Home NDC 43063-801 Guaifenesin DM
Product NDC 43063-801
11-digit product format 430630801
Labeler code 43063
Product ID 43063-801_06c3176d-e6f9-4231-e063-6394a90a694b
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-02
Marketing end 2027-11-30
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 400; 20 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
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 DM Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147685 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 43063-801-30 Guaifenesin DM 30 in 1 BOTTLE, PLASTIC TABLET 30 9 43063-801-60 Guaifenesin DM 60 in 1 BOTTLE, PLASTIC TABLET 60 9 43063-801-90 Guaifenesin DM 90 in 1 BOTTLE, PLASTIC TABLET 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-801 GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 3 package rows 20231003_ac8c0c15-b305-47f2-8712-e4b53636f7fa.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 97 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 43063-801-30 43063080130 30 TABLET in 1 BOTTLE, PLASTIC (43063-801-30) 30 tablet 2018-04-02 2027-11-30 No No Historical 43063-801-60 43063080160 60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60) 60 tablet 2018-04-02 2027-11-30 No No Current 43063-801-90 43063080190 90 TABLET in 1 BOTTLE, PLASTIC (43063-801-90) 90 tablet 2018-04-02 2027-11-30 No No Current