NDC 36800-316

Severe Cold and Cough Daytime

Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl

Severe Cold and Cough Daytime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Top Care (topco Associates Llc). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID36800-316_1fcb6647-015c-42e5-b416-69d54c877a4f
NDC36800-316
Product TypeHuman Otc Drug
Proprietary NameSevere Cold and Cough Daytime
Generic NameAcetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTOP CARE (Topco Associates LLC)
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-316-08

245 mL in 1 BOTTLE, PLASTIC (36800-316-08)
Marketing Start Date2015-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-316-08 [36800031608]

Severe Cold and Cough Daytime LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-11-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:c6475e58-5152-4dad-be2f-4ca32b8589d7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
  • UPC Code
  • 0036800224490
  • NDC Crossover Matching brand name "Severe Cold and Cough Daytime" or generic name "Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    63868-290Severe Cold and Cough DaytimeSevere Cold and Cough Daytime
    67091-322Severe Cold and Cough DaytimeSevere Cold and Cough Daytime
    68163-540severe cold and cough daytimesevere cold and cough daytime
    33992-0742Cold and FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    55315-742Cold and FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0904-6793Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    0904-6995Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    49348-738Day Time PEACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    41520-473DAYTIMEACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    50804-468DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    41250-568DayTime Cold and FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    41250-646DayTime Cold and FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    50804-742Daytime Cold FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    49738-470DayTime Cold Flu Non-DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    55315-316Daytime Flu Relief TherapyACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    33992-0468DayTime Multi-SymptomACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    37808-016Flu Relief TherapyACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    46122-015Flu Relief TherapyACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    15127-923Flu Relief Therapy DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    41520-068Multi-Symptom Cold and FluACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    36800-316Severe Cold and CoughACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    42507-316Severe Cold and Cough ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    46122-336Severe Cold and Cough ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    49580-0501Severe Cold and Cough ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
    50804-316Severe Cold and Cough ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.