FDA.reportPublic FDA data

MUCOSA DM

Product NDC
49483-280
11-digit product format
494830280
Labeler code
49483
Product ID
49483-280_2d9cef2f-22cd-ed8e-e063-6394a90ad8a8
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN DEXTROMETHORPHAN
Dosage form
TABLET
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-17
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
MUCOSA DM
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-280-002025-02-10C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-062025-02-10C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-202025-02-10C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-002025-01-30C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-062025-01-30C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets
49483-280-202025-01-30C16284748780-12cef2736-9887-d83d-e063-dadaa90ab31f280R Timely 49483-280 Dextromethorphan HBr 20 mg and Guaifenesin 400 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-280-00MUCOSA DM100000 in 1 CARTONTABLET1000004
49483-280-06MUCOSA DM60 in 1 BOTTLE, PLASTICTABLET604
49483-280-20MUCOSA DM200 in 1 BOTTLETABLET2004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-280-06EA - Each49483-280b93edcce-7cd8-4ba1-886f-a2dfc6db3b3c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-280MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN) TABLET [TIME CAP LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20250212_62c1f4aa-6571-414c-9a58-31e107b7db97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN62c1f4aa-6571-414c-9a58-31e107b7db974
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD62c1f4aa-6571-414c-9a58-31e107b7db974
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY62c1f4aa-6571-414c-9a58-31e107b7db974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-280-0049483028000100000 TABLET in 1 CARTON (49483-280-00) 100000 tablet2018-12-170000-00-00NoNoCurrent
49483-280-064948302800660 TABLET in 1 BOTTLE, PLASTIC (49483-280-06) 60 tablet2018-12-170000-00-00NoNoCurrent
49483-280-2049483028020200 TABLET in 1 BOTTLE (49483-280-20) 200 tablet2023-09-15NoNoCurrent