NDC 68210-1110

COLD and FLU

Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

COLD and FLU is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals Llc. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID68210-1110_a09af094-7ce6-1d47-e053-2a95a90a6b69
NDC68210-1110
Product TypeHuman Otc Drug
Proprietary NameCOLD and FLU
Generic NameAcetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2020-03-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSpirit Pharmaceuticals LLC
Substance NameACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68210-1110-1

2 BLISTER PACK in 1 CARTON (68210-1110-1) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2020-03-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-1110-1 [68210111001]

COLD and FLU CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:8331a2a9-0857-4b64-bfb5-4f8c728e66f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815

    • NDC Crossover Matching brand name "COLD and FLU" or generic name "Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0401Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0566Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-0573Cold and FluAcetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0666Cold and Fluacetaminophen, dextromethorphan Hbr, Phenylephrine HCl
    0363-0917Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate
    0363-1213Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-2211Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-2212Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-2301Cold and Fluacetaminophen, dextromethporphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-3430Cold and FluAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
    0363-6177Cold and FluAcetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl
    0363-6406Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
    0363-6590Cold and FluAcetaminophen, Dextromethorphan HBr, Phenylephrine HCl
    42507-522Cold and FluCold and Flu
    42507-056Cold and FluCold and Flu
    42507-401Cold and FluCold and Flu
    42507-001cold and flucold and flu
    50845-0107Cold and FluCold and Flu
    56062-198Cold and FluCold and Flu
    55910-862COLD and FLUCOLD and FLU
    68210-1110COLD and FLUCOLD and FLU
    0363-7301Cold and FluCold and Flu
    0363-1171COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-5554Maximum Strength Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
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