NDC 0536-1016

Rugby Diphenhist

Diphenhydramine Hcl

Rugby Diphenhist is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Diphenhydramine Hydrochloride.

Product ID0536-1016_7f6b64d0-b0e5-4d15-e053-2a91aa0a552e
NDC0536-1016
Product TypeHuman Otc Drug
Proprietary NameRugby Diphenhist
Generic NameDiphenhydramine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-12-13
Marketing End Date2021-08-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRUGBY LABORATORIES
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN

Packaging

NDC 0536-1016-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1016-01)
Marketing Start Date2014-12-13
Marketing End Date2021-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1016-01 [00536101601]

Rugby Diphenhist TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-12-13
Marketing End Date2021-08-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ae7957ee-72b3-46f8-966c-526ac894af92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049630
  • 1092446
  • NDC Crossover Matching brand name "Rugby Diphenhist" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0536-1016Rugby DiphenhistRugby Diphenhist
    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

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