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 8 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

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