Childrens Day Time Cold and Cough

Product NDC
63941-378
Requested package NDC
63941-378-04
11-digit product format
639410378
Labeler code
63941
Product ID
63941-378_d7373e58-f884-4bfe-95d4-a015fa28e226
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-31
Marketing end
2021-12-31
Substance
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
3 mg/5mL; mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63941-37863941-378-04DDiscontinued 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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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 INGREDIENT9D2RTI9KYHCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-378-04639410378041 BOTTLE in 1 BOX (63941-378-04) > 118 mL in 1 BOTTLE1 bottle2014-07-312021-12-31NoNoCurrent