NDC 55319-993

Severe Cold and Mucus

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Guaifenesin

Severe Cold and Mucus is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Family Dollar, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 55319-993_34aceae8-700f-445b-8b35-37943dcac8c7
• NDC: 55319-993
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Mucus
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Guaifenesin
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Family Dollar, Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55319-993-20

1 BOTTLE in 1 CARTON (55319-993-20) > 240 mL in 1 BOTTLE

• Marketing Start Date: 2016-06-09
• Marketing End Date: 2022-06-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55319-993-20 [55319099320]

Severe Cold and Mucus LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-06-09

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: e4a09f60-c586-4e5f-a48b-4613b98d0c70
• Manufacturer:
  • Family Dollar, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1369842

NDC Crossover Matching brand name "Severe Cold and Mucus" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Guaifenesin"

NDC	Brand Name	Generic Name
55319-993	Severe Cold and Mucus	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin
55910-995	Severe Cold and Mucus	acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin