FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
63941-466
11-digit product format
639410466
Labeler code
63941
Product ID
63941-466_f1c42f29-4d42-4a40-93f4-01f7a890abe8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Daytime Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1113705

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-466-06Daytime Cold and Flu177 mL in 1 BOTTLE, PLASTICLIQUID1778
63941-466-08Daytime Cold and Flu237 mL in 1 BOTTLE, PLASTICLIQUID2378
63941-466-10Daytime Cold and Flu296 mL in 1 BOTTLE, PLASTICLIQUID2968
63941-466-12Daytime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID3558

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-466DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]8Current NDC, Legacy NDC, 4 package rows20240216_bfec14d5-d9ce-4b9c-a803-3d01cb00b56c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNbfec14d5-d9ce-4b9c-a803-3d01cb00b56c8
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDbfec14d5-d9ce-4b9c-a803-3d01cb00b56c8
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYbfec14d5-d9ce-4b9c-a803-3d01cb00b56c8
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYbfec14d5-d9ce-4b9c-a803-3d01cb00b56c8
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSYbfec14d5-d9ce-4b9c-a803-3d01cb00b56c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-466-0663941046606177 mL in 1 BOTTLE, PLASTIC (63941-466-06) 177 ml2015-06-300000-00-00NoNoCurrent
63941-466-0863941046608237 mL in 1 BOTTLE, PLASTIC (63941-466-08) 237 ml2015-06-300000-00-00NoNoCurrent
63941-466-1063941046610296 mL in 1 BOTTLE, PLASTIC (63941-466-10) 296 ml2015-06-300000-00-00NoNoCurrent
63941-466-1263941046612355 mL in 1 BOTTLE, PLASTIC (63941-466-12) 355 ml2015-06-300000-00-00NoNoCurrent