"82568-0016-8" National Drug Code (NDC)

Diphenhydramine Hcl 12.5 Mg Per 5 Ml 236 mL in 1 BOTTLE (82568-0016-8)
(AARNA USA INC.)

NDC Code82568-0016-8
Package Description236 mL in 1 BOTTLE (82568-0016-8)
Product NDC82568-0016
Product Type NameHUMAN OTC DRUG
Proprietary NameDiphenhydramine Hcl 12.5 Mg Per 5 Ml
Non-Proprietary NameDiphenhydramine Hcl 12.5 Mg Per 5 Ml
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20250414
Marketing Category NameOTC MONOGRAPH DRUG
Application NumberM012
ManufacturerAARNA USA INC.
Substance NameDIPHENHYDRAMINE
Strength12.5
Strength Unitmg/5mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]

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