NDC 55316-052

Healthy Accents Sleeptime

Diphenhydramine Hcl

Healthy Accents Sleeptime is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Dza Brands Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID55316-052_6f34f8cb-6ef2-4ad1-a4a5-39d938bceac0
NDC55316-052
Product TypeHuman Otc Drug
Proprietary NameHealthy Accents Sleeptime
Generic NameDiphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-05-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart338
Labeler NameDZA Brands LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55316-052-53

12 BLISTER PACK in 1 CARTON (55316-052-53) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-05-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-052-53 [55316005253]

Healthy Accents Sleeptime CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-11
Marketing End Date2019-01-01

NDC 55316-052-62 [55316005262]

Healthy Accents Sleeptime CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart338
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-11
Marketing End Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:be1f77f8-dd30-4e7c-96a3-2e93ab9f3e7a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049909
  • NDC Crossover Matching brand name "Healthy Accents Sleeptime" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    55316-186healthy accents sleeptimehealthy accents sleeptime
    55316-052Healthy Accents SleeptimeHealthy Accents Sleeptime
    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

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