NDC 76281-501

Nite-Time COLD/FLU Medicine

Acetaminophen

Nite-Time COLD/FLU Medicine is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Aptapharma Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID76281-501_7774a04f-beb0-4a28-8087-b75c847ad9b4
NDC76281-501
Product TypeHuman Otc Drug
Proprietary NameNite-Time COLD/FLU Medicine
Generic NameAcetaminophen
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-03-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAptaPharma Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76281-501-25

177 mL in 1 BOTTLE (76281-501-25)
Marketing Start Date2018-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76281-501-28 [76281050128]

Nite-Time COLD/FLU Medicine LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-09

NDC 76281-501-25 [76281050125]

Nite-Time COLD/FLU Medicine LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-16
Marketing End Date2013-02-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:344440bc-d810-4296-93ec-e6ae6673856b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043400

    • NDC Crossover Matching brand name "Nite-Time COLD/FLU Medicine" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    76281-501Nite-Time COLD/FLU MedicineNite-Time COLD/FLU Medicine
    0121-0657AcetaminophenAcetaminophen
    0113-7000Basic Care acetaminophenAcetaminophen
    0113-7484basic care acetaminophenAcetaminophen
    0113-7544Basic Care AcetaminophenAcetaminophen
    0113-7130basic care childrens pain and feverAcetaminophen
    0113-0020good sense childrens pain and feverAcetaminophen
    0113-0212Good Sense Childrens Pain and FeverAcetaminophen
    0113-0608good sense childrens pain and feverAcetaminophen
    0113-0998Good Sense Childrens Pain and FeverAcetaminophen
    0113-0161Good Sense pain and feverAcetaminophen
    0113-0397Good Sense Pain and Feveracetaminophen
    0113-0590Good Sense Pain and Feveracetaminophen
    0113-0946good sense pain and feverAcetaminophen
    0113-8959Good Sense Pain and FeverAcetaminophen
    0113-0025Good Sense Pain ReliefAcetaminophen
    0113-0044Good Sense Pain ReliefAcetaminophen
    0113-0187good sense pain reliefAcetaminophen
    0113-0217good sense pain reliefAcetaminophen
    0113-0227Good Sense Pain ReliefAcetaminophen
    0113-0403good sense pain reliefAcetaminophen
    0113-0484Good Sense Pain ReliefAcetaminophen
    0113-0518good sense pain reliefAcetaminophen
    0113-0544good sense pain reliefAcetaminophen
    0113-1889good sense pain reliefacetaminophen
    0113-1975Good Sense Pain ReliefAcetaminophen
    0031-9301Robitussin Direct Sore Throat Painacetaminophen

    Trademark Results [Nite-Time]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NITE-TIME
    NITE-TIME
    85359292 4448185 Live/Registered
    Northeast Textiles, Inc.
    2011-06-29
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