Bismuth Subsalicylate

Product NDC: 81033-046
11-digit product format: 810330046
Labeler code: 81033
Product ID: 81033-046_5b126fca-aaea-4d57-e063-6394a90aafb5
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: Kesin Pharma
Application: M008
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-02-03
Substance: BISMUTH SUBSALICYLATE
Active strength: 525 mg/30mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Bismuth Subsalicylate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISMUTH SUBSALICYLATE	525 mg/30mL

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
308762	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
5b126fca-aae9-4d57-e063-6394a90aafb5	Available on FDA.report

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 10 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stomach Relief	BISMUTH SUBSALICYLATE	CDMA- QC	fe3cd0ce-933b-4ad3-a34f-c057a9356158	2021-06-16	Warnings	Exact identifier application number: M008
Topcare Stomach Relief Original Strength	BISMUTH SUBSALICYLATE	TopCo Associates, LLC	e4b1929c-0967-44ea-8552-6549aa2a464e	2018-12-14	Warnings	Exact identifier application number: M008
Bismuth	BISMUTH SUBSALICYLATE	Allegiant Health	015ca07a-f6b5-4741-a7b0-821cf6d4e418	2018-11-07	Warnings	Exact identifier application number: M008
Gastrobiz	BISMUTH SUBSALICYLATE	Allegiant Health	aa516512-afd7-453f-9c73-5fa930cafac3	2018-09-11	Warnings	Exact identifier application number: M008
Pep Tum	BISMUTH SUBSALICYLATE	First Aid Direct	bf966e9f-2f95-41cd-a6e5-b8eb521181d8	2017-12-22	Warnings	Exact identifier application number: M008
Bismuth Chewable	BISMUTH SUBSALICYLATE 262 MG	Marc Glassman, Inc.	cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e	2016-12-19	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	Marketing start	Sample	Exclude flag	Status
81033-046-34	81033004634	30 CUP, UNIT-DOSE in 1 CARTON (81033-046-34) / 15 mL in 1 CUP, UNIT-DOSE (81033-046-15)	2026-09-09	No	No	Current