NDC 61010-4409

Diphenhydramine

Diphenhydramine Hydrochloride

Diphenhydramine is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Safetec Of America, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID61010-4409_89099217-6a54-40a1-bfce-8bb6bc55ca5c
NDC61010-4409
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine
Generic NameDiphenhydramine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-12-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSafetec of America, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 61010-4409-0

2 CAPSULE in 1 POUCH (61010-4409-0)
Marketing Start Date2019-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61010-4409-0 [61010440900]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-30

NDC 61010-4409-1 [61010440901]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-30

NDC 61010-4409-2 [61010440902]

Diphenhydramine CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-30

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

NDC Crossover Matching brand name "Diphenhydramine" or generic name "Diphenhydramine Hydrochloride"

NDCBrand NameGeneric Name
68196-929diphenhydraminediphenhydramine
76413-333DiphenhydramineDiphenhydramine
21695-500DiphenhydramineDiphenhydramine
21695-304DiphenhydramineDiphenhydramine
42571-169DIPHENHYDRAMINEDIPHENHYDRAMINE
51824-048DiphenhydramineDiphenhydramine
52959-053DiphenhydramineDiphenhydramine
57344-090DiphenhydramineDiphenhydramine
57344-113DiphenhydramineDiphenhydramine
58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE
58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE
63323-664DiphenhydramineDiphenhydramine
42571-337DIPHENHYDRAMINEDIPHENHYDRAMINE
61010-4409DiphenhydramineDiphenhydramine
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
0031-9304Robitussin Direct Runny Nosediphenhydramine
0363-0092Wal DrylDiphenhydramine Hydrochloride
0363-0379wal dryl allergyDiphenhydramine Hydrochloride
0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
0363-0223Wal-SomDiphenhydramine hydrochloride
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