FDA.reportPublic FDA data

Tussin DM

Product NDC
59779-359
11-digit product format
597790359
Labeler code
59779
Product ID
59779-359_b13de402-d995-4a12-902c-46478992d882
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1991-09-24
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-359DDiscontinued by firm2026-10-16
excluded packagepackage59779-35959779-359-26DDiscontinued by firm2026-10-16
excluded packagepackage59779-35959779-359-34DDiscontinued by firm2026-10-16
excluded packagepackage59779-35959779-359-40DDiscontinued by firm2026-10-16

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 · 42 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 packagepackage59779-359-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-359-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-359-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-359-34f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-359-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-359-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-359-342ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-359-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-359-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-359-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-359-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-359-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-359-34cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-359-26cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-359-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-359-34cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-359-26cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-359-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-359-34302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-359-26302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-359-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-359-34ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-359-26ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-359-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-359-340efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-359-260efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-359-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-359-34ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-359-26ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-359-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-359-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-359-40557ba5c1ecfa…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
59779-359-26ML - Milliliter59779-359d6b0e99e-ef4e-466e-82a0-f0a1499aa8da12017-11-06
59779-359-34ML - Milliliter59779-359fe4eeec9-9b11-4c43-a883-eeedb7ebf26a12018-06-11
59779-359-40ML - Milliliter59779-359b568677c-9fef-4cea-b1ac-d68d122fc2f712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM ADULT COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CVS PHARMACY]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-359-26597790359261 BOTTLE in 1 CARTON (59779-359-26) > 118 mL in 1 BOTTLE1 bottle1996-05-100000-00-00NoNoCurrent
59779-359-34597790359341 BOTTLE in 1 CARTON (59779-359-34) > 237 mL in 1 BOTTLE1 bottle1991-09-240000-00-00NoNoCurrent
59779-359-40597790359401 BOTTLE in 1 CARTON (59779-359-40) > 355 mL in 1 BOTTLE1 bottle1993-04-140000-00-00NoNoCurrent