NDC 55319-001

Severe Cold Multi Symptom

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cold Multi Symptom is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Family Dollar (family Wellness). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 55319-001_a3f0ae80-cf9a-4b6d-a678-c5ef642cd6c1
• NDC: 55319-001
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold Multi Symptom
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-31
• Marketing End Date: 2021-12-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Family Dollar (FAMILY WELLNESS)
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N

Packaging

NDC 55319-001-08

237 mL in 1 BOTTLE, PLASTIC (55319-001-08)

• Marketing Start Date: 2015-08-31
• Marketing End Date: 2021-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55319-001-08 [55319000108]

Severe Cold Multi Symptom LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-08-31
• Marketing End Date: 2021-12-30

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL

OpenFDA Data

• SPL SET ID: 854833ea-1c90-4011-bd88-cfb6a61b0361
• Manufacturer:
  • Family Dollar (FAMILY WELLNESS)
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1369842
• UPC Code:
  • 0032251033766

NDC Crossover Matching brand name "Severe Cold Multi Symptom" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
55319-001	Severe Cold Multi Symptom	Severe Cold Multi Symptom
63868-073	Severe Cold Multi Symptom	Severe Cold Multi Symptom
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0719	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl