NDC 45865-583

Diphenhydramine HCL

Diphenhydramine Hcl

Diphenhydramine HCL is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Diphenhydramine Hydrochloride.

Product ID45865-583_7d6268c7-b2aa-1bbf-e053-2a91aa0a5d32
NDC45865-583
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine HCL
Generic NameDiphenhydramine Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-01-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler Namemedsource pharmaceuticals
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45865-583-20

20 CAPSULE in 1 BOTTLE, PLASTIC (45865-583-20)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-583-20 [45865058320]

Diphenhydramine HCL CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

NDC 45865-583-30 [45865058330]

Diphenhydramine HCL CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:7d6268c7-b2a9-1bbf-e053-2a91aa0a5d32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909
  • NDC Crossover Matching brand name "Diphenhydramine HCL" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    68071-3352Diphenhydramine HCLDiphenhydramine HCL
    68788-9688Diphenhydramine HCLDiphenhydramine HCL
    68788-9687Diphenhydramine HCLDiphenhydramine HCL
    0536-1214Diphenhydramine HClDiphenhydramine HCl
    0536-3772Diphenhydramine HClDiphenhydramine HCl
    69842-537Diphenhydramine HClDiphenhydramine HCl
    70518-0277Diphenhydramine HCLDiphenhydramine HCL
    70518-0525Diphenhydramine HCLDiphenhydramine HCL
    71335-0526Diphenhydramine HCLDiphenhydramine HCL
    71335-0352Diphenhydramine HCLDiphenhydramine HCL
    72570-101Diphenhydramine HclDiphenhydramine Hcl
    10544-166Diphenhydramine HCLDiphenhydramine HCL
    11788-018Diphenhydramine HClDiphenhydramine HCl
    48769-060Diphenhydramine HClDiphenhydramine HCl
    45865-583Diphenhydramine HCLDiphenhydramine HCL
    53002-3140Diphenhydramine HCLDiphenhydramine HCL
    55154-0661Diphenhydramine HClDiphenhydramine HCl
    55154-0683Diphenhydramine HClDiphenhydramine HCl
    55289-479Diphenhydramine HClDiphenhydramine HCl
    58805-001Diphenhydramine HclDiphenhydramine Hcl
    60760-330Diphenhydramine HCLDiphenhydramine HCL
    60760-331Diphenhydramine HCLDiphenhydramine HCL
    63187-866Diphenhydramine HCLDiphenhydramine HCL
    66267-080Diphenhydramine HCLDiphenhydramine HCL
    66424-021Diphenhydramine HCLDiphenhydramine HCL
    66267-779Diphenhydramine HCLDiphenhydramine HCL
    66267-081Diphenhydramine HCLDiphenhydramine HCL
    66424-020Diphenhydramine HCLDiphenhydramine HCL
    50090-4539Diphenhydramine HCLDiphenhydramine HCL
    71399-0125Diphenhydramine HClDiphenhydramine HCl
    0904-6985Diphenhydramine HClDiphenhydramine HCl
    70934-497Diphenhydramine HCLDiphenhydramine HCL
    0113-7379basic care childrens allergy reliefDiphenhydramine HCl
    0113-7186basic care nighttime sleep aidDiphenhydramine HCl
    0113-7506basic care nighttime sleep aiddiphenhydramine hcl
    0363-0481Childrens Allergy Dye-Free Wal DrylDiphenhydramine HCl
    0113-0379good sense allergyDiphenhydramine HCl
    0113-0052good sense sleep timeDiphenhydramine HCl
    0113-0186Good Sense Sleep TimeDiphenhydramine HCl
    0363-0353Itch Relief GelDiphenhydramine HCl
    0363-0236Nighttime Sleep AidDiphenhydramine HCl
    0363-0367Sleep AidDiphenhydramine HCl
    0363-0189Sleep IIDiphenhydramine HCl
    0363-0190Wal-DrylDiphenhydramine HCl
    0363-0418Wal-DrylDiphenhydramine HCl
    0363-0329WAL-DRYL ALLERGYDiphenhydramine HCl
    0363-0020Wal-Sleep ZDiphenhydramine HCl

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