MUCUS RELIEF DM

Product NDC
0904-6233
11-digit product format
009046233
Labeler code
0904
Product ID
0904-6233_01e42400-14bd-4f5d-a423-8a01d9b1105c
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN, DEXTROMETHORPHAN HBr
Dosage form
TABLET
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-23
Marketing end
2020-02-29
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400 mg/1; mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6233DDiscontinued by firm2026-11-10
excluded packagepackage0904-62330904-6233-46DDiscontinued by firm2026-11-10
excluded packagepackage0904-62330904-6233-52DDiscontinued by firm2026-11-10

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 · 36 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 packagepackage0904-6233-52d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6233-46d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6233-52f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6233-46f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6233-522ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6233-462ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6233-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6233-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6233-52cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6233-46cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6233-52cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6233-46cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6233-52302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6233-46302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6233-52ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6233-46ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6233-520efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6233-460efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6233-52ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6233-46ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6233-52367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6233-46367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6233-52557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6233-46557ba5c1ecfa…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
0904-6233-46EA - Each0904-62332bbb1c02-d703-43e6-8bfa-7670c6162ae112013-02-13
0904-6233-52EA - Each0904-6233ba1fbef3-f769-4bca-befa-cc625196e33312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1