NDC 58602-814

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 ID58602-814_0bfd6ab5-087b-42e1-bb36-530a75e18ef2
NDC58602-814
Product TypeHuman Otc Drug
Proprietary NameDiphenhydramine HCl and Ibuprofen
Generic NameDiphenhydramine Hcl And Ibuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA210676
Labeler NameAurohealth LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58602-814-10

1 BOTTLE in 1 CARTON (58602-814-10) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2019-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-814-73 [58602081473]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

NDC 58602-814-23 [58602081423]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

NDC 58602-814-30 [58602081430]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

NDC 58602-814-10 [58602081410]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

NDC 58602-814-12 [58602081412]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

NDC 58602-814-18 [58602081418]

Diphenhydramine HCl and Ibuprofen CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA210676
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-14

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:a656f8b0-8cb4-4802-b8d3-7b95c0265d56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 901814
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • 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.