NDC 58599-004

DIPHENHYDRAMINE

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Purinepharma Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID58599-004_4924194e-5c66-4af3-b83a-5367a10248a2
NDC58599-004
Product TypeHuman Otc Drug
Proprietary NameDIPHENHYDRAMINE
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-07-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePURINEPHARMA LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58599-004-35

1 BOTTLE in 1 CARTON (58599-004-35) > 1000 CAPSULE in 1 BOTTLE
Marketing Start Date2014-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58599-004-35 [58599000435]

DIPHENHYDRAMINE CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-31
Inactivation Date2019-11-27

NDC 58599-004-29 [58599000429]

DIPHENHYDRAMINE CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-31
Inactivation Date2019-11-27

NDC 58599-004-90 [58599000490]

DIPHENHYDRAMINE CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-31
Inactivation Date2019-11-27

NDC 58599-004-25 [58599000425]

DIPHENHYDRAMINE CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-07-31
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:dac2e27b-126b-4773-9e8e-5186ca9965fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020477

    • NDC Crossover Matching brand name "DIPHENHYDRAMINE" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    68196-929diphenhydraminediphenhydramine
    76413-333DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    21695-304DiphenhydramineDiphenhydramine
    42571-169DIPHENHYDRAMINEDIPHENHYDRAMINE
    51824-048DiphenhydramineDiphenhydramine
    52959-053DiphenhydramineDiphenhydramine
    57344-090DiphenhydramineDiphenhydramine
    57344-113DiphenhydramineDiphenhydramine
    58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE
    58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE
    63323-664DiphenhydramineDiphenhydramine
    42571-337DIPHENHYDRAMINEDIPHENHYDRAMINE
    61010-4409DiphenhydramineDiphenhydramine
    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
    0031-9304Robitussin Direct Runny Nosediphenhydramine
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride
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