NDC 53345-026

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 ID53345-026_046e6ccf-3de4-4834-ad75-44380a0d7aa4
NDC53345-026
Product TypeHuman Otc Drug
Proprietary NameNighttime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-08-11
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 Through2020-12-31

Packaging

NDC 53345-026-01

1 BAG in 1 BOX (53345-026-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2014-08-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-026-01 [53345002601]

Nighttime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:7a28d0fe-0e0a-453a-b604-1cc784dd153c
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
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