NDC 0363-9892

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE

Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE 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: 0363-9892_6017de95-ac32-01dc-e053-2991aa0ade7e
• NDC: 0363-9892
• Product Type: Human Otc Drug
• Proprietary Name: COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE
• Generic Name: Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-15
• 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: 2019-12-31

Packaging

NDC 0363-9892-24

2 BLISTER PACK in 1 CARTON (0363-9892-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2017-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0363-9892-24 [00363989224]

COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-12-15

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 371cd563-e249-4f2c-ae68-7a50c8f16ade
• Manufacturer:
  • Walgreens
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1656815

NDC Crossover Matching brand name "COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
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
68210-1110	COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
68210-4084	COLD and FLU	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
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
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