FDA.reportPublic FDA data

Mucus Relief DM Cough

Product NDC
70000-0278
11-digit product format
700000278
Labeler code
70000
Product ID
70000-0278_63b596e2-a30f-4587-86ed-f0fc724b2f7e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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 Relief DM Cough
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1147685

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0278-1Mucus Relief DM CoughMaximum Strength12 in 1 BLISTER PACKTABLET, FILM COATED1215
70000-0278-1Mucus Relief DM CoughMaximum Strength2 in 1 CARTONTABLET, FILM COATED215
70000-0278-2Mucus Relief DM CoughMaximum Strength1 in 1 CARTONTABLET, FILM COATED115
70000-0278-2Mucus Relief DM CoughMaximum Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0278-1EA - Each70000-02781feec0f8-58be-4320-91ab-17255b56ad9d12017-11-06
70000-0278-2EA - Each70000-02785e1be60d-6f30-4b4b-b56d-585802e98c1112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0278MUCUS RELIEF DM COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]14Current NDC, Legacy NDC, 4 package rows20240511_6304a581-9238-4539-b157-293fc05c173e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN6304a581-9238-4539-b157-293fc05c173e15
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD6304a581-9238-4539-b157-293fc05c173e15
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY6304a581-9238-4539-b157-293fc05c173e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0278-1700000278012 BLISTER PACK in 1 CARTON (70000-0278-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-12-310000-00-00NoNoCurrent
70000-0278-2700000278021 BOTTLE in 1 CARTON (70000-0278-2) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2005-12-312022-12-04NoNoCurrent