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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-05330363-0533-11DDiscontinued by firm2026-08-17
excluded packagepackage0363-05330363-0533-25DDiscontinued by firm2026-08-17

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 · 23 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050363-0533-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0533-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0533-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0533-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310363-0533-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0533-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280363-0533-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0533-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210363-0533-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0533-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100363-0533-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0533-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310363-0533-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0533-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200363-0533-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0533-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100363-0533-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0533-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080363-0533-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0533-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030363-0533-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0533-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090363-0533-25557ba5c1ecfa…9c80585c8c6e…

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 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact 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 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