FDA.reportPublic FDA data

Mucinex Fast-Max

Product NDC
63824-515
11-digit product format
638240515
Labeler code
63824
Product ID
63824-515_51b45cdb-42b6-7a6f-e063-6294a90a5039
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
200; 5; 10 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63824-51563824-515-01DDiscontinued by firm2026-10-28

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
Severe Congestion and Cough
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1372652Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1991d5ee-fc90-4070-8965-cd6f4abc45cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-515-01Mucinex Fast-MaxSevere Congestion and Cough10 in 1 BLISTER PACKTABLET, FILM COATED108
63824-515-01Mucinex Fast-MaxSevere Congestion and Cough2 in 1 CARTONTABLET, FILM COATED28
63824-515-20Mucinex Fast-MaxSevere Congestion and Cough5 in 1 BLISTER PACKTABLET, FILM COATED58
63824-515-20Mucinex Fast-MaxSevere Congestion and Cough4 in 1 CARTONTABLET, FILM COATED48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-515MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [RB HEALTH (US) LLC]7Current NDC, Legacy NDC, 4 package rows20231202_1991d5ee-fc90-4070-8965-cd6f4abc45cf.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 170 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLA-S Medication Solutionse1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd2024-01-08WarningsExact identifier
application number: M012
AXIM DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC0e7424ea-461f-5ead-e063-6294a90a41b62024-01-05WarningsExact identifier
application number: M012
AXIM Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC0e740063-80d5-c48b-e063-6394a90a3b302024-01-05WarningsExact identifier
application number: M012
AXIM DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC0e742e10-daea-6443-e063-6294a90ab5af2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3c3e0dc8-cddd-4f46-9b68-19bac00c07cc2024-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLA-S Medication Solutionsfa12a5a8-bf2d-4991-9d54-9c519e8e04cd2024-01-04WarningsExact identifier
application number: M012
NASAL DECONGESTANT PE 10mgPHENYLPHRINE HCLYYBA CORP05824fc4-ef3f-4ebb-b601-252f76ad60ef2024-01-03WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP5943d975-77e4-4cbd-b2d9-d699052fe82a2024-01-01WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEProficient Rx LPac79a7dd-c26e-47d2-8fb9-768d2d09e5072024-01-01WarningsExact identifier
application number: M012
Oxymethazoline HCLOXYMETHAZOLINE HCLProficient Rx LP96883e5f-18b5-4c1c-b984-756cb86be6ff2024-01-01WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLProficient Rx LP6e91b9c3-57e8-488b-ac70-d863cdf9d6e82024-01-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LP9e067482-8735-4476-a82e-438dd24d42892024-01-01WarningsExact identifier
application number: M012
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDEAptaPharma Inc.8a4c55d0-c472-4e89-9fdb-17ecf0af48562023-12-30WarningsExact identifier
application number: M012
XL-3 XtremeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAptaPharma Inc.dff79e0b-edf0-4dd3-a722-fd9beecd62932023-12-30WarningsExact identifier
application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSalado Sales, Inc.e25727d0-7dd7-4ef5-b064-7938679f075f2023-12-29WarningsExact identifier
application number: M012
Maximum Strength DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E Bbb56d09d-ecb0-469e-a16f-f9f1a48942a82023-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1991d5ee-fc90-4070-8965-cd6f4abc45cf8
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1991d5ee-fc90-4070-8965-cd6f4abc45cf8
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSY1991d5ee-fc90-4070-8965-cd6f4abc45cf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-515-01638240515012 BLISTER PACK in 1 CARTON (63824-515-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-08-010000-00-00NoNoCurrent
63824-515-20638240515204 BLISTER PACK in 1 CARTON (63824-515-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2024-01-01NoNoCurrent