NDC 35418-111

Histenol Forte II

Phenylephrine Hcl, Acetaminophen, Guaifenesin

Histenol Forte II is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Zee Medical Inc. The primary component is Phenylephrine Hydrochloride; Acetaminophen; Guaifenesin.

Product ID35418-111_11e82391-4104-433d-b401-dd19c56bc33c
NDC35418-111
Product TypeHuman Otc Drug
Proprietary NameHistenol Forte II
Generic NamePhenylephrine Hcl, Acetaminophen, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-06-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameZee Medical Inc
Substance NamePHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Active Ingredient Strength5 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35418-111-67

125 CARTON in 1 CARTON (35418-111-67) > 50 PACKET in 1 CARTON (35418-111-68) > 2 TABLET in 1 PACKET (35418-111-02)
Marketing Start Date2012-06-12
Marketing End Date2023-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35418-111-67 [35418011167]

Histenol Forte II TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-111-68 [35418011168]

Histenol Forte II TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-111-02 [35418011102]

Histenol Forte II TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:248e8c14-4f50-46a4-8da4-d8edc47e5aac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1309062
  • UPC Code
  • 0690689014964
  • NDC Crossover Matching brand name "Histenol Forte II" or generic name "Phenylephrine Hcl, Acetaminophen, Guaifenesin"

    NDCBrand NameGeneric Name
    35418-111Histenol Forte IIPhenylephrine HCl, Acetaminophen, Guaifenesin
    42961-051Histenol Forte IIPhenylephrine HCl, Acetaminophen, Guaifenesin
    69103-2556Cold Terminator MaxPhenylephrine HCl, ACETAMINOPHEN, GUAIFENESIN

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