NDC 67751-169

Sominex

Diphenhydramine Hydrochloride

Sominex is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Navajo Manufacturing Company Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID67751-169_3d1f3084-4c8f-02b6-e054-00144ff8d46c
NDC67751-169
Product TypeHuman Otc Drug
Proprietary NameSominex
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-09-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameNavajo Manufacturing Company Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67751-169-01

1 PACKET in 1 CARTON (67751-169-01) > 8 TABLET in 1 PACKET
Marketing Start Date2016-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67751-169-01 [67751016901]

Sominex TABLET
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-22

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:9d2cbdff-2231-4d80-8481-22bcb8385506
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • 1086986
  • NDC Crossover Matching brand name "Sominex" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    67751-169SominexSominex
    63029-555SominexSominex
    63029-554SominexSominex
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride

    Trademark Results [Sominex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOMINEX
    SOMINEX
    71688457 0633508 Live/Registered
    PHARMACEUTICALS, INC.
    1955-05-27

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