Home NDC 69842-059 Maximum Strength Mucus DM Extended Release
Product NDC 69842-059
11-digit product format 698420059
Labeler code 69842
Product ID 69842-059_9d11e2a3-e3be-4bf8-b556-b8af9ee9c234
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan HBr
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler CVS Pharmacy, Inc.
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.
Product history page 3 of 3 · 82 observed 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206941-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 30MG;600MG TABLET, EXTENDED RELEASE / ORAL 2017-03-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206941-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 60MG;1.2GM TABLET, EXTENDED RELEASE / ORAL 2017-03-17 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Maximum Strength Mucus DM Extended Release
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69842-059-10 Maximum Strength Mucus DM Extended Release 7 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 7 8 69842-059-10 Maximum Strength Mucus DM Extended Release 6 in 1 CARTON TABLET, EXTENDED RELEASE 6 8 69842-059-65 Maximum Strength Mucus DM Extended Release 7 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 7 8 69842-059-65 Maximum Strength Mucus DM Extended Release 2 in 1 CARTON TABLET, EXTENDED RELEASE 2 8 69842-059-70 Maximum Strength Mucus DM Extended Release 4 in 1 CARTON TABLET, EXTENDED RELEASE 4 8 69842-059-70 Maximum Strength Mucus DM Extended Release 7 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 7 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-059 MAXIMUM STRENGTH MUCUS DM EXTENDED RELEASE (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20240210_5ea560d1-6443-4271-842c-7801fc6a6043.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 2 · 32 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 69842-059-10 69842005910 6 BLISTER PACK in 1 CARTON (69842-059-10) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 6 blister pack 2017-03-17 0000-00-00 No No Current 69842-059-65 69842005965 2 BLISTER PACK in 1 CARTON (69842-059-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 blister pack 2017-03-17 0000-00-00 No No Current 69842-059-70 69842005970 4 BLISTER PACK in 1 CARTON (69842-059-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 4 blister pack 2017-03-17 0000-00-00 No No Current