Home NDC 67091-314 Mucus Relief DM Expectorant and Cough Suppressant
Product NDC 67091-314
11-digit product format 670910314
Labeler code 67091
Product ID 67091-314_d794e7e6-3681-4329-9ab8-22de9e94debd
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 30; 600 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 30 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 600 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 1298324 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-314-20 Mucus Relief DM Expectorant and Cough Suppressant 2 in 1 CARTON TABLET, EXTENDED RELEASE 2 5 67091-314-20 Mucus Relief DM Expectorant and Cough Suppressant 10 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-314 MUCUS RELIEF DM EXPECTORANT AND COUGH SUPPRESSANT (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [WINCO FOODS, LLC.] 5 Current NDC, Legacy NDC, 2 package rows 20231202_e7e16bab-a7aa-4911-9a29-0c986b26da67.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 67091-314-20 67091031420 2 BLISTER PACK in 1 CARTON (67091-314-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 blister pack 2017-03-17 0000-00-00 No No Current