NDC 53345-006

Nighttime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

Nighttime Cold and Flu is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID53345-006_bb21cc5e-e5c6-44ea-b95e-0be0f0d48e8f
NDC53345-006
Product TypeHuman Otc Drug
Proprietary NameNighttime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2013-04-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-006-01

1 BAG in 1 BOX (53345-006-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2013-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-006-01 [53345000601]

Nighttime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:a01abac3-c13e-40f2-ae98-34bd6c9b7504
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094549

    • NDC Crossover Matching brand name "Nighttime Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    0363-0460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
    0363-0850Nighttime Cold and FluAcetaminophen Dextromethorphan HBr Doxylamine succinate
    0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-1141nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    0363-9975Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    0363-9976Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate
    11673-460Nighttime Cold and FluAcetaminophen, Diphenhydramine HCI, Phenylephrine HCI
    11822-3318Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    11822-6859Nighttime Cold and FluAcetaminophen Diphenhydramine HCl Phenylephrine HCl
    15127-987Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    70005-005NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
    76168-056NightTime Cold and FluNightTime Cold and Flu
    37012-335Nighttime Cold and FluNighttime Cold and Flu
    37835-952NIGHTTIME COLD AND FLUNIGHTTIME COLD AND FLU
    49035-041Nighttime Cold and FluNighttime Cold and Flu
    49348-157Nighttime cold and fluNighttime cold and flu
    49738-480Nighttime cold and fluNighttime cold and flu
    50804-480Nighttime cold and fluNighttime cold and flu
    51013-193Nighttime Cold and FluNighttime Cold and Flu
    51013-147NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
    51013-131NIGHTTIME COLD and FLUNIGHTTIME COLD and FLU
    53345-006Nighttime Cold and FluNighttime Cold and Flu
    53441-342Nighttime Cold and FluNighttime Cold and Flu
    53441-346Nighttime Cold and FluNighttime Cold and Flu
    53345-026Nighttime Cold and FluNighttime Cold and Flu
    53441-343Nighttime Cold and FluNighttime Cold and Flu
    55316-012Nighttime Cold and FluNighttime Cold and Flu
    63868-219Nighttime Cold and FluNighttime Cold and Flu
    46994-344Nighttime Cold and FluNighttime Cold and Flu
    66715-6716Nighttime Cold and FluNighttime Cold and Flu
    66715-6816Nighttime Cold and FluNighttime Cold and Flu
    41250-586NightTime Cold and FluNightTime Cold and Flu
    0363-3430Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    15127-346Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    11822-5832Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    11523-0077Coricidin HBP Maximum Strength Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate
    0904-5764Major Night Time Multi SymptomAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    11822-0403Night TimeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    11822-1403Night Time CherryAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0904-6996Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
    11822-1406Night Time OriginalAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0363-1005nighttime cold and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    15127-139Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    14505-399SanatosAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.