NDC 58552-334

Giltuss Allergy Plus

Chlophedianol Hcl, Chlorpheniramine Maleate, Phenylephrine Hcl

Giltuss Allergy Plus 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; Chlophedianol Hydrochloride.

Product ID58552-334_85a0dc7f-ffb6-7d52-e053-2991aa0a602a
NDC58552-334
Product TypeHuman Otc Drug
Proprietary NameGiltuss Allergy Plus
Generic NameChlophedianol Hcl, Chlorpheniramine Maleate, Phenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NamePHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active Ingredient Strength10 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-334-20

10 POUCH in 1 BOX (58552-334-20) > 2 TABLET in 1 POUCH
Marketing Start Date2018-06-22
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 58552-334-20 [58552033420]

Giltuss Allergy Plus TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-06-22

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:85a0dc7f-ffb5-7d52-e053-2991aa0a602a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1424872

    • NDC Crossover Matching brand name "Giltuss Allergy Plus" or generic name "Chlophedianol Hcl, Chlorpheniramine Maleate, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    58552-138Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
    58552-334Giltuss Allergy PlusChlophedianol HCl, Chlorpheniramine maleate, Phenylephrine HCl
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