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 8 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Stomach Relief cherry	BISMUTH SUBSALICYLATE	Topco Associates, LLC	154b4b8f-c4d6-414b-aac3-88475669e19d	2024-12-26	Warnings	Exact identifier application number: M008
Topco Stomach Relief	BISMUTH SUBSALICYLATE	Topco Associates, LLC	7a5be682-f13b-41a4-bf8c-724bffab2e92	2024-12-26	Warnings	Exact identifier application number: M008
HEB Stomach Relief Cherry	BISMUTH SUBSALICYLATE	H E B	0277d4d7-c254-4eea-8f2e-4936d015a80f	2024-12-26	Warnings	Exact identifier application number: M008
Equaline Maximum Strength Stomach Relief	BISMUTH SUBSALICYLATE	UNITED NATURAL FOODS, INC. DBA UNFI	716a7b86-4f6e-493d-ba29-d81f6ecafbf2	2024-12-20	Warnings	Exact identifier application number: M008
Equaline Stomach Relief	BISMUTH SUBSALICYLATE	UNITED NATURAL FOODS, INC. DBA UNFI	d0607a4e-de81-4881-abc7-cf0cc72a9f92	2024-12-20	Warnings	Exact identifier application number: M008
Guardian Pink Bismuth	BISMUTH SUBSALICYLATE	Guardian Drug Company	7e83fdf2-4007-46a8-ae9d-eab5a8ff1915	2024-12-18	Warnings	Exact identifier application number: M008
Stomach Relief, Caseys 4good	BISMUTH SUBSALICYLATE SUSPENSION	Lil' Drug Store Products, Inc.	030bb176-08ae-6c68-e063-6394a90af527	2024-12-16	Warnings	Exact identifier application number: M008
Foster and Thrive Stomach Relief	BISMUTH SUBSALICYLATE	Strategic Sourcing Services LLC	c73c6650-a7ac-4942-ae07-0bc660a0081f	2024-12-12	Warnings	Exact identifier application number: M008
Foster and Thrive Regular Strength Stomach Relief 527	BISMUTH SUBSALICYLATE 525 MG	Strategic Sourcing Services LLC	f204f9ab-645b-4656-93a1-90aa4c369922	2024-12-12	Warnings	Exact identifier application number: M008
Foster and Thrive Stomach Relief	BISMUTH SUBSALICYLATE	Strategic Sourcing Services LLC	d18cd615-912a-4853-bb2e-225960cfe08b	2024-12-12	Warnings	Exact identifier application number: M008
Topcare Ultra Strength Stomach Relief	BISMUTH SUBSALICYLATE	Topco Associates, LLC	908da10c-2ed1-4917-a98b-bab63d7990d4	2024-12-09	Warnings	Exact identifier application number: M008
Careone Stomach Relief	BISMUTH SUBSALICYLATE	Retail Business Services, LLC.	214f64c9-29e4-353d-e063-6294a90a12b4	2024-11-26	Warnings	Exact identifier application number: M008
Anti-Diarrheal	BISMUTH SUBSALICYLATE	Lil' Drug Store Products, Inc.	079901b3-393b-44f0-85c9-2d8911f2a42a	2024-11-25	Warnings	Exact identifier application number: M008
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	e91ed8a1-0d45-402c-9c16-1ae72e695a37	2024-11-20	Warnings	Exact identifier application number: M008
Rapidol Stomach Relief	BISMUTH SUBSALICYLATE	Pharmadel LLC	efba1aea-f468-4f63-e053-2995a90a545b	2024-11-18	Warnings	Exact identifier application number: M008
RITE AID Regular Strength Pink Bismuth	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	48fe12a5-5ff0-4d35-8708-675de32a9ed0	2024-10-31	Warnings	Exact identifier application number: M008
Rite Aid Digestive Relief	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	816c4ec4-46d1-4e8e-ad91-a11946c48769	2024-10-30	Warnings	Exact identifier application number: M008
Rite Aid Stomach Relief	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	e3d49cf7-922f-438f-bc62-487a9e4db025	2024-10-30	Warnings	Exact identifier application number: M008
Rite Aid Stomach Relief Original Flavor	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	5db6ad20-208e-4881-90fc-672762f70cca	2024-10-30	Warnings	Exact identifier application number: M008
Rite Aid Regular Strngth Pink Bismuth	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	2c4acea0-dfa2-422d-a13f-17699de747e6	2024-10-30	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