topcare all night pain relief pm

Generic: diphenhydramine hydrochloride, naproxen sodium

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare all night pain relief pm
Generic Name diphenhydramine hydrochloride, naproxen sodium
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, naproxen sodium 220 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-264
Product ID 36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208499
Listing Expiration 2026-12-31
Marketing Start 2019-08-08

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800264
Hyphenated Format 36800-264

Supplemental Identifiers

RxCUI
1550957
UNII
TC2D6JAD40 9TN87S3A3C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topcare all night pain relief pm (source: ndc)
Generic Name diphenhydramine hydrochloride, naproxen sodium (source: ndc)
Application Number ANDA208499 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 220 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

36800-264-27 1 BOTTLE in 1 CARTON (36800-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE 36800-264-60 1 BOTTLE in 1 CARTON (36800-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (25 mg/1) naproxen sodium (220 mg/1)

Linked Drug Pages (1)

topcare all night pain relief pm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32352610-bdfc-40f5-8d85-daa6fc9f7ae4", "openfda": {"unii": ["TC2D6JAD40", "9TN87S3A3C"], "rxcui": ["1550957"], "spl_set_id": ["a20f193e-4e64-400a-b605-df08026cb80b"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-264-27)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-264-27", "marketing_start_date": "20190812"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-264-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-264-60", "marketing_start_date": "20190808"}], "brand_name": "topcare all night pain relief pm", "product_id": "36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "36800-264", "generic_name": "diphenhydramine hydrochloride, naproxen sodium", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare all night pain relief pm", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}], "application_number": "ANDA208499", "marketing_category": "ANDA", "marketing_start_date": "20190808", "listing_expiration_date": "20261231"}