Home NDC 51660-566 Guaifenesin
Product NDC 51660-566
11-digit product format 516600566
Labeler code 51660
Product ID 51660-566_4aa4fb35-6f33-6e33-e063-6394a90a495e
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Ohm Laboratories, Inc.
Application ANDA209254
Marketing category ANDA
Marketing start 2022-04-01
Substance GUAIFENESIN
Active strength 600 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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209254-001 GUAIFENESIN GUAIFENESIN 600MG TABLET, EXTENDED RELEASE / ORAL 2018-07-16 A209254-002 GUAIFENESIN GUAIFENESIN 1.2GM TABLET, EXTENDED RELEASE / ORAL 2018-07-16
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use for children under 12 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache. These could be signs of serious illness. If pregnant or breast-feeding, ask a health professional before use.
Additional Listing Data#
Finished product Yes
Brand name base Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 600 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 495W7451VQ Rxcui 310621, 636522
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51660-566-21 Guaifenesin 20 in 1 CARTON TABLET, EXTENDED RELEASE 20 4 51660-566-41 Guaifenesin 40 in 1 CARTON TABLET, EXTENDED RELEASE 40 4 51660-566-68 Guaifenesin 68 in 1 CARTON TABLET, EXTENDED RELEASE 68 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51660-566 GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 3 package rows 20250424_7076e42a-17ff-4c42-9963-2dc02c0a5e49.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51660-566-21 51660056621 20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21) 2022-04-01 0000-00-00 No No Current 51660-566-41 51660056641 40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41) 2022-04-01 0000-00-00 No No Current 51660-566-68 51660056668 68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68) 2026-01-17 No No Current