Home NDC 67091-315 Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength
Product NDC 67091-315
11-digit product format 670910315
Labeler code 67091
Product ID 67091-315_b6b1e266-1ff8-4a43-b9b5-dfe69ac5559b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan HBr
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Winco Foods, LLC.
Application ANDA206941
Marketing category ANDA
Marketing start 2017-03-17
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 60; 1200 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
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206941-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30MG;600MG TABLET, EXTENDED RELEASE / ORAL 2017-03-17 A206941-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60MG;1.2GM TABLET, EXTENDED RELEASE / ORAL 2017-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A206941-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 30MG;600MG TABLET, EXTENDED RELEASE / ORAL 2017-03-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A206941-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 60MG;1.2GM TABLET, EXTENDED RELEASE / ORAL 2017-03-17 a50c72e98297…
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. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 32 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 60 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 1200 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 1099074 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 67091-315-14 Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength 2 in 1 CARTON TABLET, EXTENDED RELEASE 2 5 67091-315-14 Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength 7 in 1 CARTON TABLET, EXTENDED RELEASE 7 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-315 MUCUS RELIEF DM EXPECTORANT AND COUGH SUPPRESSANT MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [WINCO FOODS, LLC.] 5 Current NDC, Legacy NDC, 2 package rows 20231202_ac1c8633-4064-4e2f-9b43-4ae9bdd1a427.zip
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 67091-315-14 67091031514 2 CARTON in 1 CARTON (67091-315-14) / 7 TABLET, EXTENDED RELEASE in 1 CARTON 2 carton 2017-03-17 0000-00-00 No No Current