Stomach Relief

Product NDC
36800-045
Requested package NDC
36800-045-16
11-digit product format
368000045
Labeler code
36800
Product ID
36800-045_e7c95bee-0b3c-4f69-9fb6-1ebbbdacfd78
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-28
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-04536800-045-16DDiscontinued by firm2026-10-05

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
METHYLCELLULOSE (1500 MPA.S)INACTIVE INGREDIENTP0NTE48364STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4STOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOMACH RELIEF REGULAR STRENGTH (BISMUTH SUBSALICYLATE) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-045-1636800004516473 mL in 1 BOTTLE, PLASTIC (36800-045-16) 473 ml2015-02-280000-00-00NoNoCurrent