Adults Tussin DM

Product NDC
37012-359
Requested package NDC
37012-359-34
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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 · 12 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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