FDA.reportPublic FDA data

Digestive Relief

Product NDC
46994-372
11-digit product format
469940372
Labeler code
46994
Product ID
46994-372_9b8ade31-231a-4e63-a936-f06126af2546
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Being Well
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-08-30
Marketing end
2023-10-27
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46994-372DDiscontinued by firm2026-07-31
excluded packagepackage46994-37246994-372-08DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFIf2ef3cc3-4628-4e55-ad55-4887b203c5b22024-05-13WarningsExact identifier
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFIa5767e55-97cc-4fe4-a431-668635e205af2024-05-12WarningsExact identifier
QCH Stomach Relief 535BISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.e85bb0cc-458d-4186-ad1f-6c23ec03d7312024-04-19WarningsExact identifier
Quality Choice Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.61aaa192-d2eb-4786-a10f-47d612643f152024-04-18WarningsExact identifier
Family wellness Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar Services, Inc.16cca659-33e9-42b1-ad7e-583f4a9a2fd52024-02-12WarningsExact identifier
Guardian Pink-Bismuth CherryBISMUTH SUBSALICYLATEGuardian Drug Companyfe632563-c3de-4214-b41d-4e7a1fbfcf592023-12-04WarningsExact identifier
Pepto ReliefBISMUTH SUBSALICYLATEAdvance Pharmaceutical Inc.a02babe7-9255-44c7-90e1-b5ad5e59c72a2017-12-22WarningsExact identifier
Stomach ReliefBISMUTH SUBSALICYLATECVS PHARMACY, INC.65dbe287-4528-4dbd-9116-6d4812fd4fa22017-11-28WarningsExact identifier
Stomach ReliefBISMUTH SUBSALICYLATEPuraCap Pharmaceutical LLC01a4782f-93af-4d30-8ca3-7b39c272f60e2017-11-28WarningsExact identifier
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
Stomach reliefBISMUTH SUBSALICYLATECVS53cf4590-a625-42f7-bd03-8401d08b64472017-08-08WarningsExact identifier
Maximum strength Stomach ReliefBISMUTH SUBSALICYLATECVS75326a55-7cf3-411e-96a3-a6aef6c35ca52017-08-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46994-372-082022-10-10C16284748780-1d6a99b39-364c-a426-e053-dadaa90af4c2Drug Facts
46994-372-082022-01-28C16284748780-1d6a99b39-364c-a426-e053-dadaa90af4c2Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46994-372-0846994037208237 mL in 1 BOTTLE, PLASTIC (46994-372-08) 237 ml2019-08-300000-00-00NoNoCurrent