NDC 58805-006

Nightime Sleep Aid

Diphenhydramine

Nightime Sleep Aid is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Agile Pharmachem. The primary component is Diphenhydramine Hydrochloride.

Product ID58805-006_6cbc5356-76b4-5cc9-e053-2991aa0adfc8
NDC58805-006
Product TypeHuman Otc Drug
Proprietary NameNightime Sleep Aid
Generic NameDiphenhydramine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-03-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAgile Pharmachem
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58805-006-02

750 BOX in 1 BAG (58805-006-02) > 48 CAPSULE, LIQUID FILLED in 1 BOX
Marketing Start Date2014-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58805-006-02 [58805000602]

Nightime Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-09-30
Inactivation Date2020-01-31

NDC 58805-006-01 [58805000601]

Nightime Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-03-31
Inactivation Date2020-01-31

NDC 58805-006-00 [58805000600]

Nightime Sleep Aid CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-03-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:3f12bd24-8265-44a0-9112-92c026c8e2fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020477
  • NDC Crossover Matching brand name "Nightime Sleep Aid" or generic name "Diphenhydramine"

    NDCBrand NameGeneric Name
    58805-006Nightime Sleep AidDiphenhydramine
    76168-065Nightime Sleep AidDiphenhydramine
    21695-304DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    71594-700FirstCare Childrens Allergy Diphenhydramine HCl Chewable GelsDiphenhydramine
    49260-613Help I cant SleepDiphenhydramine
    50332-0132HISTAPRINDIPHENHYDRAMINE
    0498-0097North AntihistamineDIPHENHYDRAMINE
    70648-133OLP ANTI-ITCH ALLERGY RELIEFdiphenhydramine
    0031-9304Robitussin Direct Runny Nosediphenhydramine
    76168-066ZzzSleepDiphenhydramine

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