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 3 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kaopectate	BISMUTH SUBSALICYLATE	Kramer Laboratories	3877a88d-9546-48ce-ad6b-3c2a115e3eaf	2026-06-03	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate Suspension Regular Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	f0976d6c-d574-49e8-b98a-23a660d83fa0	2026-06-02	Warnings	Exact identifier application number: M008
Stomach Relief Maximum Strength	BISMUTH SUBSALICYLATE	CVS Pharmacy	9d8f2456-732d-40bf-a10c-98423560c029	2026-05-13	Warnings	Exact identifier application number: M008
Green Guard Instydose Upset Stomach Relief	BISMUTH SUBSALICYLATE	Unifirst First Aid Corporation	5b1f31a9-8eec-4c3d-e063-6394a90a2efe	2026-05-01	Warnings	Exact identifier application number: M008
Stomach Relief Ultra	BISMUTH SUBSALICYLATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	6f189c12-eb94-476e-a8f7-ea82f44c4aa5	2026-04-13	Warnings	Exact identifier application number: M008
Pepto Bismol	BISMUTH SUBSALICYLATE	Navajo Manufacturing Company Inc.	033bccc6-6e81-487f-91fe-9d7cc465e1b2	2026-04-08	Warnings	Exact identifier application number: M008
Soothe	BISMUTH SUBSALICYLATE	Walgreens	450483c3-487f-4a8f-a439-5661241a8f0f	2026-04-08	Warnings	Exact identifier application number: M008
GS Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Good Sense (Geiss, Destin & Dunn, Inc.)	edd15c7d-f66b-4b1a-8cda-9814a3790483	2026-03-31	Warnings	Exact identifier application number: M008
WALGREEN ULTRA STRENGTH PINK BISMUTH	BISMUTH SUBSALICYLATE	WALGREENS CO.	d0f78754-2556-4aa8-949b-a6e3b4adf8c2	2026-03-25	Warnings	Exact identifier application number: M008
Dr. Simi Stomach Relief	BISMUTH SUBSALICYLATE 525 MG	Farmacias De Similares TX LLC	4dc9233e-68fb-e1e8-e063-6294a90aee33	2026-03-24	Warnings	Exact identifier application number: M008
Major Bismuth Subsalicylate	BISMUTH SUBSALICYLATE	Preferred Pharmaceuticals Inc.	69b9999f-c2e5-43a6-891f-0e24d3c343a4	2026-03-20	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Grocery Outlet, Inc.	4465dd17-c333-7b95-e063-6294a90a5053	2026-03-19	Warnings	Exact identifier application number: M008
AMAZON Regular Strength	BISMUTH SUBSALICYLATE	AMAZON.COM SERVICES LLC	6b41f36d-1810-45f7-a46c-67b9bff23738	2026-03-04	Warnings	Exact identifier application number: M008
AMAZON Digestive Relief	BISMUTH SUBSALICYLATE	AMAZON.COM SERVICES LLC	a9a676d8-06b9-43bf-9c06-08670c9ab211	2026-03-04	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Wal-Mart Stores Inc	2d7d563e-4c46-4788-b6a7-5b92e3d58533	2026-02-26	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Chain Drug Marketing Association, Inc.	d63110ee-2d64-46dd-80bf-696c9b9d8d7c	2026-02-26	Warnings	Exact identifier application number: M008
SIGNATURE CARE Ultra Strength Stomach	BISMUTH SUBSALICYLATE	SAFEWAY	4b54fa21-d8ea-4497-aa32-17e47669c8e1	2026-02-20	Warnings	Exact identifier application number: M008
SIGNATURE CARE Regular Strength	BISMUTH SUBSALICYLATE	SAFEWAY	b4643d99-90ce-4f00-a61a-a5371fe0f424	2026-02-20	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Grocery Outlet, Inc.	44673b4f-1bf8-9db3-e063-6294a90a62f5	2026-02-14	Warnings	Exact identifier application number: M008
Treda Ultra	BISMUTH SUBSALICYLATE	Laboratorios Sanfer, S.A. de C.V.	cfa7f37a-e18b-4929-b3a4-4126b0aa679a	2026-02-12	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

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