Quality Choice Multi-Symptom, Non-Drowsy DayTime Cold and Flu

Product NDC
63868-386
11-digit product format
638680386
Labeler code
63868
Product ID
63868-386_387e9aff-d176-4f56-a63b-10c2be7f5b15
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-11-08
Marketing end
2020-12-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 productproduct63868-386DDiscontinued by firm2026-10-12
excluded packagepackage63868-38663868-386-24DDiscontinued 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 · 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 packagepackage63868-386-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-386-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-386-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-386-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-386-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-386-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-386-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-386-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-386-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-386-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-386-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-386-24557ba5c1ecfa…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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8QUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
GELATININACTIVE INGREDIENT2G86QN327LQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9QUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
SORBITANINACTIVE INGREDIENT6O92ICV9RUQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
SORBITOLINACTIVE INGREDIENT506T60A25RQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE MULTI-SYMPTOM, NON-DROWSY DAYTIME COLD AND FLU (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3