NDC 0363-1171

COLD, Flu and Sore Throat

Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

COLD, Flu and Sore Throat is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Walgreens. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 0363-1171_8c278b6f-d32d-b750-e053-2995a90ad7e9
• NDC: 0363-1171
• Product Type: Human Otc Drug
• Proprietary Name: COLD, Flu and Sore Throat
• Generic Name: Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Walgreens
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0363-1171-16

2 BLISTER PACK in 1 CARTON (0363-1171-16) > 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2019-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0363-1171-16 [00363117116]

COLD, Flu and Sore Throat CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: bdde63a7-3d81-4597-b74e-41fc55a00c9d
• Manufacturer:
  • Walgreens
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1656815

NDC Crossover Matching brand name "COLD, Flu and Sore Throat" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0363-1171	COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9016	COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
49035-817	Cold, Flu and Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
50844-005	Cold, Flu and Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
51013-197	cold, flu and sore throat	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
53942-516	Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
55301-618	Cold, Flu and Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
55316-013	cold, flu and sore throat	acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
59779-916	Cold, Flu and Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-9790	COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9892	COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
55910-862	COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9017	Maximum Strength Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-5554	Maximum Strength Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9018	Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-8996	SEVERE DAYTIME COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE