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 ID: 58805-003_2be66d41-01f7-4c72-9053-3a8206b90143
• NDC: 58805-003
• Product Type: Human Otc Drug
• Proprietary Name: Acetaminophen,Dextromethorphan,Doxylamine
• Generic Name: Acetaminophen,dextromethorphan,doxylamine
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2014-05-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Agile Pharmachem
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58805-003-14

7680 CARTON in 1 BLISTER PACK (58805-003-14) > 1 CAPSULE, LIQUID FILLED in 1 CARTON

• Marketing Start Date: 2014-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58805-003-14 [58805000314]

Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-05-01
• Inactivation Date: 2020-01-31

NDC 58805-003-04 [58805000304]

Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-05-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 0c3a89d3-9b88-4cc4-bc0e-a95a95824309
• Manufacturer:
  • Agile Pharmachem
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1426334

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

NDC	Brand Name	Generic Name
58805-003	Acetaminophen,Dextromethorphan,Doxylamine	Acetaminophen,Dextromethorphan,Doxylamine
76168-056	NightTime Cold and Flu	Acetaminophen,Dextromethorphan,Doxylamine