NDC 58602-717

Diphenhydramine HCl and Ibuprofen

Diphenhydramine Hcl And Ibuprofen

Diphenhydramine HCl and Ibuprofen is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Diphenhydramine Hydrochloride; Ibuprofen.

Product ID58602-717_39af6dfa-e822-43a5-bd1a-338cf5da89ce
NDC58602-717
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine HCl and Ibuprofen
Generic NameDiphenhydramine Hcl And Ibuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2022-12-09
Marketing CategoryANDA /
Application NumberANDA210676
Labeler NameAurohealth LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58602-717-30

160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)
Marketing Start Date2022-12-09
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Diphenhydramine HCl and Ibuprofen" or generic name "Diphenhydramine Hcl And Ibuprofen"

NDCBrand NameGeneric Name
58602-717Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and Ibuprofen
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and Ibuprofen
58602-887Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and Ibuprofen

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