Pepto-Bismol

Product NDC: 37000-476
11-digit product format: 370000476
Labeler code: 37000
Product ID: 37000-476_eea2bc33-da26-66b8-e053-2995a90aafef
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET
Route: ORAL
Labeler: The Procter & Gamble Manufacturing Company
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	37000-476		D	Discontinued by firm	2026-10-15
excluded package	package	37000-476	37000-476-01	D	Discontinued by firm	2026-10-15
excluded package	package	37000-476	37000-476-02	D	Discontinued by firm	2026-10-15
excluded package	package	37000-476	37000-476-03	D	Discontinued by firm	2026-10-15
excluded package	package	37000-476	37000-476-12	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	37000-476-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-476-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-476-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37000-476-12	`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	37000-476-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-476-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-476-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37000-476-12	`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	37000-476-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-476-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-476-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37000-476-12	`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	37000-476-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-476-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-476-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37000-476-12	`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	37000-476-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-476-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-476-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37000-476-12	`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	37000-476-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-476-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-476-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37000-476-12	`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	37000-476-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-476-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-476-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37000-476-12	`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	37000-476-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-476-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-476-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37000-476-12	`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	37000-476-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-476-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-476-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37000-476-12	`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	37000-476-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-476-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-476-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37000-476-12	`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	37000-476-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37000-476-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37000-476-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37000-476-12	`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	37000-476-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37000-476-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37000-476-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37000-476-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
37000-476-01	2021-02-12	Pepto BISMOL ® Caplets
37000-476-02	2021-02-12	Pepto BISMOL ® Caplets
37000-476-03	2021-02-12	Pepto BISMOL ® Caplets
37000-476-12	2021-02-12	Pepto BISMOL ® Caplets
37000-476-01	2021-01-29	Pepto BISMOL ® Caplets
37000-476-02	2021-01-29	Pepto BISMOL ® Caplets
37000-476-03	2021-01-29	Pepto BISMOL ® Caplets
37000-476-12	2021-01-29	Pepto BISMOL ® Caplets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37000-476-02	EA - Each	37000-476	29cf9157-f172-435e-a630-d8b504d31355	1	2015-10-02
37000-476-03	EA - Each	37000-476	f48857f1-cfc1-43b9-b962-87c1e563058f	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bismuth subsalicylate	ACTIVE INGREDIENT	62TEY51RR1	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
Bismuth subsalicylate	ACTIVE MOIETY	62TEY51RR1	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURING COMPANY]	1

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 4 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dye Free Regular Strength Stomach Relief	BISMUTH SUBSALICYLATE	Walmart Inc.	46846abe-062d-a11f-e063-6294a90a73f3	2026-02-06	Warnings	Exact identifier application number: M008
Bismuth subsalicylate	BISMUTH SUBSALICYLATE	Softgel Healthcare Pvt Ltd	18f59606-1498-bd0c-e063-6394a90a7df2	2026-01-27	Warnings	Exact identifier application number: M008
Stomach Relief, Ultra Strength	BISMUTH SUBSALICYLATE	Marc Glassman, Inc.	8e47d007-237c-45c7-88c5-83953a06e4bd	2025-12-26	Warnings	Exact identifier application number: M008
Equate Bismuth Stomach Relief Chew	BISMUTH SUBSALICYLATE	Walmart	09967ac3-0013-c6ea-e063-6294a90a38d4	2025-12-23	Warnings	Exact identifier application number: M008
Walgreens Bismuth Stomach Relief	BISMUTH SUBSALICYLATE	Walgreens	21db191a-89a4-9854-e063-6294a90adab7	2025-12-23	Warnings	Exact identifier application number: M008
Kaopectate Max Peppermint Flavor Anti Diarrheal	BISMUTH SUBSALICYLATE	Kramer Laboratories	e7218045-a593-485b-a5ba-03f3b35cbec4	2025-12-19	Warnings	Exact identifier application number: M008
Kaopectate	BISMUTH SUBSALICYLATE	Kramer Laboratories	2f6766a1-d775-40bf-a039-975ab47fcceb	2025-12-19	Warnings	Exact identifier application number: M008
Kaopectate Peppermint Flavor Anti Diarrheal	BISMUTH SUBSALICYLATE	Kramer Laboratories	0316f469-e9fa-47c3-bb20-bd4588b40bcc	2025-12-19	Warnings	Exact identifier application number: M008
Kaopectate Vanilla Flavor Anti Diarrheal	BISMUTH SUBSALICYLATE	Kramer Laboratories	3ad310c8-3dfa-4435-87bf-17f1c0a9ca45	2025-12-19	Warnings	Exact identifier application number: M008
Meijer Bismuth Stomach Relief	BISMUTH	Meijer	26a65c79-3bc1-a424-e063-6394a90a848e	2025-12-18	Warnings	Exact identifier application number: M008
Stomach Relief, 24-7 Life by 7-Eleven	BISMUTH SUBSALICYLATE TABLET TABLET, CHEWABLE	Lil' Drug Store products, Inc.	45c206c3-5fea-2d33-e063-6394a90aa10f	2025-12-12	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Rite Aid Corporation	e9f5b3c3-9585-448d-8134-2214b5d78db0	2025-12-10	Warnings	Exact identifier application number: M008
QC Stomach Relief Cherry Flavor	BISMUTH SUBSALICYLATE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	d019eef1-8817-4bd4-84cf-04fd6542ee1a	2025-12-04	Warnings	Exact identifier application number: M008
QC Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	63f191f1-b29f-4842-9d80-ac43117c2361	2025-12-04	Warnings	Exact identifier application number: M008
QC Anti Diarrheal Vanilla Regular Flavor	BISMUTH SUBSALICYLATE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	02737763-eb98-401d-942c-186c401a2d31	2025-12-04	Warnings	Exact identifier application number: M008
Pink-Bismuth	BISMUTH SUBSALICYLATE	Guardian Drug Company	cb7da2b4-5e44-488b-a6e7-362e9b06c49c	2025-12-03	Warnings	Exact identifier application number: M008
QC Pink Bismuth	BISMUTH SUBSALICYLATE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f69f5164-f227-4527-ac1c-cda213b96b25	2025-12-03	Warnings	Exact identifier application number: M008
Walgreen Stomach Relief Ultra Strength	BISMUTH SUBSALICYLATE	WALGREENS CO.	57e66873-ccbb-4ee1-bcb9-4925713793f7	2025-12-01	Warnings	Exact identifier application number: M008
Ultra Strength digestive relief	BISMUTH SUBSALICYLATE	WALGREENS CO.	756e7a47-7e14-4694-84fa-ca6396f7edcc	2025-11-26	Warnings	Exact identifier application number: M008
Walgreen	BISMUTH SUBSALICYLATE	WALGREEN COMPANY	e7878137-a640-4d48-a6d5-23975e8b064b	2025-11-25	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37000-476-01	37000047601	1 BLISTER PACK in 1 POUCH (37000-476-01) > 2 TABLET in 1 BLISTER PACK	1 blister pack	2004-06-30	0000-00-00	No	No	Current
37000-476-02	37000047602	1 BOTTLE in 1 CARTON (37000-476-02) > 24 TABLET in 1 BOTTLE	1 bottle	2004-06-30	0000-00-00	No	No	Current
37000-476-03	37000047603	1 BOTTLE in 1 CARTON (37000-476-03) > 40 TABLET in 1 BOTTLE	1 bottle	2004-06-30	0000-00-00	No	No	Current
37000-476-12	37000047612	17852 TABLET in 1 BAG (37000-476-12)	17852 tablet	2004-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pepto BISMOL ® Caplets	The Procter & Gamble Manufacturing Company	2023-10-06	HUMAN OTC DRUG LABEL	10
Pepto-Bismol Caplet	JC World Bell Wholesale Co., Inc.	2021-10-19	HUMAN OTC DRUG LABEL	4