NDC 58599-003

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 ID58599-003_0c90365e-c06d-4368-b627-aac3c415ddd2
NDC58599-003
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 Strength25 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58599-003-25

1 BOTTLE in 1 CARTON (58599-003-25) > 50 CAPSULE in 1 BOTTLE
Marketing Start Date2014-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58599-003-29 [58599000329]

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

NDC 58599-003-25 [58599000325]

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

NDC 58599-003-35 [58599000335]

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

NDC 58599-003-90 [58599000390]

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 HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:d72be275-850f-420c-aa68-66cbfcf87160
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909

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