FDA.reportPublic FDA data

Mucinex Fast-Max

Product NDC
63824-237
11-digit product format
638240237
Labeler code
63824
Product ID
63824-237_51a49ad7-95b0-5066-e063-6294a90ab8a7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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
Brand name suffix
Cold, Flu and Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7c18e95-8d7b-4550-9a20-fc704a114adbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63824-237-202020-09-08Mucinex® Fast-Max ® Cold, Flu & Sore Throat
63824-237-442020-09-08Mucinex® Fast-Max ® Cold, Flu & Sore Throat
63824-237-202020-07-22Mucinex® Fast-Max ® Cold, Flu & Sore Throat
63824-237-442020-07-22Mucinex® Fast-Max ® Cold, Flu & Sore Throat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-237-20Mucinex Fast-MaxCold, Flu and Sore Throat2 in 1 CARTONTABLET, COATED29
63824-237-20Mucinex Fast-MaxCold, Flu and Sore Throat10 in 1 BLISTER PACKTABLET, COATED109
63824-237-21Mucinex Fast-MaxCold, Flu and Sore Throat10 in 1 BLISTER PACKTABLET, COATED109
63824-237-21Mucinex Fast-MaxCold, Flu and Sore Throat2 in 1 CARTONTABLET, COATED29
63824-237-44Mucinex Fast-MaxCold, Flu and Sore Throat4 in 1 CARTONTABLET, COATED49
63824-237-72Mucinex Fast-MaxCold, Flu and Sore Throat2 in 1 POUCHTABLET, COATED29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-237MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC]8Current NDC, Legacy NDC, 6 package rows20241222_d7c18e95-8d7b-4550-9a20-fc704a114adb.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 105 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012
Ephedrine SulfateEPHEDRINE SULFATEWalgreen Companydc0072f9-7111-1af0-e053-2a95a90aed562025-09-04WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS Pharmacy, Inc31aa77e0-cfdb-57a8-e063-6394a90af98c2025-09-04WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATECVS Pharmacy, Inc.4bb70a55-de44-3dc1-e054-00144ff8d46c2025-09-04WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de637b1-3402-db86-e063-6294a90ac9812025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCf4a9cfec-0725-8f4a-e053-2995a90a1b4a2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de65c99-6c2d-3650-e063-6394a90aa98c2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEMedical Group Care LLCf4a9d879-4736-4f63-e053-2995a90adeba2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de66240-441c-00ad-e063-6294a90a4a052025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCff99c57a-e06a-69d3-e053-6394a90a67752025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de7ace0-e389-b751-e063-6394a90ab4e92025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNd7c18e95-8d7b-4550-9a20-fc704a114adb9
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDd7c18e95-8d7b-4550-9a20-fc704a114adb9
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYd7c18e95-8d7b-4550-9a20-fc704a114adb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-237-20638240237202 BLISTER PACK in 1 CARTON (63824-237-20) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2017-10-010000-00-00NoNoCurrent
63824-237-21638240237212 BLISTER PACK in 1 CARTON (63824-237-21) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-10-010000-00-00NoNoCurrent
63824-237-44638240237444 POUCH in 1 CARTON (63824-237-44) / 2 TABLET, COATED in 1 POUCH (63824-237-72) 4 pouch2017-12-200000-00-00NoNoCurrent
63824-237-72638240237722 in 1 POUCHHistorical