FDA.reportPublic FDA data

Mucinex Fast-Max

Product NDC
63824-019
11-digit product format
638240019
Labeler code
63824
Product ID
63824-019_51b429cd-50ec-4059-e063-6294a90a40de
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
2012-07-18
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex Fast-Max
Brand name suffix
DM Max
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
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53855190-7124-8179-f018-e792f7c27f28Product name120140508
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76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
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d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-019-22Mucinex Fast-MaxDM Max180 mL in 1 BOTTLESOLUTION18013
63824-019-22Mucinex Fast-MaxDM Max2 in 1 CARTONSOLUTION213
63824-019-66Mucinex Fast-MaxDM Max180 mL in 1 BOTTLESOLUTION18013
63824-019-66Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL400 mg in 20mL6
63824-019-66Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu180 mL in 1 BOTTLESOLUTION180 mL400 mg in 20mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-019-66ML - Milliliter63824-019de56a7cd-8891-4cd0-ae71-eaa5dcedbeae12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
guaifenesinACTIVE INGREDIENT495W7451VQMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
dextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
guaifenesinACTIVE MOIETY495W7451VQMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOAMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92MUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
sorbitolINACTIVE INGREDIENT506T60A25RMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4MUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
waterINACTIVE INGREDIENT059QF0KO0RMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEEMUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-019MUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RB HEALTH (US) LLC]11Current NDC, Legacy NDC, 3 package rows20241004_6a8cdcad-4881-49b8-a3f1-2c1574300d18.zip
63824-019MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTSHIFT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]4Current NDC, Legacy NDC20241222_2ed3c844-0532-40d9-beba-738d196de34d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN6a8cdcad-4881-49b8-a3f1-2c1574300d1813
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6a8cdcad-4881-49b8-a3f1-2c1574300d1813
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY6a8cdcad-4881-49b8-a3f1-2c1574300d1813
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6a8cdcad-4881-49b8-a3f1-2c1574300d1813
2287760{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK3ba2cc08-acad-79a8-e063-6394a90af17f6
22877601 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSN3ba2cc08-acad-79a8-e063-6394a90af17f6
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN3ba2cc08-acad-79a8-e063-6394a90af17f6
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN3ba2cc08-acad-79a8-e063-6394a90af17f6
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD3ba2cc08-acad-79a8-e063-6394a90af17f6
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3ba2cc08-acad-79a8-e063-6394a90af17f6
22877601 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSY3ba2cc08-acad-79a8-e063-6394a90af17f6
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY3ba2cc08-acad-79a8-e063-6394a90af17f6
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY3ba2cc08-acad-79a8-e063-6394a90af17f6
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY3ba2cc08-acad-79a8-e063-6394a90af17f6
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3ba2cc08-acad-79a8-e063-6394a90af17f6
2287760{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } PackGPCK2ed3c844-0532-40d9-beba-738d196de34d5
22877601 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) PackPSN2ed3c844-0532-40d9-beba-738d196de34d5
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN2ed3c844-0532-40d9-beba-738d196de34d5
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN2ed3c844-0532-40d9-beba-738d196de34d5
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD2ed3c844-0532-40d9-beba-738d196de34d5
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2ed3c844-0532-40d9-beba-738d196de34d5
22877601 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) PackSY2ed3c844-0532-40d9-beba-738d196de34d5
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY2ed3c844-0532-40d9-beba-738d196de34d5
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY2ed3c844-0532-40d9-beba-738d196de34d5
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY2ed3c844-0532-40d9-beba-738d196de34d5
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2ed3c844-0532-40d9-beba-738d196de34d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-019-22638240019222 BOTTLE in 1 CARTON (63824-019-22) > 180 mL in 1 BOTTLE2 bottle2020-07-010000-00-00NoNoCurrent
63824-019-6663824001966180 mL in 1 BOTTLE (63824-019-66) 180 ml2012-07-180000-00-00NoNoCurrent