NDC 51013-184

Nitetime Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

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

Product ID51013-184_1035c6eb-df37-469d-9bc7-a131a1cf9da6
NDC51013-184
Product TypeHuman Otc Drug
Proprietary NameNitetime Cold and Flu
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-10-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePuraCap Pharmaceutical LLC
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 51013-184-01

1 BLISTER PACK in 1 CARTON (51013-184-01) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-184-01 [51013018401]

Nitetime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-12

NDC 51013-184-14 [51013018414]

Nitetime Cold and Flu CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-18

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:5633718e-1d58-498e-82a5-78be5ba74981
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094549
  • NDC Crossover Matching brand name "Nitetime Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate"

    NDCBrand NameGeneric Name
    41250-763Nitetime Cold and FluNitetime Cold and Flu
    41250-335nitetime cold and flunitetime cold and flu
    41250-872nitetime cold and flunitetime cold and flu
    41250-811nitetime cold and flunitetime cold and flu
    41250-459nitetime cold and flunitetime cold and flu
    49035-044NiteTime Cold and FluNiteTime Cold and Flu
    51013-184Nitetime Cold and FluNitetime Cold and Flu
    55301-543NiteTime Cold and FluNiteTime 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
    21130-071Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
    21130-849Cold 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
    0363-1141nighttime cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    11822-3318Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    15127-987Nighttime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0363-1005nighttime cold and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate
    15127-139Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-044Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-343Nighttime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    21130-480Safeway Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
    14505-399SanatosAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

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