Mucinex Fast-Max DM Max Honey and Berry Flavor

Product NDC
63824-535
11-digit product format
638240535
Labeler code
63824
Product ID
63824-535_59579ec9-f9da-4397-e063-6394a90ac4a0
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
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
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
Mucinex Fast-Max DM Max Honey and Berry Flavor
Listing expiration
2027-12-31

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
da1f1ef9-a974-4998-8e1d-c1d999596943Available 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
63824-535-66Mucinex Fast-Max DM Max Honey and Berry Flavor180 mL in 1 BOTTLESOLUTION1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-535MUCINEX FAST-MAX DM MAX HONEY AND BERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 1 package rows20240719_da1f1ef9-a974-4998-8e1d-c1d999596943.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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.321430a5-11c9-4d33-8638-5149f601f1bb2026-05-22WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp Incddcc1e78-4ea8-4489-88e7-86ff460164642026-05-21WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HBRAMERISOURCE BERGEN45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e2026-05-21WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC525467fb-510d-0b4b-e063-6294a90acd362026-05-21WarningsExact identifier
application number: M012
Mucinex ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4cee80e5-e412-e832-e063-6394a90aeb902026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRReckitt Benckiser LLC4a9464cf-0c77-23d0-e063-6394a90a62f12026-05-21WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLReckitt Benckiser LLC4ceda68e-c7ce-eb87-e063-6394a90a8ded2026-05-21WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.5258ea3f-87f1-7f86-e063-6394a90ab82f2026-05-21WarningsExact identifier
application number: M012
RELIABLE-1 ANTI DRIP PUMP MISTOXYMETAZOLINE HYDROCHLORIDEReliable 1 Laboratories LLC7df9905d-09aa-4c84-8b6f-6e5ed90df0da2026-05-21WarningsExact identifier
application number: M012
daytime nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Inc80abb6b8-b0d5-4f19-8588-50b8717510bb2026-05-21WarningsExact identifier
application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEFOXYMETAZOLINE HYDROCHLORIDEFAMILY DOLLAR SERVICES INC27163169-54d0-4b6e-94cd-721b29b182492026-05-20WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough FastACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5241b11a-72c8-5e67-e063-6394a90a43532026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC50b140ad-aba2-ce6b-e063-6294a90ae2f82026-05-20WarningsExact identifier
application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4bae240c-70ce-e9c2-e063-6394a90a5f3d2026-05-20WarningsExact identifier
application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC85f7d60b-32ec-4ec2-86ec-f677093bce1d2026-05-20WarningsExact identifier
application number: M012
Chloraseptic Nighttime Sore Throat Hot ReliefACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEPrestige Brands Holdings, Inc.9c13c052-a5d1-43d2-8d29-4ea011a971ac2026-05-20WarningsExact identifier
application number: M012
Cold and Flu Severe, Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationa0bff310-2d35-4a18-815b-8386e44730a22026-05-19WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.61a1beb3-decf-4c8d-a402-93a02ec40a432026-05-19WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC52291746-2bbf-8f3f-e063-6294a90adcfc2026-05-19WarningsExact identifier
application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift KickstartACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCIReckitt Benckiser LLCfdb70793-5dd1-0455-e053-6394a90ac6212026-05-19WarningsExact 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 SolutionPSNda1f1ef9-a974-4998-8e1d-c1d9995969435
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDda1f1ef9-a974-4998-8e1d-c1d9995969435
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYda1f1ef9-a974-4998-8e1d-c1d9995969435
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYda1f1ef9-a974-4998-8e1d-c1d9995969435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-535-6663824053566180 mL in 1 BOTTLE (63824-535-66) 180 ml2020-06-010000-00-00NoNoCurrent