topcare ibuprofen pm

Generic: diphenhydramine citrate and ibuprofen

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

Drug Facts

Product Profile

Brand Name topcare ibuprofen pm
Generic Name diphenhydramine citrate and ibuprofen
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine citrate 38 mg/1, ibuprofen 200 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-050
Product ID 36800-050_ce7b2954-4165-4ca8-902d-8349eea450be
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079113
Listing Expiration 2026-12-31
Marketing Start 2009-02-18

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800050
Hyphenated Format 36800-050

Supplemental Identifiers

RxCUI
895664
UNII
4OD433S209 WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 ibuprofen pm (source: ndc)
Generic Name diphenhydramine citrate and ibuprofen (source: ndc)
Application Number ANDA079113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

36800-050-27 1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE 36800-050-58 1 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE 36800-050-60 1 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

diphenhydramine citrate (38 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

Topcare Ibuprofen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ce7b2954-4165-4ca8-902d-8349eea450be", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["1435e627-144e-4dc8-9ad6-58d91cbd9094"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-050-27)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-050-27", "marketing_start_date": "20090224"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-050-58)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-050-58", "marketing_start_date": "20090218"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-050-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-050-60", "marketing_start_date": "20090219"}], "brand_name": "Topcare Ibuprofen PM", "product_id": "36800-050_ce7b2954-4165-4ca8-902d-8349eea450be", "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": "36800-050", "generic_name": "diphenhydramine citrate and ibuprofen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Ibuprofen PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079113", "marketing_category": "ANDA", "marketing_start_date": "20090218", "listing_expiration_date": "20261231"}