NDC 68163-540

severe cold and cough daytime

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

severe cold and cough daytime is a Oral Powder, For Solution in the Human Otc Drug category. It is labeled and distributed by Raritan Pharmaceuticals Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID68163-540_3ce8508e-7d9d-4413-858a-8f952e760c01
NDC68163-540
Product TypeHuman Otc Drug
Proprietary Namesevere cold and cough daytime
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2019-03-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRARITAN PHARMACEUTICALS INC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68163-540-06

6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06)
Marketing Start Date2019-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68163-540-06 [68163054006]

severe cold and cough daytime POWDER, FOR SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-14

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

NDC Crossover Matching brand name "severe cold and cough daytime" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDCBrand NameGeneric Name
36800-316Severe Cold and Cough DaytimeSevere Cold and Cough Daytime
63868-290Severe Cold and Cough DaytimeSevere Cold and Cough Daytime
67091-322Severe Cold and Cough DaytimeSevere Cold and Cough Daytime
68163-540severe cold and cough daytimesevere cold and cough daytime
0280-1590Alka-Seltzer Plus Maximum Strength Day Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0280-1630Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
0280-1221Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels DayAcetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0113-7656basic care daytime cold and fluacetaminophen, dextromethorphan hydrobromide, Phenylephrine hydrochloride
21130-598Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-650Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-868Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-311Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11868-466Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-468Day timeAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
15127-466Day Time Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0904-5763Day Time Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-866Day Time Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1140Daytime Cold and Fluacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-1583Daytime Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1000Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0363-1003Daytime Cold and Flu Reliefacetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-311Daytime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-471Daytime Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
0113-0096good sense flu and severe cold and coughAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
11822-0096severe cold cough and flu reliefAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
21130-937signature care daytime severe coldacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.