Adults Tussin DM

Product NDC
37012-359
11-digit product format
370120359
Labeler code
37012
Product ID
37012-359_b60113a1-739f-4c47-9cb6-68d6c2a72ffb
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-07-08
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37012-359DDiscontinued by firm2026-10-12
excluded packagepackage37012-35937012-359-34DDiscontinued 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 · 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 packagepackage37012-359-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-359-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-359-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-359-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-359-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-359-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-359-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-359-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-359-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-359-34ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-359-34367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-359-34557ba5c1ecfa…9c80585c8c6e…

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
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
GUAIFENESINACTIVE INGREDIENT495W7451VQADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
GUAIFENESINACTIVE MOIETY495W7451VQADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3AADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RADULTS TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [SHOPKO STORES OPERATING CO., LLC]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-359-34370120359341 BOTTLE in 1 CARTON (37012-359-34) > 237 mL in 1 BOTTLE1 bottle2013-07-080000-00-00NoNoCurrent