Home NDC 83720-503 Guaifenesin
Product NDC 83720-503
11-digit product format 837200503
Labeler code 83720
Product ID 83720-503_47a7ba26-2ec3-a544-e063-6394a90adc14
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Oncor Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-10
Substance GUAIFENESIN
Active strength 100 mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310604 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83720-503-16 Guaifenesin 473 mL in 1 BOTTLE LIQUID 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83720-503 GUAIFENESIN LIQUID [ONCOR PHARMACEUTICALS] 3 Current NDC, 1 package rows 20240511_fd35036c-b722-48a3-85fd-60471beb6e74.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 Sample Exclude flag Status 83720-503-16 83720050316 473 mL in 1 BOTTLE (83720-503-16) 473 ml 2024-05-10 No No Current