NDC 58809-770

Childrens PediaClear 8

Pyrilamine Maleate

Childrens PediaClear 8 is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Pyrilamine Maleate.

Product ID58809-770_737b4681-54b2-4253-8e5e-1b2ffddb951d
NDC58809-770
Product TypeHuman Otc Drug
Proprietary NameChildrens PediaClear 8
Generic NamePyrilamine Maleate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-06-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NamePYRILAMINE MALEATE
Active Ingredient Strength13 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58809-770-08

237 mL in 1 BOTTLE (58809-770-08)
Marketing Start Date2019-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-770-08 [58809077008]

Childrens PediaClear 8 LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-06-25

Drug Details

Active Ingredients

IngredientStrength
PYRILAMINE MALEATE12.5 mg/15mL

OpenFDA Data

SPL SET ID:8e524967-d01c-4c93-9198-c42f15fe3fe0
Manufacturer
UNII

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