NDC 54838-154

Silphen

Diphenhydramine Hydrochloride

Silphen is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID54838-154_55ba2a3d-ba0d-4f50-88aa-ee45b5ea5592
NDC54838-154
Product TypeHuman Otc Drug
Proprietary NameSilphen
Generic NameDiphenhydramine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1993-12-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLannett Company, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54838-154-40

118 mL in 1 BOTTLE, PLASTIC (54838-154-40)
Marketing Start Date1993-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54838-154-80 [54838015480]

Silphen SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1993-12-03

NDC 54838-154-70 [54838015470]

Silphen SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1993-12-03

NDC 54838-154-40 [54838015440]

Silphen SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1993-12-03

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:d18e22f2-8cda-4862-b437-e83648a5108a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • UPC Code
  • 0354838154405
  • NDC Crossover Matching brand name "Silphen" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    54838-154SilphenSilphen
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride

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