NDC 49580-0416

Severe cold and flu Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci

Severe cold and flu Nighttime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID49580-0416_3d17d8b1-fdde-4b3c-8aac-948d8d4f934f
NDC49580-0416
Product TypeHuman Otc Drug
Proprietary NameSevere cold and flu Nighttime
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-08-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameP & L Development, LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49580-0416-8

237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)
Marketing Start Date2015-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49580-0416-8 [49580041608]

Severe cold and flu Nighttime LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-31
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:7c92bdcf-db1f-4299-982f-6a3da9cba6e6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245
  • UPC Code
  • 0349580416086
  • NDC Crossover Matching brand name "Severe cold and flu Nighttime" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hci"

    NDCBrand NameGeneric Name
    11673-677Severe Cold and Flu nighttimeSevere Cold and Flu nighttime
    49580-0515Cold MaxAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
    49580-0416Severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
    49580-4160Severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
    55319-416Severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI
    55910-716Severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI

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