MEDIQUE DIOTAME

Product NDC
47682-165
11-digit product format
476820165
Labeler code
47682
Product ID
47682-165_da429631-9ba3-e695-e053-2995a90a52ad
Type
HUMAN OTC DRUG
Nonproprietary name
bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Unique First Aid Corporation
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-05
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47682-165DDiscontinued by firm2026-10-05
excluded packagepackage47682-16547682-165-71DDiscontinued 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 packagepackage47682-165-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47682-165-71f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47682-165-712ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47682-165-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47682-165-71cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47682-165-71cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47682-165-71302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47682-165-71ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47682-165-710efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47682-165-71ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage47682-165-71367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage47682-165-71557ba5c1ecfa…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
47682-165-71ML - Milliliter47682-165b01e0b46-6813-47ff-b471-bf5ca979d7c612022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1MEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RMEDIQUE DIOTAME (BISMUTH SUBSALICYLATE) SUSPENSION [UNIQUE FIRST AID CORPORATION]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-165-714768201657120 PACKET in 1 BOX (47682-165-71) > 30 mL in 1 PACKET20 packet2011-04-050000-00-00NoNoCurrent