NDC 36800-264

topcare all night pain relief pm

Diphenhydramine Hydrochloride, Naproxen Sodium

topcare all night pain relief pm is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Diphenhydramine Hydrochloride; Naproxen Sodium.

Product ID36800-264_69b10f5b-5c3e-4269-95ad-68a9d38273bb
NDC36800-264
Product TypeHuman Otc Drug
Proprietary Nametopcare all night pain relief pm
Generic NameDiphenhydramine Hydrochloride, Naproxen Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA208499
Labeler NameTopco Associates LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active Ingredient Strength25 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 36800-264-27

1 BOTTLE in 1 CARTON (36800-264-27) > 80 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-264-27 [36800026427]

topcare all night pain relief pm TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208499
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-12

NDC 36800-264-60 [36800026460]

topcare all night pain relief pm TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208499
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-08

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:a20f193e-4e64-400a-b605-df08026cb80b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1550957

    • NDC Crossover Matching brand name "topcare all night pain relief pm" or generic name "Diphenhydramine Hydrochloride, Naproxen Sodium"

    NDCBrand NameGeneric Name
    36800-264topcare all night pain relief pmdiphenhydramine hydrochloride, naproxen sodium
    0113-7264basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    72288-310basic care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41520-264careone naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    55910-858dg health naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41163-593equaline naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    49035-727equate all night pain reliefdiphenhydramine hydrochloride, naproxen sodium
    0113-8264good sense naproxen sodiumdiphenhydramine hydrochloride, naproxen sodium
    30142-383naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    30142-753naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    37808-264naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    41250-526naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    21130-808signature care naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    11673-687up and up naproxen sodium pmdiphenhydramine hydrochloride, naproxen sodium
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.