FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
0363-9013
11-digit product format
003639013
Labeler code
0363
Product ID
0363-9013_4886d69a-1ee8-cc53-e063-6394a90ade07
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-24
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
2027-12-31
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
Listing expiration
2027-12-31

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
1661740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca53ec26-d167-1780-e053-2a95a90a5b88Available 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
0363-9013-30MUCUS RELIEF DM10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107
0363-9013-30MUCUS RELIEF DM3 in 1 CARTONCAPSULE, LIQUID FILLED37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9013MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20241222_ca53ec26-d167-1780-e053-2a95a90a5b88.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSNca53ec26-d167-1780-e053-2a95a90a5b887
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCDca53ec26-d167-1780-e053-2a95a90a5b887

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9013-30003639013303 BLISTER PACK in 1 CARTON (0363-9013-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2021-08-240000-00-00NoNoCurrent