NDC 55910-856

Ibuprofen PM

Ibuprofen, Diphenhydramine Hcl

Ibuprofen PM is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Dolgencorp, Inc. (dollar General & Rexall). The primary component is Diphenhydramine Hydrochloride; Ibuprofen.

Product ID55910-856_dfa0efe8-ca0f-4aa9-bccd-9cdac7aef39d
NDC55910-856
Product TypeHuman Otc Drug
Proprietary NameIbuprofen PM
Generic NameIbuprofen, Diphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-04-30
Marketing End Date2025-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA200888
Labeler NameDolgencorp, Inc. (DOLLAR GENERAL & REXALL)
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

Packaging

NDC 55910-856-20

1 BOTTLE, PLASTIC in 1 BOX (55910-856-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date2018-04-30
Marketing End Date2025-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55910-856-40 [55910085640]

Ibuprofen PM CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA200888
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-30

NDC 55910-856-20 [55910085620]

Ibuprofen PM CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA200888
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-30

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:8664cc8d-b56f-460d-9a52-cae6378ccaa4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 901814
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0359726165228
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Ibuprofen PM" or generic name "Ibuprofen, Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0363-0050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    0363-0207Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    0363-0250Ibuprofen PMIbuprofen, Diphenhydramine HCl
    0363-0611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofen
    0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11822-0050ibuprofen pmDiphenhydramine Citrate, Ibuprofen
    30142-050ibuprofen pmdiphenhydramine citrate and ibuprofen
    30142-232Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-165Ibuprofen PMIbuprofen and Diphenhydramine HCl
    36800-237Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    37012-050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    37808-703ibuprofen pmdiphenhydramine citrate, ibuprofen
    41250-050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    41250-285Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    41250-413ibuprofen pmDiphenhydramine citrate, Ibuprofen
    42507-050ibuprofen pmdiphenhydramine citrate, ibuprofen
    49035-670Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    68016-057Ibuprofen PMIbuprofen PM
    69842-165Ibuprofen PMIbuprofen PM
    50844-732Ibuprofen PMIbuprofen PM
    50804-165Ibuprofen PMIbuprofen PM
    50844-611Ibuprofen PMIbuprofen PM
    55315-165Ibuprofen PMIbuprofen PM
    55319-050ibuprofen pmibuprofen pm
    55910-565Ibuprofen PMIbuprofen PM
    55910-856Ibuprofen PMIbuprofen PM
    56062-050ibuprofen pmibuprofen pm
    59779-050ibuprofen pmibuprofen pm
    59779-413ibuprofen pmibuprofen pm
    0363-0413Ibuprofen PMIbuprofen PM
    63941-166Ibuprofen PMIbuprofen PM
    69842-656Ibuprofen PMIbuprofen PM
    69842-913Ibuprofen PMIbuprofen PM
    0363-0665Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-225IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
    11822-0789IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL

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