NDC 0363-9016

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 ID0363-9016_ca549d4b-feb6-c77f-e053-2995a90a8e1e
NDC0363-9016
Product TypeHuman Otc Drug
Proprietary NameCOLD, Flu and Sore Throat
Generic NameAcetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2021-08-24
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameWalgreens
Substance NameACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0363-9016-16

2 BLISTER PACK in 1 CARTON (0363-9016-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2021-08-24
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0363-1171COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9016COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
49035-817Cold, Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
50844-005Cold, Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
51013-197cold, flu and sore throatacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
53942-516Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
55301-618Cold, Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
55316-013cold, flu and sore throatacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
59779-916Cold, Flu and Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-9790COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9892COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
55910-862COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9017Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-5554Maximum Strength Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-9018Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-8996SEVERE DAYTIME COLD and FLUACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.