Home NDC 68788-8268-1 robafen dm
Product NDC 68788-8268
Requested package NDC 68788-8268-1
11-digit product format 687888268
Labeler code 68788
Product ID 68788-8268_ec855832-654a-4cc0-b8a0-3e6fa0f3fab4
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application part341
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-23
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 mg/20mL; mg/20mL
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
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 robafen dm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 200 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 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 1790650 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 68788-8268-1 robafen dm 118 mL in 1 BOTTLE SOLUTION 118 4 68788-8268-1 robafen dm 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8268 ROBAFEN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240806_5b2fd5ce-56ab-491a-81b9-44e35a5d2316.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 1 of 1 · 1 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 68788-8268-1 68788826801 1 BOTTLE in 1 CARTON (68788-8268-1) / 118 mL in 1 BOTTLE 1 bottle 2022-09-23 0000-00-00 No No Current