NDC 49580-0378

DayTime Cold and Cough Childrens

Dextromethorphan Hbr, Phenylephrine Hcl

DayTime Cold and Cough Childrens is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by P & L Development, Llc. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID49580-0378_12a4634f-7ced-4a1e-b5c0-5303c846d15d
NDC49580-0378
Product TypeHuman Otc Drug
Proprietary NameDayTime Cold and Cough Childrens
Generic NameDextromethorphan Hbr, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-03-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameP & L Development, LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49580-0378-4

118 mL in 1 BOTTLE, PLASTIC (49580-0378-4)
Marketing Start Date2016-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49580-0378-4 [49580037804]

DayTime Cold and Cough Childrens LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

OpenFDA Data

SPL SET ID:7d8ccd41-115f-4db7-a978-6775411c5f95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1544873
  • UPC Code
  • 0349580378049
  • NDC Crossover Matching brand name "DayTime Cold and Cough Childrens" or generic name "Dextromethorphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    53145-026BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
    63941-378Childrens Day Time Cold and CoughDextromethorphan HBr, Phenylephrine HCl
    55319-378Cold and Cough Day TimeDextromethorphan HBr, Phenylephrine HCl
    49580-0378DayTime Cold and CoughDextromethorphan HBr, Phenylephrine HCl
    69842-378Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    76864-464Pulmo CalcioDEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
    41520-378Triacting Day Time Cold and CoughDextromethorphan HBr, Phenylephrine HCl
    46122-327Triacting Day Time Cold and CoughDextromethorphan HBr, Phenylephrine HCl
    0363-3780Triacting Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    21130-378Triacting Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    24385-981Triacting Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    55910-378Triacting Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    63868-369Triacting Daytime Cold CoughDextromethorphan HBr, Phenylephrine HCl
    0067-8105TriaminicDextromethorphan HBr, Phenylephrine HCl

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