Stomach Relief

Product NDC
55319-371
11-digit product format
553190371
Labeler code
55319
Product ID
55319-371_beaaf168-0fab-48b3-8bea-f324a4fb70fc
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-31
Marketing end
2025-01-31
Substance
BISMUTH SUBSALICYLATE
Active strength
1050 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#

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-371DDiscontinued by firm2026-10-12
excluded packagepackage55319-37155319-371-08DDiscontinued by firm2026-10-12

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-371-08DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-371-08DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-371-08DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-371-08DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-371-08DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-371-08DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-371-08IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-371-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-371-08IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-371-082022-10-31C16284748780-1d6a99b39-d2ec-a426-e053-dadaa90af4c2Drug Facts
55319-371-082022-01-28C16284748780-1d6a99b39-d2ec-a426-e053-dadaa90af4c2Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1STOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
METHYLCELLULOSE (1500 MPA.S)INACTIVE INGREDIENTP0NTE48364STOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
WATERINACTIVE INGREDIENT059QF0KO0RSTOMACH RELIEF MAXIMUM STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-371-0855319037108237 mL in 1 BOTTLE, PLASTIC (55319-371-08) 237 ml2014-12-312025-01-31NoNoCurrent