NDC 0363-0058

Cold and Congestion Childrens Nighttime

Diphenhydramine Hci, Phenylephrine Hcl

Cold and Congestion Childrens Nighttime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Walgreens. The primary component is Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID0363-0058_578bb763-ddee-41d3-926f-272e0e39d610
NDC0363-0058
Product TypeHuman Otc Drug
Proprietary NameCold and Congestion Childrens Nighttime
Generic NameDiphenhydramine Hci, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-03-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWalgreens
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength13 mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0363-0058-04

118 mL in 1 BOTTLE, PLASTIC (0363-0058-04)
Marketing Start Date2016-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0058-04 [00363005804]

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

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/10mL

OpenFDA Data

SPL SET ID:a7847413-e556-4f88-8a7f-a8528afbe927
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1236048

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