Tussin Cough and Chest Congestion DM

Product NDC
15127-085
11-digit product format
151270085
Labeler code
15127
Product ID
15127-085_0ba663a1-6449-43d2-869a-b9eed99bcd15
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Select Brand Dist.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-31
Marketing end
2021-12-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
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 productproduct15127-085DDiscontinued by firm2026-08-11
excluded packagepackage15127-08515127-085-04DDiscontinued by firm2026-08-11
excluded packagepackage15127-08515127-085-08DDiscontinued by firm2026-08-11

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 packagepackage15127-085-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage15127-085-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage15127-085-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage15127-085-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage15127-085-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage15127-085-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage15127-085-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage15127-085-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage15127-085-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage15127-085-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage15127-085-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage15127-085-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage15127-085-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage15127-085-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage15127-085-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage15127-085-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage15127-085-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage15127-085-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage15127-085-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage15127-085-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage15127-085-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage15127-085-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage15127-085-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage15127-085-08557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
SUCROSEINACTIVE INGREDIENTC151H8M554TUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN COUGH AND CHEST CONGESTION DM ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15127-085-04151270085041 BOTTLE, PLASTIC in 1 BOTTLE (15127-085-04) > 118 mL in 1 BOTTLE, PLASTIC2015-03-312021-12-30NoNoCurrent
15127-085-08151270085081 BOTTLE, PLASTIC in 1 BOX (15127-085-08) > 237 mL in 1 BOTTLE, PLASTIC2015-03-312021-12-30NoNoCurrent