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	2026-10-15
excluded package	package	58933-477	58933-477-01	D	Discontinued by firm	2026-10-15
excluded package	package	58933-477	58933-477-09	D	Discontinued by firm	2026-10-15
excluded package	package	58933-477	58933-477-10	D	Discontinued by firm	2026-10-15
excluded package	package	58933-477	58933-477-12	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 · 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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	P & L Development, LLC	7a461b91-d11f-4cb9-be61-c7d91d278302	2024-04-16	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Gobrands, Inc. (Goodnow)	cd647eb7-6e03-415c-8249-89c126824d00	2024-04-03	Warnings	Exact identifier application number: M008
Stomach Relief Ultra Strength	BISMUTH SUBSALICYLATE	Care One (Retail Business Services, LLC.)	c443b640-18b0-4b7d-a13c-0accb915a801	2024-03-05	Warnings	Exact identifier application number: M008
Stomach Relief - Regular Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	970b4118-2c2e-4806-8fe8-937ba06cf6e9	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief, Maximum Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	cdd436f6-b769-49aa-9e6c-da512da9e6e3	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief - Maximum Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	15cd9163-16d6-4332-9e26-77c05e0a26a7	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Demoulas Super Markets Inc	9a95d198-f3ba-4bc3-a6f1-e065eb7e86f0	2023-12-29	Warnings	Exact identifier application number: M008
Stomach Relief Maximum Strength	BISMUTH SUBSALICYLATE	Demoulas Super Markets Inc	b2d55045-d4a4-4167-a20c-42932f35bab2	2023-12-29	Warnings	Exact identifier application number: M008
STOMACH RELIEF	BISMUTH SUBSALICYLATE	Consumer Value Products, Inc.	7526a3f2-ce7c-46c8-8ddf-1bcaf313876d	2023-12-29	Warnings	Exact identifier application number: M008
Estomaquil Polvo	BISMUTH SUBSALICYLATE	ProMex LLC	cf94c99a-c489-45ec-bb13-3e6959e377de	2023-11-29	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Care One (Retail Business Services, LLC.)	3c53adaa-275f-4164-b21e-285e4f03433e	2023-10-05	Warnings	Exact identifier application number: M008
Pepto-Bismol Chewable, TRAVEL BASIX	BISMUTH SUBSALICYLATE	Lil' Drug Store Products, Inc.	dd2f2205-34d1-4960-bf37-bb8d534cd0e1	2023-10-03	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	CDMA- QC	fe3cd0ce-933b-4ad3-a34f-c057a9356158	2021-06-16	Warnings	Exact identifier application number: M008
Topcare Stomach Relief Original Strength	BISMUTH SUBSALICYLATE	TopCo Associates, LLC	e4b1929c-0967-44ea-8552-6549aa2a464e	2018-12-14	Warnings	Exact identifier application number: M008
Bismuth	BISMUTH SUBSALICYLATE	Allegiant Health	015ca07a-f6b5-4741-a7b0-821cf6d4e418	2018-11-07	Warnings	Exact identifier application number: M008
Gastrobiz	BISMUTH SUBSALICYLATE	Allegiant Health	aa516512-afd7-453f-9c73-5fa930cafac3	2018-09-11	Warnings	Exact identifier application number: M008
Pep Tum	BISMUTH SUBSALICYLATE	First Aid Direct	bf966e9f-2f95-41cd-a6e5-b8eb521181d8	2017-12-22	Warnings	Exact identifier application number: M008
Bismuth Chewable	BISMUTH SUBSALICYLATE 262 MG	Marc Glassman, Inc.	cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e	2016-12-19	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