harmon face values tussin cf

Product NDC
63940-516
11-digit product format
639400516
Labeler code
63940
Product ID
63940-516_de6a375f-25e1-411b-bfd7-9860e07da4fa
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Harmon Stores Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-18
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/10mL; 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 productproduct63940-516DDiscontinued by firm2026-10-05
excluded packagepackage63940-51663940-516-34DDiscontinued by firm2026-10-05

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 packagepackage63940-516-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63940-516-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63940-516-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63940-516-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63940-516-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63940-516-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63940-516-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63940-516-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63940-516-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63940-516-34ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63940-516-34367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63940-516-34557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4HARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHARMON FACE VALUES TUSSIN CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [HARMON STORES INC.]2