NDC 0363-0114

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 Walgreens. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID0363-0114_603c9886-f953-6327-e053-2a91aa0aba6e
NDC0363-0114
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 Date2016-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameWALGREENS
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 0363-0114-24

2 BLISTER PACK in 1 CARTON (0363-0114-24) > 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Start Date2017-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0114-24 [00363011424]

SEVERE NIGHTTIME COLD AND FLU CAPSULE, GELATIN COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-12-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:481385dd-1803-48e5-a80e-ecbd92669862
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288

    • 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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