Stomach Relief

Product NDC
49348-922
11-digit product format
493480922
Labeler code
49348
Product ID
49348-922_d900e271-bb6c-4d41-8887-e8bd3b061993
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-31
Marketing end
2020-12-31
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
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 productproduct49348-922DDiscontinued by firm2026-10-05
excluded packagepackage49348-92249348-922-37DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-922-37d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-922-37f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-922-372ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-922-37a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-922-37cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-922-37cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-922-37302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-922-37ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-922-370efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-922-37ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-922-37367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-922-37557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-922-37ML - Milliliter49348-922ccebcbf5-4df6-4af3-9901-1daa6979adb112015-03-03

DailyMed Socrata Ingredients#

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