NDC 58593-830

Rompe Pecho Nighttime

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

Rompe Pecho Nighttime is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Efficient Laboratories Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID58593-830_d243282e-b0ae-a3b9-e053-2a95a90a9d1a
NDC58593-830
Product TypeHuman Otc Drug
Proprietary NameRompe Pecho Nighttime
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-09-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEFFICIENT LABORATORIES INC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength650 mg/30mL; 1/30mL; mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58593-830-06

1 BOTTLE in 1 CARTON (58593-830-06) > 180 mL in 1 BOTTLE
Marketing Start Date2019-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58593-830-06 [58593083006]

Rompe Pecho Nighttime LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/30mL

OpenFDA Data

SPL SET ID:2ec319a8-92bf-4552-86dd-37cbce18980f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1431245
    • UPC Code
  • 0000856301054

    • NDC Crossover Matching brand name "Rompe Pecho Nighttime" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    58593-830Rompe Pecho NighttimeRompe Pecho Nighttime
    0280-1138Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and NightAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-7580basic care daytime nighttime cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    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
    0363-6596Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-6770Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1009Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1142Day Time Night Time Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0567daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-1733daytime nighttime cold and fluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0567Good Sense NightTime DayTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0113-0019Good Sense Severe NightTimeAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0113-0763Good Sense Severe NightTime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1031Multi-Symptom Daytime and Nighttime Cold and Flu Relief PlusAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
    0363-0331Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-1011NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
    0363-0623severe cold and fluAcetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
    0363-0763Severe Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
    0363-1597Severe Cold and Fluacetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl

    Trademark Results [Rompe Pecho]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROMPE PECHO
    ROMPE PECHO
    75616526 2346815 Live/Registered
    CULEBRA HOLDINGS, LLC
    1999-01-06
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