NDC 11868-311

Cold Preparation

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Cold Preparation is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by New Genesis/monticello Drug Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID11868-311_4cf509b4-c1e2-4e71-ab1f-3009ca4be3d8
NDC11868-311
Product TypeHuman Otc Drug
Proprietary NameCold Preparation
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-08-31
Marketing End Date2020-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNew Genesis/Monticello Drug LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN

Packaging

NDC 11868-311-08

237 mL in 1 BOTTLE, PLASTIC (11868-311-08)
Marketing Start Date2014-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11868-311-08 [11868031108]

Cold Preparation LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-31
Marketing End Date2020-01-01

NDC 11868-311-12 [11868031112]

Cold Preparation LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-31
Marketing End Date2020-01-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:510b09c3-0e1e-442d-a5f6-138872813988
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
    • UPC Code
  • 0311868002120

    • NDC Crossover Matching brand name "Cold Preparation" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    11868-311Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    11868-466Cold PreparationAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
    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
    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
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