FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
0363-0533
Requested package NDC
0363-0533-01
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 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
cad5da8c-65a6-44c4-a4c7-38f2c7fe43aaAvailable on FDA.report

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

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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

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 formatDescriptionMarketing 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