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 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

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