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 1 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Diotame Instydose	BISMUTH SUBSALICYLATE	Unifirst First Aid Corporation	5b214128-6980-0f84-e063-6294a90ad8ca	2026-09-10	Warnings	Exact identifier application number: M008
Regular Strength Pink Bismuth	BISMUTH SUBSALICYLATE	Raritan Pharmaceuticals Inc	89d18117-f0af-408a-a5ae-19da84158806	2026-09-09	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	The Kroger Co.	a03fabe0-4839-480e-8890-278e573cf4cc	2026-09-09	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	The Kroger Co.	5fa794f9-440c-479c-961c-34d298bb532b	2026-09-09	Warnings	Exact identifier application number: M008
DRx Choice Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	RARITAN PHAMACEUTICALS INC	75e8cd49-850f-4816-b350-ce76601ebfc0	2026-09-09	Warnings	Exact identifier application number: M008
Digestive Relief Regular Strength	BISMUTH SUBSALICYLATE	TARGET Corporation	90b0c541-2834-4ed7-9d01-76080dd73057	2026-09-09	Warnings	Exact identifier application number: M008
Pepto Bismol Fast Melts Fresh Berry Flavored	BISMUTH SUBSALICYLATE	The Procter & Gamble Manufacturing Company	039391d0-9ec1-45a3-84fa-b5f591794e41	2026-09-08	Warnings	Exact identifier application number: M008
Kroger Regular Strength Pink Bismuth	BISMUTH SUBSALICYLATE	KROGER COMPANY	97175691-4881-450d-a14c-3413ab47a3ca	2026-09-02	Warnings	Exact identifier application number: M008
Kroger Stomach Relief	BISMUTH SUBSALICYLATE	KROGER COMPANY	4963f568-9d8d-4ad0-b840-bed3f6f9cb7b	2026-09-01	Warnings	Exact identifier application number: M008
Ultra Strength digestive relief	BISMUTH SUBSALICYLATE	THE KROGER CO.	5e288108-1578-4379-a3d6-44b447187643	2026-09-01	Warnings	Exact identifier application number: M008
Kroger Digestive Relief	BISMUTH SUBSALICYLATE	KROGER COMPANY	2b32bee7-154a-4e5b-a811-066d1e6c5dcb	2026-09-01	Warnings	Exact identifier application number: M008
Regular Strength Stomach Relief	BISMUTH SUBSALICYLATE	Walmart Inc.	50a88db4-633d-d3bc-e063-6294a90a18c5	2026-08-29	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	H E B	7d721ce3-746f-49aa-916d-eb5a8b357813	2026-08-21	Warnings	Exact identifier application number: M008
Digestive Relief Regular Strength	BISMUTH SUBSALICYLATE	TARGET Corporation	e8107300-921c-4ba4-ad6e-f4cf1cd5c295	2026-08-20	Warnings	Exact identifier application number: M008
CVS Health Anti-Diarrheal Vanilla	BISMUTH SUBSALICYLATE	CVS Pharmacy,Inc.	ce1ed357-228b-452c-9bd4-6b0d20f41c1d	2026-08-17	Warnings	Exact identifier application number: M008
CVS Stomach Relief Ultra Strength	BISMUTH SUBSALICYLATE	CVS PHARMACY	a7fb56c5-9b34-48b8-a355-a16979a0aa7b	2026-08-17	Warnings	Exact identifier application number: M008
regular strength pink bismuth	BISMUTH SUBSALICYLATE	CVS PHARMACY, INC.	2b2a1de0-12fa-4800-91e8-f70a405eec72	2026-08-17	Warnings	Exact identifier application number: M008
CVS Health Stomach relief Cherry Flavor	BISMUTH SUBSALICYLATE	CVS PHARMACY,INC.	c0bb2b6e-8187-495e-8eac-2324fae86cf5	2026-08-13	Warnings	Exact identifier application number: M008
CVS Stomach Relief	BISMUTH SUBSALICYLATE	CVS	eb96b2bb-7b2a-4664-96ac-73c917c84c30	2026-08-13	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Care One (Retail Business Services, LLC.)	1af2a7dd-45d7-41a0-af61-4a588f1c1985	2026-08-12	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