Maximum strength Stomach Relief

Product NDC: 67091-234
11-digit product format: 670910234
Labeler code: 67091
Product ID: 67091-234_61b94eed-aada-4453-8659-4d9f57705d0b
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth Subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: WinCo Foods, LLC
Application: part335
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-12-12
Marketing end: 0000-00-00
Substance: BISMUTH SUBSALICYLATE
Active strength: 525 mg/15mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67091-234		I	Inactivated by FDA		2026-10-05
excluded package	package	67091-234	67091-234-23	I	Inactivated by FDA		2026-10-05

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 · 42 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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`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	67091-234-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67091-234-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67091-234-23	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67091-234-23	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67091-234-23	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67091-234-23	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67091-234-23	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67091-234-23	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67091-234-23	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67091-234-23	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67091-234-23	2020-01-31	C162847	48780-1	9d75b9d0-be7e-f424-e053-dadaa90a57ce	Maximum Strength Stomach Relief Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67091-234-23	Maximum strength Stomach Relief	236 mL in 1 BOTTLE	LIQUID	236		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISMUTH SUBSALICYLATE	ACTIVE INGREDIENT	62TEY51RR1	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
BISMUTH CATION	ACTIVE MOIETY	ZS9CD1I8YE	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-234	MAXIMUM STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [WINCO FOODS, LLC]	1	Legacy NDC, 1 package rows	20141212_f3323f03-eea3-49cf-acef-66873ae0eef2.zip

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
308763	bismuth subsalicylate 1050 MG in 30 mL Oral Suspension	PSN	f3323f03-eea3-49cf-acef-66873ae0eef2	1
308763	bismuth subsalicylate 35 MG/ML Oral Suspension	SCD	f3323f03-eea3-49cf-acef-66873ae0eef2	1
308763	bismuth subsalicylate 1050 MG per 30 ML Oral Suspension	SY	f3323f03-eea3-49cf-acef-66873ae0eef2	1
308763	bismuth subsalicylate 525 MG per 15 ML Oral Suspension	SY	f3323f03-eea3-49cf-acef-66873ae0eef2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67091-234-23	67091023423	236 mL in 1 BOTTLE	236 ml	Historical