Home NDC 69618-061 Guaifenesin
Product NDC 69618-061
11-digit product format 696180061
Labeler code 69618
Product ID 69618-061_2bc81e27-90e3-930d-e063-6394a90a699d
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Reliable 1 Laboratories LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-01
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 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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69618-061-06 Guaifenesin 60 in 1 BOTTLE, PLASTIC TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-061 GUAIFENESIN TABLET [RELIABLE 1 LABORATORIES LLC] 5 Current NDC, Legacy NDC, 1 package rows 20250117_ae469d4f-91c4-cff0-e053-2995a90a0497.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 98 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 69618-061-06 69618006106 60 TABLET in 1 BOTTLE, PLASTIC (69618-061-06) 60 tablet 2020-08-01 0000-00-00 No No Current