Gastrobiz

Product NDC: 69168-999
11-digit product format: 691680999
Labeler code: 69168
Product ID: 69168-999_b84b5c7b-afd7-4d0c-8db6-eda1bf813a75
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Allegiant Health
Application: M008
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-07-04
Substance: BISMUTH SUBSALICYLATE
Active strength: 262 mg/1
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: Gastrobiz
Listing expiration: 2027-12-31

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
aa516512-afd7-453f-9c73-5fa930cafac3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69168-999-98	2020-03-13	C162847	48780-1	9d75b9d0-38d1-f424-e053-dadaa90a57ce	Gastrobiz Bismuth Subsalicylate 262mg
69168-999-98	2020-01-31	C162847	48780-1	9d75b9d0-38d1-f424-e053-dadaa90a57ce	Gastrobiz Bismuth Subsalicylate 262mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-999-98	Gastrobiz	1 in 1 CELLO PACK	TABLET, CHEWABLE	1		9
69168-999-98	Gastrobiz	30 in 1 CARTON	TABLET, CHEWABLE	30		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-999	GASTROBIZ (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]	8	Current NDC, Legacy NDC, 2 package rows	20241206_aa516512-afd7-453f-9c73-5fa930cafac3.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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	P & L Development, LLC	7a461b91-d11f-4cb9-be61-c7d91d278302	2024-04-16	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Gobrands, Inc. (Goodnow)	cd647eb7-6e03-415c-8249-89c126824d00	2024-04-03	Warnings	Exact identifier application number: M008
Stomach Relief Ultra Strength	BISMUTH SUBSALICYLATE	Care One (Retail Business Services, LLC.)	c443b640-18b0-4b7d-a13c-0accb915a801	2024-03-05	Warnings	Exact identifier application number: M008
Stomach Relief - Regular Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	970b4118-2c2e-4806-8fe8-937ba06cf6e9	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief, Maximum Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	cdd436f6-b769-49aa-9e6c-da512da9e6e3	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief - Maximum Strength	BISMUTH SUBSALICYLATE	AptaPharma Inc.	15cd9163-16d6-4332-9e26-77c05e0a26a7	2023-12-30	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Demoulas Super Markets Inc	9a95d198-f3ba-4bc3-a6f1-e065eb7e86f0	2023-12-29	Warnings	Exact identifier application number: M008
Stomach Relief Maximum Strength	BISMUTH SUBSALICYLATE	Demoulas Super Markets Inc	b2d55045-d4a4-4167-a20c-42932f35bab2	2023-12-29	Warnings	Exact identifier application number: M008
STOMACH RELIEF	BISMUTH SUBSALICYLATE	Consumer Value Products, Inc.	7526a3f2-ce7c-46c8-8ddf-1bcaf313876d	2023-12-29	Warnings	Exact identifier application number: M008
Estomaquil Polvo	BISMUTH SUBSALICYLATE	ProMex LLC	cf94c99a-c489-45ec-bb13-3e6959e377de	2023-11-29	Warnings	Exact identifier application number: M008
Stomach Relief Regular Strength	BISMUTH SUBSALICYLATE	Care One (Retail Business Services, LLC.)	3c53adaa-275f-4164-b21e-285e4f03433e	2023-10-05	Warnings	Exact identifier application number: M008
Pepto-Bismol Chewable, TRAVEL BASIX	BISMUTH SUBSALICYLATE	Lil' Drug Store Products, Inc.	dd2f2205-34d1-4960-bf37-bb8d534cd0e1	2023-10-03	Warnings	Exact identifier application number: M008
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 ndc (product): 69168-999
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308761	bismuth subsalicylate 262 MG Chewable Tablet	PSN	aa516512-afd7-453f-9c73-5fa930cafac3	9
308761	bismuth subsalicylate 262 MG Chewable Tablet	SCD	aa516512-afd7-453f-9c73-5fa930cafac3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-999-98	69168099998	30 CELLO PACK in 1 CARTON (69168-999-98) / 1 TABLET, CHEWABLE in 1 CELLO PACK	30 cello pack	2022-06-30	0000-00-00	No	No	Current