FDA.reportPublic FDA data

Tussin DM

Product NDC
37808-359
Requested package NDC
37808-359-40
11-digit product format
378080359
Labeler code
37808
Product ID
37808-359_d1da766f-79d9-4fd6-a228-757aea65465d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1991-08-09
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 packagepackage37808-35937808-359-40DDiscontinued 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 · 9 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…

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
37808-359-26ML - Milliliter37808-359888f8e17-e671-4467-a52f-6764f960a86512022-06-06
37808-359-34ML - Milliliter37808-3595be83819-35db-419c-bcf5-2ccf21aca14112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [H E B]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-359-40378080359401 BOTTLE in 1 CARTON (37808-359-40) > 355 mL in 1 BOTTLE1 bottle2002-09-200000-00-00NoNoCurrent