NDC 58552-322

PHENAGIL

Phenylephrine Hcl And Chlorpheniramine Maleate

PHENAGIL is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Phenylephrine Hydrochloride; Chlorpheniramine Maleate.

Product ID58552-322_69fd13a1-2b77-8574-e053-2a91aa0a27e7
NDC58552-322
Product TypeHuman Otc Drug
Proprietary NamePHENAGIL
Generic NamePhenylephrine Hcl And Chlorpheniramine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-12-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NamePHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength10 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58552-322-01

100 TABLET in 1 BOTTLE (58552-322-01)
Marketing Start Date2012-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-322-01 [58552032201]

PHENAGIL TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-12-14

NDC 58552-322-02 [58552032202]

PHENAGIL TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-14

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:69fd13a1-2b76-8574-e053-2a91aa0a27e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1367227
  • NDC Crossover Matching brand name "PHENAGIL" or generic name "Phenylephrine Hcl And Chlorpheniramine Maleate"

    NDCBrand NameGeneric Name
    58552-322PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE
    58552-337PHENAGILChlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL
    66576-322PHENAGILChlorpheniramine Maleate,Phenylephrine HCl
    66576-337PHENAGILChlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCL
    69168-302Cold and AllergyPhenylephrine HCl and Chlorpheniramine maleate
    69168-406Cold and AllergyPhenylephrine HCl and Chlorpheniramine maleate

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