Home NDC 60687-863 Guaifenesin
Product NDC 60687-863
11-digit product format 606870863
Labeler code 60687
Product ID 60687-863_24b1b6f4-c113-8adc-e063-6394a90a546c
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler American Health Packaging
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-20
Substance GUAIFENESIN
Active strength 200 mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Guaifenesin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-863-42 Guaifenesin 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 1 60687-863-48 Guaifenesin 10 in 1 TRAY SOLUTION 10 1 60687-863-56 Guaifenesin 10 in 1 CASE SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-863 GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING] 1 Current NDC, 3 package rows 20241021_2fd702ea-3069-472c-b99e-c527f1375705.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 73 of 178 · 3,550 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 60687-863-42 60687086342 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 60687-863-48 60687086348 10 in 1 TRAY Historical 60687-863-56 60687086356 10 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42) 10 tray 2024-10-20 No No Current