-06-30
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58933-477		D	Discontinued by firm	2026-10-12
excluded package	package	58933-477	58933-477-01	D	Discontinued by firm	2026-10-12
excluded package	package	58933-477	58933-477-09	D	Discontinued by firm	2026-10-12
excluded package	package	58933-477	58933-477-10	D	Discontinued by firm	2026-10-12
excluded package	package	58933-477	58933-477-12	D	Discontinued by firm	2026-10-12

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58933-477-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58933-477-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58933-477-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58933-477-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58933-477-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58933-477-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58933-477-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58933-477-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58933-477-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58933-477-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58933-477-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58933-477-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58933-477-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58933-477-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58933-477-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58933-477-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58933-477-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58933-477-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58933-477-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58933-477-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58933-477-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58933-477-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58933-477-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58933-477-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58933-477-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58933-477-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58933-477-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58933-477-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58933-477-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58933-477-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58933-477-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58933-477-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58933-477-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58933-477-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58933-477-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58933-477-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58933-477-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58933-477-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58933-477-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58933-477-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58933-477-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58933-477-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58933-477-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58933-477-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58933-477-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58933-477-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58933-477-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58933-477-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58933-477-01	2021-06-10	Pepto-Bismol® Chewable Tablets
58933-477-09	2021-06-10	Pepto-Bismol® Chewable Tablets
58933-477-10	2021-06-10	Pepto-Bismol® Chewable Tablets
58933-477-12	2021-06-10	Pepto-Bismol® Chewable Tablets
58933-477-24	2021-06-10	Pepto-Bismol® Chewable Tablets
58933-477-01	2021-01-29	Pepto-Bismol® Chewable Tablets
58933-477-09	2021-01-29	Pepto-Bismol® Chewable Tablets
58933-477-10	2021-01-29	Pepto-Bismol® Chewable Tablets
58933-477-12	2021-01-29	Pepto-Bismol® Chewable Tablets
58933-477-24	2021-01-29	Pepto-Bismol® Chewable Tablets

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WinCo FOODS Ultra Strength Stomach Relief	BISMUTH SUBSALICYLATE	WINCO FOODS	acf82012-0e40-4d50-b1f1-f36dc3dfad84	2026-08-07	Warnings	Exact identifier application number: M008
WinCo FOODS Stomach Relief	BISMUTH SUBSALICYLATE	WINCO FOODS	19c14efc-bf5f-4ef5-a727-aaccfae093f0	2026-08-07	Warnings	Exact identifier application number: M008
WinCo FOODS Stomach Relief	BISMUTH SUBSALICYLATE	WINCO FOODS LLC	53ae695d-f812-462d-9487-8fb5db0aa27d	2026-08-07	Warnings	Exact identifier application number: M008
nexmed multi symptom stomach relief	BISMUTH SUBSALICYLATE 262 MG	Shield Pharmaceuticals Corp	212ccf1f-faaf-4f77-9722-28713fc42761	2026-08-05	Warnings	Exact identifier application number: M008
nexmed multi symptom stomach relief	BISMUTH SUBSALICYLATE 262 MG	Shield Pharmaceuticals Corp	7c0ca713-643a-46bd-9d9a-21ac39c808c4	2026-08-05	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Shield Pharmaceuticals Corp	8177318d-427b-4bfc-9d7f-51d1545f4eb8	2026-07-27	Warnings	Exact identifier application number: M008
FEVIA Diarrhea Control	BISMUTH SUBSALICYLATE	VIVUNT PHARMA LLC	4b20f189-e979-8198-e063-6294a90a7169	2026-07-16	Warnings	Exact identifier application number: M008
FEVIA Diarrhea Control	BISMUTH SUBSALICYLATE	VIVUNT PHARMA LLC	4bd5aa23-37aa-b818-e063-6394a90ae06c	2026-07-15	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	WALMART INC. (see also Equate)	369fe912-dd0e-4ff3-a597-5ee81332838a	2026-07-15	Warnings	Exact identifier application number: M008
Stomach Relief Ultra	BISMUTH SUBSALICYLATE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	642c14bd-be99-410b-9ba7-6e71c9705230	2026-07-15	Warnings	Exact identifier application number: M008
Good Neighbor Ultra Strength Stomach Relief	BISMUTH SUBSALICYLATE	AMERISOURCE BERGEN	71c30b10-db24-4a42-a4f4-db552e3d5fe6	2026-07-13	Warnings	Exact identifier application number: M008
Pepto Bismol CHEWABLES	BISMUTH SUBSALICYLATE	Select Consumer Group	5611c6cb-5c0b-cf4e-e063-6394a90abff8	2026-07-07	Warnings	Exact identifier application number: M008
Green Guard Instydose Mucus Relief	GUAIFENESIN	Unifirst First Aid Corporation	5b21bd13-d649-6570-e063-6394a90a51e9	2026-07-01	Warnings	Exact identifier application number: M008
Medique Guaicon Insydose	GUAIFENESIN	Unifirst First Aid Corporation	5b230d04-3cf2-51e0-e063-6294a90a2498	2026-07-01	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Rugby Laboratories	6166c04e-20c6-4678-b16d-517474445698	2026-06-26	Warnings	Exact identifier application number: M008
Stomach Relief regular strength	BISMUTH SUBSALICYLATE	CVS Pharmacy	1aa386ac-8ffd-4ba4-9b2e-19156d374c48	2026-06-25	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Walgreens	c367d913-e37b-467a-84da-dd6a22c793ae	2026-06-25	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate Pink Bismuth	BISMUTH SUBSALICYLATE	Hyvee Inc	4e575573-9ded-bfbf-e063-6394a90aed3b	2026-06-23	Warnings	Exact identifier application number: M008
Stomach reliever	BISMUTH SUBSALICYLATE	Hyvee Inc	44ead6e1-cd88-4602-e063-6394a90aed9f	2026-06-16	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate 262 mg	BISMUTH SUBSALICYLATE	Preferred Pharmaceuticals Inc.	f7627bf1-da97-4875-b614-5029663f7482	2026-06-08	Warnings	Exact identifier application number: M008

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308760	bismuth subsalicylate 262 MG Oral Tablet	PSN	8e84b0e3-a872-5437-e053-2a95a90abd19	1
702384	Pepto-Bismol 262 MG Oral Tablet	PSN	8e84b0e3-a872-5437-e053-2a95a90abd19	1
702384	bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]	SBD	8e84b0e3-a872-5437-e053-2a95a90abd19	1
308760	bismuth subsalicylate 262 MG Oral Tablet	SCD	8e84b0e3-a872-5437-e053-2a95a90abd19	1
702384	Pepto-bismol 262 MG Oral Tablet	SY	8e84b0e3-a872-5437-e053-2a95a90abd19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58933-477-01	58933047701	2 TABLET in 1 CELLO PACK (58933-477-01)	2 tablet	2004-06-30	0000-00-00	No	No	Current
58933-477-09	58933047709	5 CELLO PACK in 1 CARTON (58933-477-09) > 6 TABLET in 1 CELLO PACK	5 cello pack	2004-06-30	0000-00-00	No	No	Current
58933-477-10	58933047710	8 CELLO PACK in 1 CARTON (58933-477-10) > 6 TABLET in 1 CELLO PACK	8 cello pack	2004-06-30	0000-00-00	No	No	Current
58933-477-12	58933047712	2 CELLO PACK in 1 CARTON (58933-477-12) > 6 TABLET in 1 CELLO PACK	2 cello pack	2004-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pepto-Bismol® Chewable Tablets	Procter & Gamble Manufactura S de RL de CV	2023-10-12	HUMAN OTC DRUG LABEL	8
Pepto-Bismol	Savings Distributors LLC	2019-07-25	HUMAN OTC DRUG LABEL	1