topcare sinus and cold d

Generic: naproxen sodium, pseudoephedrine hcl

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

Drug Facts

Product Profile

Brand Name topcare sinus and cold d
Generic Name naproxen sodium, pseudoephedrine hcl
Labeler topco associates llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

naproxen sodium 220 mg/1, pseudoephedrine hydrochloride 120 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-417
Product ID 36800-417_7cdb2600-a9fa-4fe8-9161-4f051bb1243b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076518
Listing Expiration 2026-12-31
Marketing Start 2013-08-14

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800417
Hyphenated Format 36800-417

Supplemental Identifiers

RxCUI
1367426
UNII
9TN87S3A3C 6V9V2RYJ8N

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 sinus and cold d (source: ndc)
Generic Name naproxen sodium, pseudoephedrine hcl (source: ndc)
Application Number ANDA076518 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 220 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

36800-417-01 20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

naproxen sodium (220 mg/1) pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

Topcare Sinus and Cold D ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7cdb2600-a9fa-4fe8-9161-4f051bb1243b", "openfda": {"unii": ["9TN87S3A3C", "6V9V2RYJ8N"], "rxcui": ["1367426"], "spl_set_id": ["55c177ce-1729-4a9b-a5ae-2b6c96fbc27a"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (36800-417-01)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-417-01", "marketing_start_date": "20130814"}], "brand_name": "Topcare Sinus and Cold D", "product_id": "36800-417_7cdb2600-a9fa-4fe8-9161-4f051bb1243b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "36800-417", "generic_name": "Naproxen sodium, Pseudoephedrine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Sinus and Cold D", "active_ingredients": [{"name": "NAPROXEN SODIUM", "strength": "220 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076518", "marketing_category": "ANDA", "marketing_start_date": "20130814", "listing_expiration_date": "20261231"}