FDA.reportPublic FDA data

Maximum Strength Mucus Relief DM

Product NDC
49035-839
11-digit product format
490350839
Labeler code
49035
Product ID
49035-839_42354dff-5596-9b10-e063-6294a90a74bd
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Wal-Mart Stores,Inc.,
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
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
2026-12-31
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
Maximum Strength Mucus Relief DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

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
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a748d5ab-901c-47bb-8437-997542ecebfeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
49035-839-06Maximum Strength Mucus Relief DM180 mL in 1 BOTTLELIQUID1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-839-06ML - Milliliter49035-839e223da5f-92d5-4967-b915-8260ef221b6212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-839MAXIMUM STRENGTH MUCUS RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [WAL-MART STORES,INC.,]7Current NDC, Legacy NDC, 1 package rows20241116_a748d5ab-901c-47bb-8437-997542ecebfe.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 145 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Fast Acting NasalPHENYLEPHRINE HYDROCHLORIDEAmerican Sales Company95b22dce-ef54-4ab5-9cc3-0e1cefa09ec52024-10-24WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Consortium, LLC8cb0d0c8-c565-4c5a-97c5-8250a67e23a82024-10-24WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc0d07a534-c67f-4041-a07c-ed7f68dfc4262024-10-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.90977b39-8ced-46bf-9d06-15306bce9b352024-10-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb2024-10-23WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2325f33-e4e4-1269-e053-2995a90ab4ac2024-10-23WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a8240d98-f0b0-3ded-e053-2a95a90a5cf92024-10-23WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a82401f5-65b1-11e9-e053-2a95a90a499e2024-10-23WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.a823db21-4863-45a6-e053-2995a90ab8e62024-10-23WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e2346d0c-75cf-974c-e053-2a95a90a28572024-10-23WarningsExact identifier
application number: M012
Cold Multi-Symptom NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEMarc Glassman, Inc.ce573785-f77d-4314-9b7a-ef3f1f4f34d82024-10-23WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a3dcc-45b4-4093-e053-2995a90a3b142024-10-23WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMARC GLASSMAN, INC.e41a7cc5-bd0e-b92b-e053-2995a90af50a2024-10-23WarningsExact identifier
application number: M012
NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Company1cd26a6a-4b50-4610-9fc8-278545d77f182024-10-23WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyc5dd40e5-b4e2-4963-9a53-b71da1ed55102024-10-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter832eb36c-21c6-46d7-b1f8-ab8b6f1e501e2024-10-22WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc9d82968-b2ec-2f4b-e053-2a95a90a7f0c2024-10-22WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterb9d9ab99-44b1-455f-a29a-95c193a4808e2024-10-22WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb96c376e-578f-1124-e053-2a95a90acbb42024-10-22WarningsExact identifier
application number: M012
Tukol Honey Daytime and Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbccc11d2-d227-4cbb-b0fc-ac6abb6dce572024-10-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNa748d5ab-901c-47bb-8437-997542ecebfe8
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa748d5ab-901c-47bb-8437-997542ecebfe8
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYa748d5ab-901c-47bb-8437-997542ecebfe8
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYa748d5ab-901c-47bb-8437-997542ecebfe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-839-0649035083906180 mL in 1 BOTTLE (49035-839-06) 180 ml2018-05-010000-00-00NoNoCurrent