NDC 58809-116

TexaClear Nighttime Sleep-Aid

Diphenhydramine Hcl

TexaClear Nighttime Sleep-Aid is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Diphenhydramine Hydrochloride.

Product ID58809-116_150ac93e-88b7-41f9-9596-8b0586775370
NDC58809-116
Product TypeHuman Otc Drug
Proprietary NameTexaClear Nighttime Sleep-Aid
Generic NameDiphenhydramine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-06-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58809-116-08

237 mL in 1 BOTTLE (58809-116-08)
Marketing Start Date2016-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-116-08 [58809011608]

TexaClear Nighttime Sleep-Aid LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-15

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:4a16b222-d201-2663-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248354

    • NDC Crossover Matching brand name "TexaClear Nighttime Sleep-Aid" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    58809-116TexaClear Nighttime Sleep-AidTexaClear Nighttime Sleep-Aid
    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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