NDC 0904-1228

banophen

Diphenhydramine Hcl

banophen is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Diphenhydramine Hydrochloride.

Product ID0904-1228_7f6f28c7-d05d-89c7-e053-2991aa0ad682
NDC0904-1228
Product TypeHuman Otc Drug
Proprietary Namebanophen
Generic NameDiphenhydramine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2006-11-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMajor Pharmaceuticals
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-1228-20

1 BOTTLE in 1 CARTON (0904-1228-20) > 118 mL in 1 BOTTLE (0904-1228-00)
Marketing Start Date2006-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-1228-00 [00904122800]

banophen LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-12-09

NDC 0904-1228-20 [00904122820]

banophen LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2006-11-20
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:bafdad7e-20f4-4142-82cc-6d5d175554f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • 1092424
  • NDC Crossover Matching brand name "banophen" or generic name "Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    68071-3353banophenbanophen
    68151-2908BanophenBanophen
    70518-0285BanophenBanophen
    70518-1442BanophenBanophen
    70518-1289BanophenBanophen
    71335-0081BanophenBanophen
    0904-5354BanophenBanophen
    0904-5174BanophenBanophen
    0904-1228banophenbanophen
    0904-2035BanophenBanophen
    0904-5307BanophenBanophen
    0904-5551BanophenBanophen
    17856-5174BanophenBanophen
    50090-2935banophenbanophen
    50436-3762BanophenBanophen
    55700-678BanophenBanophen
    63187-315banophenbanophen
    68788-7830BanophenBanophen
    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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