NDC 69842-413

cooling severe nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

cooling severe nighttime is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Cvs Pharmacy. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID69842-413_3973ab80-c2e4-4b26-bb94-261d295bfba6
NDC69842-413
Product TypeHuman Otc Drug
Proprietary Namecooling severe nighttime
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-12-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCVS Pharmacy
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69842-413-62

12 BLISTER PACK in 1 CARTON (69842-413-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69842-413-62 [69842041362]

cooling severe nighttime TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

NDC Crossover Matching brand name "cooling severe nighttime" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride"

NDCBrand NameGeneric Name
69842-590cooling severe nighttimecooling severe nighttime
69842-413cooling severe nighttimecooling severe nighttime
0280-1580Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1581Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1600Alka-Seltzer Plus Maximum Strength Night Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1640Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gelsacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0280-1610Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1620Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0280-1222Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels NightAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
0113-7501basic care nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0113-7763basic care nigttime cold and flu severeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
41520-770careone allergy and cough severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
11822-0591cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
49035-315Day and Night Cold and Flu Formulaacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0363-1658Dye Free Cold and FluAcetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
46122-272good neighbor pharmacy severe sinus congestionAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
36800-411Night Time Cold and Flu SevereAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
37808-606Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
0363-5900nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
21130-595signature care nighttime severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
36800-307topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
36800-594topcare nite time cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
11673-763up and up nighttime severe cold and fluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
11673-251up and up nighttime vapor ice cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.