FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
0363-0533
11-digit product format
003630533
Labeler code
0363
Product ID
0363-0533_4d721ae5-176b-419f-b29b-a6c138a656f7
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Listing expiration
2027-12-31

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0533-01Mucus Relief DM1 in 1 CARTONTABLET, FILM COATED120
0363-0533-01Mucus Relief DM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020
0363-0533-11Mucus Relief DM1 in 1 CARTONTABLET, FILM COATED120
0363-0533-11Mucus Relief DM60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
0363-0533-25Mucus Relief DM1 in 1 CARTONTABLET, FILM COATED120
0363-0533-25Mucus Relief DM45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4520
0363-0533-32Mucus Relief DM60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
0363-0533-32Mucus Relief DM2 in 1 CARTONTABLET, FILM COATED220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0533-01EA - Each0363-0533cf265359-d038-4be1-b6b2-79f4b256d2f312015-04-03
0363-0533-11EA - Each0363-05334127c256-e923-41b2-9dcb-275131d0502612015-04-03
0363-0533-25EA - Each0363-05335853103b-a2af-46dd-9a5b-5bc68588546712017-11-06
0363-0533-32EA - Each0363-0533adf468a2-38a4-4622-b10e-e902c4e2fefe12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET [WALGREEN CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0533MUCUS RELIEF DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [WALGREEN COMPANY]19Current NDC, Legacy NDC, 8 package rows20250510_cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSNcad5da8c-65a6-44c4-a4c7-38f2c7fe43aa20
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCDcad5da8c-65a6-44c4-a4c7-38f2c7fe43aa20
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSYcad5da8c-65a6-44c4-a4c7-38f2c7fe43aa20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0533-01003630533011 BOTTLE, PLASTIC in 1 CARTON (0363-0533-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-310000-00-00NoNoCurrent
0363-0533-11003630533111 BOTTLE, PLASTIC in 1 CARTON (0363-0533-11) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-310000-00-00NoNoCurrent
0363-0533-25003630533251 BOTTLE in 1 CARTON (0363-0533-25) > 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2005-12-310000-00-00NoNoCurrent
0363-0533-32003630533322 BOTTLE, PLASTIC in 1 CARTON (0363-0533-32) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-310000-00-00NoNoCurrent