Stomach Relief

Product NDC: 49580-0842
11-digit product format: 495800842
Labeler code: 49580
Product ID: 49580-0842_2098abda-1027-4fc4-b273-2a0f39316a41
Type: HUMAN OTC DRUG
Nonproprietary name: Bismuth subsalicylate
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: M008
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-28
Substance: BISMUTH SUBSALICYLATE
Active strength: 525 mg/15mL
Pharmacologic classes: Bismuth [CS], Bismuth [EPC]
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: Stomach Relief
Brand name suffix: Ultra Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISMUTH SUBSALICYLATE	525 mg/15mL

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
308763	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
cb5ca7ab-39cf-4b07-ac22-a00b214db102	Available on FDA.report

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
49580-0842-8	2023-06-01	C162847	48780-1	f386c649-e414-0266-e053-dadaa90a7c1a	Drug Facts
49580-0842-8	2023-01-30	C162847	48780-1	f386c649-e414-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49580-0842-8	Stomach ReliefUltra Strength	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0842	STOMACH RELIEF ULTRA STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [P & L DEVELOPMENT, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240418_cb5ca7ab-39cf-4b07-ac22-a00b214db102.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 7 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Revasol Peptic Relief	BISMUTH SUBSALICYLATE	Rnv LLC	30dc3a0a-3496-4bdf-e063-6394a90a62fd	2025-03-21	Warnings	Exact identifier application number: M008
TopCare Bismuth Stomach Relief	BISMUTH	TopCo	308f4b2a-22ff-42b9-e063-6394a90acc75	2025-03-17	Warnings	Exact identifier application number: M008
Ultra Strength Stomach Relief	BISMUTH SUBSALICYLATE	Guardian Drug Company	25175eac-d15f-ce0d-e063-6394a90a0650	2025-03-10	Warnings	Exact identifier application number: M008
Pink Bismuth Regular Strength	BISMUTH SUBSALICYLATE	Discount Drug Mart, Inc	2e0c675e-72ce-4a22-e063-6394a90a3dff	2025-02-27	Warnings	Exact identifier application number: M008
Pink Bismuth	BISMUTH SUBSALICYLATE	Discount Drug Mart, Inc	2e0ce5dd-9eb5-8568-e063-6394a90a1a29	2025-02-27	Warnings	Exact identifier application number: M008
Maximum Strength Pink Bismuth	BISMUTH SUBSALICYLATE	Discount Drug Mart, Inc	2e0d4508-e5a1-ba46-e063-6394a90aec2a	2025-02-27	Warnings	Exact identifier application number: M008
Pink Bismuth Original	BISMUTH SUBSALICYLATE 525 MG	Discount Drug Mart, Inc	2e0cb7d7-4c4f-824a-e063-6394a90aa3a4	2025-02-27	Warnings	Exact identifier application number: M008
SIMETHICONE	SIMETHICONE	NuCare Pharmaceuticals,Inc.	e07f6acc-1b75-d8eb-e053-2a95a90a7d9b	2025-02-24	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	Harris Teeter, LLC	2c51458b-869c-0283-e063-6394a90a4ff7	2025-02-12	Warnings	Exact identifier application number: M008
Max Strength Stomach Relief	BISMUTH SUBSALICYLATE	Harris Teeter, LLC	2c516139-0a6a-5ba6-e063-6394a90aa14a	2025-02-12	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate	BISMUTH SUBSALICYLATE	LEADER/ Cardinal Health 110, Inc.	d4af6694-910c-da17-e053-2995a90a8454	2025-02-11	Warnings	Exact identifier application number: M008
Regular Strength Stomach Relief	BISMUTH SUBSALICYLATE	DOLGENCORP, INC.	f2ec112f-213c-8a23-e053-2995a90a5f3f	2025-02-10	Warnings	Exact identifier application number: M008
Maximum Strength Stomach Relief	BISMUTH SUBSALICYLATE	Guardian Drug Company	af899b52-7d8c-4485-9fb8-006dae53568a	2025-02-10	Warnings	Exact identifier application number: M008
CVS Health Stomach Relief SOFTGEL	BISMUTH SUBSALICYLATE	CVS Pharmacy, Inc.	273013b3-9f79-873d-e063-6394a90a6640	2025-01-24	Warnings	Exact identifier application number: M008
GNP Pink Bismuth	BISMUTH SUBSALICYLATE	Amerisource Bergen	9f5df648-298a-43e3-b250-8db6786fc93f	2025-01-20	Warnings	Exact identifier application number: M008
Bismuth Subsalicylate 262 mg	BISMUTH SUBSALICYLATE	Reliable 1 Laboratories LLC	2e40ffd8-1afa-43af-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M008
Equate Stomach Relief	BISMUTH SUBSALICYLATE	Wal-Mart Stores, Inc.	1e8ae968-6d40-4ac7-9bce-01d086584b61	2025-01-09	Warnings	Exact identifier application number: M008
Stomach Relief	BISMUTH SUBSALICYLATE	CARDINAL HEALTH 110, LLC. DBA LEADER	b38d815b-a249-46d1-a9d0-4e8efab3e56b	2025-01-06	Warnings	Exact identifier application number: M008
Quality Choice Stomach Relief 528	BISMUTH SUBSALICYLATE	Chain Drug Marketing Association Inc.	e065320d-09ee-4ab8-868a-ab3b4239e392	2025-01-03	Warnings	Exact identifier application number: M008
HEB Stomach Relief	BISMUTH SUBSALICYLATE	H E B	fac642cf-f2f7-4857-b54f-82f1dcb400ab	2024-12-26	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

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	cb5ca7ab-39cf-4b07-ac22-a00b214db102	3
308763	bismuth subsalicylate 35 MG/ML Oral Suspension	SCD	cb5ca7ab-39cf-4b07-ac22-a00b214db102	3
308763	bismuth subsalicylate 1050 MG per 30 ML Oral Suspension	SY	cb5ca7ab-39cf-4b07-ac22-a00b214db102	3
308763	bismuth subsalicylate 525 MG per 15 ML Oral Suspension	SY	cb5ca7ab-39cf-4b07-ac22-a00b214db102	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0842-8	49580084208	237 mL in 1 BOTTLE, PLASTIC (49580-0842-8)	237 ml	2019-02-28	0000-00-00	No	No	Current