FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
41250-533
11-digit product format
412500533
Labeler code
41250
Product ID
41250-533_462149db-00f4-4a0a-b9c9-1b63c07f2db6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-31
Marketing end
2027-11-30
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
Current FDA listing
Yes

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
Mucus Relief DM

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal 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
8ed5b802-a26e-45b4-a696-bc64dbac4733Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-533-11Mucus Relief DM1 in 1 CARTONTABLET, FILM COATED116
41250-533-11Mucus Relief DM60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUIAFENESIN) TABLET, FILM COATED [MEIJER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-533MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]15Current NDC, Legacy NDC, 2 package rows20241206_8ed5b802-a26e-45b4-a696-bc64dbac4733.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 178 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN8ed5b802-a26e-45b4-a696-bc64dbac473316
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD8ed5b802-a26e-45b4-a696-bc64dbac473316
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY8ed5b802-a26e-45b4-a696-bc64dbac473316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-533-11412500533111 BOTTLE, PLASTIC in 1 CARTON (41250-533-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-312027-11-30NoNoCurrent