NDC 58805-002

Acetaminophen,Dextromethorphan,Phenylephrine

Acetaminophen,dextromethorphan,phenylephrine

Acetaminophen,Dextromethorphan,Phenylephrine is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Agile Pharmachem. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID58805-002_641e15a2-c46c-4171-8918-4f752d79231d
NDC58805-002
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen,Dextromethorphan,Phenylephrine
Generic NameAcetaminophen,dextromethorphan,phenylephrine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAgile Pharmachem
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58805-002-14

7680 CARTON in 1 BLISTER PACK (58805-002-14) > 1 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Start Date2014-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58805-002-08 [58805000208]

Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-01-16
Inactivation Date2020-01-31

NDC 58805-002-14 [58805000214]

Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:563452d1-0c19-4094-895a-805c859bc49b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086997

    • NDC Crossover Matching brand name "Acetaminophen,Dextromethorphan,Phenylephrine" or generic name "Acetaminophen,dextromethorphan,phenylephrine"

    NDCBrand NameGeneric Name
    58805-002Acetaminophen,Dextromethorphan,PhenylephrineAcetaminophen,Dextromethorphan,Phenylephrine
    62011-0318DayTime Cold and FluAcetaminophen,Dextromethorphan,Phenylephrine
    70677-0011DayTime Cold and FluAcetaminophen,Dextromethorphan,Phenylephrine
    76168-055DayTime Cold and FluAcetaminophen,Dextromethorphan,Phenylephrine
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