FDA.reportPublic FDA data

Mucus DM Extended Release

Product NDC
69842-057
11-digit product format
698420057
Labeler code
69842
Product ID
69842-057_b793ab0a-5809-46d0-b57a-7ad03b29f959
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus DM Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/1
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1298324

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-057-112024-01-30C16284748780-11030e365-3523-111a-e063-dadaa90a10e2Drug Facts
69842-057-672024-01-30C16284748780-11030e365-3523-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-057-11Mucus DM Extended Release4 in 1 CARTONTABLET, EXTENDED RELEASE49
69842-057-11Mucus DM Extended Release10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
69842-057-67Mucus DM Extended Release10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE109
69842-057-67Mucus DM Extended Release2 in 1 CARTONTABLET, EXTENDED RELEASE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-057-11EA - Each69842-057e80319d7-78a1-463d-9cd8-4846d1e363f312022-07-06
69842-057-67EA - Each69842-057f1ea1f61-6e39-4f6a-b063-e0e354892ab312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-057MUCUS DM EXTENDED RELEASE (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.]8Current NDC, Legacy NDC, 4 package rows20240210_2aa1889f-bb76-4e70-81b5-c25c4ebab113.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN2aa1889f-bb76-4e70-81b5-c25c4ebab1139
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD2aa1889f-bb76-4e70-81b5-c25c4ebab1139
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY2aa1889f-bb76-4e70-81b5-c25c4ebab1139

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-057-11698420057114 BLISTER PACK in 1 CARTON (69842-057-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2017-03-170000-00-00NoNoCurrent
69842-057-67698420057672 BLISTER PACK in 1 CARTON (69842-057-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-03-170000-00-00NoNoCurrent