Home NDC 68210-4158 MUCUS RELIEF
Product NDC 68210-4158
11-digit product format 682104158
Labeler code 68210
Product ID 68210-4158_49490f71-0257-e358-e063-6394a90a394a
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN
Dosage form TABLET
Route ORAL
Labeler Prodose, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-10
Substance GUAIFENESIN
Active strength 400 mg/1
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 MUCUS RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1
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 359601 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 68210-4158-1 MUCUS RELIEF 1 in 1 BOTTLE TABLET 1 7 68210-4158-1 MUCUS RELIEF 15 in 1 BOTTLE TABLET 15 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68210-4158 MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241215_7e5de5b0-18f0-4807-8686-da9821f918ce.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 · 3,551 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 68210-4158-1 68210415801 1 BOTTLE in 1 BOTTLE (68210-4158-1) / 15 TABLET in 1 BOTTLE 1 bottle 2021-05-25 0000-00-00 No No Current