NDC 72570-101

Diphenhydramine Hcl

Diphenhydramine Hydrochloride

Diphenhydramine Hcl is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Delsam Pharma Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID72570-101_55e8460d-3963-4025-a540-e4468f006011
NDC72570-101
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine Hcl
Generic NameDiphenhydramine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2018-09-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDelsam Pharma Llc
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 72570-101-04

1 BOTTLE, PLASTIC in 1 CARTON (72570-101-04) > 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2018-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72570-101-04 [72570010104]

Diphenhydramine Hcl SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:9a6a6d0a-ee5e-47dd-923e-d84be48c6054
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • NDC Crossover Matching brand name "Diphenhydramine Hcl" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    68071-3352Diphenhydramine HCLDiphenhydramine HCL
    68788-9688Diphenhydramine HCLDiphenhydramine HCL
    68788-9687Diphenhydramine HCLDiphenhydramine HCL
    0536-1214Diphenhydramine HClDiphenhydramine HCl
    0536-3772Diphenhydramine HClDiphenhydramine HCl
    69842-537Diphenhydramine HClDiphenhydramine HCl
    70518-0277Diphenhydramine HCLDiphenhydramine HCL
    70518-0525Diphenhydramine HCLDiphenhydramine HCL
    71335-0526Diphenhydramine HCLDiphenhydramine HCL
    71335-0352Diphenhydramine HCLDiphenhydramine HCL
    72570-101Diphenhydramine HclDiphenhydramine Hcl
    10544-166Diphenhydramine HCLDiphenhydramine HCL
    11788-018Diphenhydramine HClDiphenhydramine HCl
    48769-060Diphenhydramine HClDiphenhydramine HCl
    45865-583Diphenhydramine HCLDiphenhydramine HCL
    53002-3140Diphenhydramine HCLDiphenhydramine HCL
    55154-0661Diphenhydramine HClDiphenhydramine HCl
    55154-0683Diphenhydramine HClDiphenhydramine HCl
    55289-479Diphenhydramine HClDiphenhydramine HCl
    58805-001Diphenhydramine HclDiphenhydramine Hcl
    60760-330Diphenhydramine HCLDiphenhydramine HCL
    60760-331Diphenhydramine HCLDiphenhydramine HCL
    63187-866Diphenhydramine HCLDiphenhydramine HCL
    66267-080Diphenhydramine HCLDiphenhydramine HCL
    66424-021Diphenhydramine HCLDiphenhydramine HCL
    66267-779Diphenhydramine HCLDiphenhydramine HCL
    66267-081Diphenhydramine HCLDiphenhydramine HCL
    66424-020Diphenhydramine HCLDiphenhydramine HCL
    50090-4539Diphenhydramine HCLDiphenhydramine HCL
    71399-0125Diphenhydramine HClDiphenhydramine HCl
    0904-6985Diphenhydramine HClDiphenhydramine HCl
    70934-497Diphenhydramine HCLDiphenhydramine HCL
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0113-7379basic care childrens allergy reliefDiphenhydramine HCl
    0113-7186basic care nighttime sleep aidDiphenhydramine HCl
    0113-7506basic care nighttime sleep aiddiphenhydramine hcl
    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
    0113-0379good sense allergyDiphenhydramine HCl
    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
    0113-0052good sense sleep timeDiphenhydramine HCl

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