Home NDC 71679-148 Guaifenesin 200mg
Product NDC 71679-148
11-digit product format 716790148
Labeler code 71679
Product ID 71679-148_55fed532-bf59-93f5-e063-6394a90ad99b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET
Route ORAL
Labeler Health Pharma USA LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-18
Substance GUAIFENESIN
Active strength 200 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 Guaifenesin 200mg
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 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 197741 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 71679-148-02 Guaifenesin 200mg 200 in 1 BOTTLE TABLET 200 11 71679-148-30 Guaifenesin 200mg 30 in 1 BOTTLE TABLET 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71679-148 GUAIFENESIN 200MG (GUAIFENESIN) TABLET [HEALTH PHARMA USA LLC] 4 Current NDC, Legacy NDC, 2 package rows 20231031_d68222f7-b796-7b27-e053-2995a90a2efe.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 71679-148-02 71679014802 200 TABLET in 1 BOTTLE (71679-148-02) 200 tablet 2025-06-18 0000-00-00 No No Current 71679-148-30 71679014830 30 TABLET in 1 BOTTLE (71679-148-30) 30 tablet 2025-06-18 No No Current