NDC 69365-001

Facol Cold and Flu Day

Acetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hydrobromide

Facol Cold and Flu Day is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Jw Holdings. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID69365-001_7aafb99a-a45c-1714-e053-2991aa0a61fc
NDC69365-001
Product TypeHuman Otc Drug
Proprietary NameFacol Cold and Flu Day
Generic NameAcetaminophen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hydrobromide
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-08-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameJW Holdings
Substance NameACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69365-001-01

1 BLISTER PACK in 1 KIT (69365-001-01) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2015-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69365-001-01 [69365000101]

Facol Cold and Flu Day CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01
Marketing End Date2015-07-07

NDC 69365-001-02 [69365000102]

Facol Cold and Flu Day CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN200 mg/1

OpenFDA Data

SPL SET ID:0e273007-36ca-320f-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1664451
  • UPC Code
  • 8806449140114

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