NDC 58593-225

Rompe Pecho SF FLU

Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride

Rompe Pecho SF FLU is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Efficient Laboratories Inc. The primary component is Dextromethorphan Hydrobromide; Brompheniramine Maleate; Phenylephrine Hydrochloride.

Product ID58593-225_6fb9df45-a6dc-497f-8cc8-86f6598f521d
NDC58593-225
Product TypeHuman Otc Drug
Proprietary NameRompe Pecho SF FLU
Generic NameDextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2007-10-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEfficient Laboratories Inc
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58593-225-06

178 mL in 1 BOTTLE (58593-225-06)
Marketing Start Date2007-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58593-225-06 [58593022506]

Rompe Pecho SF FLU LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:bc10695a-9664-4ce3-82bb-820da06129fa
Manufacturer
UNII
UPC Code
  • 0000856332065

  • 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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