NDC 49963-630

Clophed

Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride

Clophed is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Portal Pharmaceutical. The primary component is Chlophedianol Hydrochloride; Guaifenesin; Phenylephrine Hydrochloride.

Product ID49963-630_11108f5d-d9ea-498e-ba87-a6eff07dfa7f
NDC49963-630
Product TypeHuman Otc Drug
Proprietary NameClophed
Generic NameChlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2010-05-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePortal Pharmaceutical
Substance NameCHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49963-630-15

15 mL in 1 BOTTLE (49963-630-15)
Marketing Start Date2010-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49963-630-04 [49963063004]

Clophed LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-05-28
Inactivation Date2019-10-29

NDC 49963-630-15 [49963063015]

Clophed LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-04
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:49370e61-f9db-47d0-a43f-b1797b077867
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1048075

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