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
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400; 20 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-280-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-280-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-280-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-280-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-280-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-280-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-280-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-280-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-280-000efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MUCOSA DM
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62c1f4aa-6571-414c-9a58-31e107b7db97Available on FDA.report

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#

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 [BRYANT RANCH PREPACK]1000
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
GUAIFENESINACTIVE MOIETY495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK]1000
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS 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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS 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
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS 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

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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012

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