NDC 69036-120

LORTUSS DM

Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride

LORTUSS DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Sallus Laboratories, Llc. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate; Pseudoephedrine Hydrochloride.

Product ID69036-120_41999ae8-18fc-49a0-a55c-ffa00f353ddd
NDC69036-120
Product TypeHuman Otc Drug
Proprietary NameLORTUSS DM
Generic NameDextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-06-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSallus Laboratories, LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69036-120-16

473 mL in 1 BOTTLE (69036-120-16)
Marketing Start Date2014-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69036-120-16 [69036012016]

LORTUSS DM LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-06-14
Marketing End Date2019-12-31
Inactivation Date2019-11-27
Reactivation Date2020-05-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:8afe55f6-7cb4-47c3-946d-6fa0126c23da
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1094350
  • UPC Code
  • 0369036120169
  • Medicade Reported Pricing

    69036012016 LORTUSS DM LIQUID

    Pricing Unit: ML | Drug Type:

    Trademark Results [LORTUSS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LORTUSS
    LORTUSS
    88817798 not registered Live/Pending
    Key Therapeutics, llc
    2020-03-02
    LORTUSS
    LORTUSS
    78149278 2818425 Dead/Cancelled
    KOWA PHARMACEUTICALS AMERICA, INC.
    2002-07-31
    LORTUSS
    LORTUSS
    74276053 not registered Dead/Abandoned
    WHITBY PHARMACEUTICALS, INC.
    1992-05-18

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