NDC 50580-533

Benadryl Allergy EXTRA STRENGTH

Diphenhydramine Hydrochloride

Benadryl Allergy EXTRA STRENGTH is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Diphenhydramine Hydrochloride.

Product ID50580-533_dd0a8069-18d9-5696-e053-2995a90a2f22
NDC50580-533
Product TypeHuman Otc Drug
Proprietary NameBenadryl Allergy EXTRA STRENGTH
Generic NameDiphenhydramine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-07-05
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50580-533-24

2 BLISTER PACK in 1 CARTON (50580-533-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2022-07-05
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Benadryl Allergy EXTRA STRENGTH" or generic name "Diphenhydramine Hydrochloride"

NDCBrand NameGeneric Name
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

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