FDA.reportPublic FDA data

MUCUS RELIEF DM

Product NDC
41226-280
11-digit product format
412260280
Labeler code
41226
Product ID
41226-280_f273d4b6-65d4-a18b-e053-2995a90a1ec4
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBR/GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
KROGER COMPANY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-03
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

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
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
813baf42-edb0-33a9-e053-2a91aa0a8599Available 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
41226-280-03MUCUS RELIEF DM30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-280MUCUS RELIEF DM (DEXTROMETHORPHAN HBR/GUAIFENESIN) TABLET [KROGER COMPANY]2Current NDC, Legacy NDC, 1 package rows20190603_813baf42-edb0-33a9-e053-2a91aa0a8599.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 60 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCbab078bb-f6b0-4394-84de-92b2c582b5da2026-01-12WarningsExact identifier
application number: M012
Nasal Decongestant PE Non-Drowsy Maximum StrengthPHENYLEPHRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d2026-01-12WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
application number: M012
GUAIFENESIN 400MG CAPLETSGUAIFENESINGendose Pharmaceuticals, LLCe7b82ec7-ef23-50c1-e053-2a95a90a662f2026-01-10WarningsExact identifier
application number: M012
Daytime Cold and FluDAYTIME COLD AND FLUAllegiant Health69ed2da0-16b2-49eb-91b4-cc5cf328c8172026-01-09WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutionsa5809774-ed52-4f54-b48e-888631e0223d2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutions5767f546-a751-4583-a8b7-971175c27ef02026-01-09WarningsExact identifier
application number: M012
Thompson Cough and Cold Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,Thompsone77725b1-15da-35bd-e053-2a95a90ad6ba2026-01-08WarningsExact identifier
application number: M012
Mucosan Childrens Multi-Symptom GrapeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.266c8cce-cdf9-557d-e063-6394a90a9bc32026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom HoneyDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.2669c620-ab70-abaa-e063-6394a90a58e72026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom CherryDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26b8c06d-4a72-3979-e063-6394a90a96d72026-01-08WarningsExact identifier
application number: M012
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
application number: M012
Mucosan Severe Multi-SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.26a69342-f65f-cb46-e063-6394a90ade102026-01-08WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non DrowsyASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a355d987-77ce-9e32-e053-2995a90a64312026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc60af2f-83cb-99ea-e053-6394a90a0b3b2026-01-08WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN813baf42-edb0-33a9-e053-2a91aa0a85992
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD813baf42-edb0-33a9-e053-2a91aa0a85992
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY813baf42-edb0-33a9-e053-2a91aa0a85992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-280-034122602800330 TABLET in 1 BOTTLE (41226-280-03) 30 tablet2019-06-030000-00-00NoNoCurrent