NDC 58805-003

Acetaminophen,Dextromethorphan,Doxylamine

Acetaminophen,dextromethorphan,doxylamine

Acetaminophen,Dextromethorphan,Doxylamine 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; Doxylamine Succinate.

Product ID58805-003_2be66d41-01f7-4c72-9053-3a8206b90143
NDC58805-003
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen,Dextromethorphan,Doxylamine
Generic NameAcetaminophen,dextromethorphan,doxylamine
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; DOXYLAMINE SUCCINATE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58805-003-14

7680 CARTON in 1 BLISTER PACK (58805-003-14) > 1 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Start Date2014-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58805-003-14 [58805000314]

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

NDC 58805-003-04 [58805000304]

Acetaminophen,Dextromethorphan,Doxylamine 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:0c3a89d3-9b88-4cc4-bc0e-a95a95824309
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1426334

    • NDC Crossover Matching brand name "Acetaminophen,Dextromethorphan,Doxylamine" or generic name "Acetaminophen,dextromethorphan,doxylamine"

    NDCBrand NameGeneric Name
    58805-003Acetaminophen,Dextromethorphan,DoxylamineAcetaminophen,Dextromethorphan,Doxylamine
    76168-056NightTime Cold and FluAcetaminophen,Dextromethorphan,Doxylamine
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