NDC 58593-265

Rompe Pecho SF

Guaifenesin

Rompe Pecho SF is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Efficient Laboratories, Inc.. The primary component is Guaifenesin.

Product ID58593-265_136c8dad-c517-40be-ba09-0a35d9d90acd
NDC58593-265
Product TypeHuman Otc Drug
Proprietary NameRompe Pecho SF
Generic NameGuaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date1999-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEfficient Laboratories, Inc.
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58593-265-04

118 mL in 1 BOTTLE (58593-265-04)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58593-265-06 [58593026506]

Rompe Pecho SF LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-01
Inactivation Date2020-01-31
Reactivation Date2020-02-16

NDC 58593-265-04 [58593026504]

Rompe Pecho SF LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-01-01
Inactivation Date2020-01-31
Reactivation Date2020-02-16

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:31ff48fc-9603-413c-ab7c-2598b3e08f9c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • 1112205
  • NDC Crossover Matching brand name "Rompe Pecho SF" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    58593-265Rompe Pecho SFRompe Pecho SF
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.