topcare chest congestion and sinus congestion relief pe

Generic: guaifenesin/phenylephrine

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

Drug Facts

Product Profile

Brand Name topcare chest congestion and sinus congestion relief pe
Generic Name guaifenesin/phenylephrine
Labeler topco associates llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

guaifenesin 400 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-989
Product ID 36800-989_dbeaa93d-d138-43c2-a117-9c3aafd95d3a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2006-06-05

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800989
Hyphenated Format 36800-989

Supplemental Identifiers

RxCUI
1304111
UPC
0036800147676
UNII
495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 chest congestion and sinus congestion relief pe (source: ndc)
Generic Name guaifenesin/phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-989-50) / 50 TABLET in 1 BOTTLE
source: ndc

Packages (1)

36800-989-50 1 BOTTLE in 1 CARTON (36800-989-50) / 50 TABLET in 1 BOTTLE

Ingredients (2)

guaifenesin (400 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Topcare Chest Congestion and Sinus Congestion Relief PE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dbeaa93d-d138-43c2-a117-9c3aafd95d3a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0036800147676"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["1304111"], "spl_set_id": ["b6c0362f-86ca-4f08-ba53-800c6df2c025"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-989-50)  / 50 TABLET in 1 BOTTLE", "package_ndc": "36800-989-50", "marketing_start_date": "20060605"}], "brand_name": "Topcare Chest Congestion and Sinus Congestion Relief PE", "product_id": "36800-989_dbeaa93d-d138-43c2-a117-9c3aafd95d3a", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "36800-989", "generic_name": "Guaifenesin/phenylephrine", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Chest Congestion and Sinus Congestion Relief PE", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "400 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20060605", "listing_expiration_date": "20261231"}