Home NDC 36800-989 Topcare Chest Congestion and Sinus Congestion Relief PE
Product NDC 36800-989
11-digit product format 368000989
Labeler code 36800
Product ID 36800-989_dbeaa93d-d138-43c2-a117-9c3aafd95d3a
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin/phenylephrine
Dosage form TABLET
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-06-05
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 400; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topcare Chest Congestion and Sinus Congestion Relief PE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1304111 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-989-50 Topcare Chest Congestion and Sinus Congestion Relief PE 1 in 1 CARTON TABLET 1 3 36800-989-50 Topcare Chest Congestion and Sinus Congestion Relief PE 50 in 1 BOTTLE TABLET 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-989 TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241220_b6c0362f-86ca-4f08-ba53-800c6df2c025.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-989-50 36800098950 1 BOTTLE in 1 CARTON (36800-989-50) / 50 TABLET in 1 BOTTLE 1 bottle 2006-06-05 0000-00-00 No No Current