Tussin CF

Product NDC
55312-382
11-digit product format
553120382
Labeler code
55312
Product ID
55312-382_3f59c5ab-7762-4960-83a6-8bf044effb6c
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
Dosage form
LIQUID
Route
ORAL
Labeler
Western Family Foods, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-31
Marketing end
2021-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/10mL; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55312-382DDiscontinued by firm2026-10-15
excluded packagepackage55312-38255312-382-08DDiscontinued by firm2026-10-15

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 packagepackage55312-382-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-382-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-382-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-382-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-382-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-382-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-382-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-382-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-382-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-382-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-382-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-382-08557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
LACTIC ACID, UNSPECIFIED FORMINACTIVE INGREDIENT33X04XA5ATTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI) LIQUID [WESTERN FAMILY FOODS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55312-382-08553120382081 BOTTLE, PLASTIC in 1 BOX (55312-382-08) > 237 mL in 1 BOTTLE, PLASTIC2015-08-312021-12-31NoNoCurrent