NDC 36800-659

SEVERE NIGHTTIME COLD AND FLU

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

SEVERE NIGHTTIME COLD AND FLU is a Oral Capsule, Gelatin Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID36800-659_9631e36b-78f2-3bc4-e053-2995a90a05da
NDC36800-659
Product TypeHuman Otc Drug
Proprietary NameSEVERE NIGHTTIME COLD AND FLU
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2019-10-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopCo Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-659-24

2 BLISTER PACK in 1 CARTON (36800-659-24) > 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Start Date2019-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-659-24 [36800065924]

SEVERE NIGHTTIME COLD AND FLU CAPSULE, GELATIN COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

NDC Crossover Matching brand name "SEVERE NIGHTTIME COLD AND FLU" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride"

NDCBrand NameGeneric Name
0363-0114SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
0363-8997SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-659SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-624SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-669SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
68210-4087SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
69842-625SEVERE NIGHTTIME COLD AND FLUSEVERE NIGHTTIME COLD AND FLU
0280-0922Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-848Cold and Flu Severe NighttimeAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
63824-593Mucinex Fast-MaxAcetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride
0363-6140NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-530NyQuil Severe plusacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
69423-989NyQuil VapoCOOL SEVEREacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-528Sinex Severe plusacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
64336-175Sinex Severe plusacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
50580-571TYLENOL COLD MAXAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
50580-369Tylenol Cold plus Flu plus CoughAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-531Vicks Formula 44 VapoCoolacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-812Vicks NyQuilAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-815Vicks NyQuilacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
0363-6111Walgreen Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
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