Major Bismuth Subsalicylate

Product NDC: 0904-7205
11-digit product format: 009047205
Labeler code: 0904
Product ID: 0904-7205_61f89479-7da0-4f57-b505-d7ad3c2c52cb
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M008
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-10-11
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Major Bismuth Subsalicylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISMUTH SUBSALICYLATE	262 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
62TEY51RR1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308761	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2a7c9cc1-206e-4018-b89d-7b634df43df6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7205-46	Major Bismuth Subsalicylate	5 in 1 BOX	TABLET, CHEWABLE	5		4
0904-7205-46	Major Bismuth Subsalicylate	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7205-46	EA - Each	0904-7205	95b361d5-4a5c-4320-82e3-5e1d2ee5479d	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7205	MAJOR BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20241206_2a7c9cc1-206e-4018-b89d-7b634df43df6.zip

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 9 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RITE AID Ultra Strnght Pink Bismuth	BISMUTH SUBSALICYLATE	RITE AID CORPORATION	3ffb2bb9-6d6a-4c38-ac59-0ac0d754de28	2024-10-30	Warnings	Exact identifier application number: M008
Premier Value Diarrhea Relief Vanilla Flavor	BISMUTH SUBSALICYLATE	PHARMACY VALUE ALLIANCE, LLC	1c6e464c-d5c6-4658-a0d8-bba87369a0c3	2024-10-28	Warnings	Exact identifier application number: M008
Premier Value	BISMUTH SUBSALICYLATE	CHAIN DRUG CONSORTIUM,LLC	3b8850e8-f9c2-4d52-aadd-8e037fabdee4	2024-10-28	Warnings	Exact identifier application number: M008
Goodsense maximum strength Stomach Relief 528	BISMUTH SUBSALICYLATE	Good Sense (Geiss, Destin & Dunn, Inc.)	19a4191a-6196-f8ac-e063-6394a90a47ab	2024-09-17	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Best Choice (Valu Merchandisers Company)	5ecc500c-12d0-41dd-acb4-9190023c9ed5	2024-09-16	Warnings	Exact identifier application number: M008
Stomach Relief Ultra	BISMUTH SUBSALICYLATE	Best Choice (Valu Merchandisers Company)	ecbf9caf-b02b-434e-8f29-50839010e821	2024-09-16	Warnings	Exact identifier application number: M008
Goodsense Regular strength Stomach Relief 122	BISMUTH SUBSALICYLATE	Good Sense (Geiss, Destin & Dunn, Inc.)	19a324bd-fa54-b899-e063-6394a90aaa73	2024-09-10	Warnings	Exact identifier application number: M008
Ultra Bismuth	BISMUTH SUBSALICYLATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0fc01a1a-4b1d-4c78-9955-220984a8019c	2024-08-30	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	b22e1a0f-9866-403b-93e8-6e0e4130a75e	2024-08-29	Warnings	Exact identifier application number: M008
Stomach Relief Ultra	BISMUTH SUBSALICYLATE	Rugby Laboratories, Inc.	87394088-1d2e-4ca4-bbfe-1481c9d4a3ba	2024-08-29	Warnings	Exact identifier application number: M008
Soothe	BISMUTH SUBSALICYLATE	Walgreens	a2b2b0ce-034e-4857-bfca-0087bb31878e	2024-07-25	Warnings	Exact identifier application number: M008
5-Symptom Digestive Relief	BISMUTH SUBSALICYLATE	TARGET CORPORATION	07aa10e2-dd03-f32d-e063-6294a90aad0d	2024-06-26	Warnings	Exact identifier application number: M008
Stomach Relief	STOMACH RELIEF	Chain Drug Marketing Association, Inc.	459abf99-63e8-43d7-a13c-9e4682698415	2024-06-21	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Strategic Sourcing Services LLC	2a018350-da22-4997-9181-661bb920afd3	2024-06-04	Warnings	Exact identifier application number: M008
5 Symptom Digestive Relief	BISMUTH SUBSALICYLATE	TARGET CORPORATION	07a932fb-38eb-4b35-e063-6394a90ad61f	2024-05-25	Warnings	Exact identifier application number: M008
Soothe Ultra Strength	BISMUTH SUBSALICYLATE	Walgreens	ec96e6f2-b087-457e-9b95-30f3595deebb	2024-05-21	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Safeway, Inc.	2bde4e41-ffbd-4d9d-ae00-e39a5c7264b3	2024-05-15	Warnings	Exact identifier application number: M008
Ultra Stomach Relief	BISMUTH SUBSALICYLATE	Safeway, Inc.	71ca1c0e-50dc-4970-ae0d-5f7be1eec6df	2024-05-15	Warnings	Exact identifier application number: M008
PEPT-ACHE	BISMUTH SUBSALICYLATE	JHK Inc dba American Safety & First Aid	894c1912-cd24-4ddf-b7e7-dae9dd64b280	2024-04-24	Warnings	Exact identifier application number: M008
Stomach Relief Ultra Strength	BISMUTH SUBSALICYLATE	P & L Development, LLC	cb5ca7ab-39cf-4b07-ac22-a00b214db102	2024-04-16	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
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	2a7c9cc1-206e-4018-b89d-7b634df43df6	4
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	69b9999f-c2e5-43a6-891f-0e24d3c343a4	4
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	2a7c9cc1-206e-4018-b89d-7b634df43df6	4
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	69b9999f-c2e5-43a6-891f-0e24d3c343a4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7205-46	00904720546	5 BLISTER PACK in 1 BOX (0904-7205-46) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	5 blister pack	2021-10-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Bismuth Subsalicylate	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN OTC DRUG LABEL	4
Major Bismuth Subsalicylate	Major Pharmaceuticals \| Guardian Drug Company	2025-07-11	Human OTC Drug Label	4