NDC 54859-010

Dologesic DF

Acetaminophen, Dexbrompheniramine Maleate

Dologesic DF is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Acetaminophen; Dexbrompheniramine Maleate.

Product ID54859-010_82a47a73-d53b-4a86-a399-3bf439bf1d74
NDC54859-010
Product TypeHuman Otc Drug
Proprietary NameDologesic DF
Generic NameAcetaminophen, Dexbrompheniramine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameLlorens Pharmaceutical International Division
Substance NameACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54859-010-01

100 TABLET in 1 BOTTLE (54859-010-01)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-010-01 [54859001001]

Dologesic DF TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2016-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:55768b45-fd98-4779-85b6-6a50c628677e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1798459
  • 1798453

    • NDC Crossover Matching brand name "Dologesic DF" or generic name "Acetaminophen, Dexbrompheniramine Maleate"

    NDCBrand NameGeneric Name
    63102-403ACTIDOGESIC DFAcetaminophen, Dexbrompheniramine Maleate
    45737-610BiogesicAcetaminophen, Dexbrompheniramine Maleate
    54859-001DologesicAcetaminophen, Dexbrompheniramine Maleate
    54859-010DologesicAcetaminophen, Dexbrompheniramine Maleate
    52083-681G-Dologenacetaminophen, dexbrompheniramine maleate

    Trademark Results [Dologesic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DOLOGESIC
    DOLOGESIC
    87837413 5586001 Live/Registered
    LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.
    2018-03-16
    DOLOGESIC
    DOLOGESIC
    86301106 not registered Dead/Abandoned
    Llorens Pharmaceutical International Division
    2014-06-05
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