NDC 27854-301

SEDALMEX

Acetaminophen, Caffeine

SEDALMEX is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Belmora Llc. The primary component is Acetaminophen; Caffeine.

Product ID27854-301_0e511016-8aad-46b2-b1f6-72d23c889535
NDC27854-301
Product TypeHuman Otc Drug
Proprietary NameSEDALMEX
Generic NameAcetaminophen, Caffeine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-08-08
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameBelmora LLC
Substance NameACETAMINOPHEN; CAFFEINE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 27854-301-01

1 BOTTLE in 1 CARTON (27854-301-01) > 24 TABLET in 1 BOTTLE
Marketing Start Date2019-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27854-301-01 [27854030101]

SEDALMEX TABLET
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-08

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:956ea8b3-d636-49de-813e-b25bc92fb43d
Manufacturer
UNII
UPC Code
  • 0853030002625

    • NDC Crossover Matching brand name "SEDALMEX" or generic name "Acetaminophen, Caffeine"

    NDCBrand NameGeneric Name
    27854-301SEDALMEXAcetaminophen, Caffeine
    62049-002Adults Acetaminophen and Caffeine Pain Reliever Fever ReducerACETAMINOPHEN, CAFFEINE
    0067-8139ExcedrinAcetaminophen, Caffeine
    11822-0428Tension HeadacheAcetaminophen, Caffeine
    41250-572Tension HeadacheAcetaminophen, Caffeine
    59779-824Tension HeadacheAcetaminophen, Caffeine
    59779-972Tension HeadacheAcetaminophen, Caffeine
    0363-0428Tension Headache ReliefAcetaminophen, Caffeine
    0363-0572Tension Headache ReliefAcetaminophen, Caffeine
    11673-428tension headache reliefAcetaminophen, Caffeine
    33992-0428Tension Headache ReliefAcetaminophen, Caffeine
    50844-428Tension Headache ReliefAcetaminophen, Caffeine
    55315-428Tension Headache ReliefAcetaminophen, Caffeine

    Trademark Results [SEDALMEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SEDALMEX
    SEDALMEX
    88210495 5871605 Live/Registered
    Integrated Pharma Solutions
    2018-11-29
    SEDALMEX
    SEDALMEX
    78267599 3142847 Dead/Cancelled
    Merck KGaA
    2003-06-26
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