FDA.reportPublic FDA data

Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain

Product NDC
63824-266
11-digit product format
638240266
Labeler code
63824
Product ID
63824-266_5dcc75a5-5a70-a8e1-e063-6394a90a8050
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
GUAIFENESIN400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/20mL

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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-11Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-02-11Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-01-31Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain
2020-01-31Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-266-66Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain180 mL in 1 BOTTLESOLUTION1807
63824-266-66Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus180 mL in 1 BOTTLESOLUTION180 mL650 mg in 20mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-266MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]6Current NDC, Legacy NDC, 1 package rows20241220_cea08797-1d53-4434-be1a-144f2ded5f9d.zip
63824-266MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN AND MUCINEX NIGHTSHIFT SINUS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC20241220_75c6b92f-219f-4740-bb72-c02a927a21ff.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 16 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLWinCo Foods, LLC2cbf27b6-217c-46d8-89c9-e46f3668f0022026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)d86d53cd-75ce-4c40-83cb-ada9b77a76f62026-07-17WarningsExact identifier
application number: M012
LEADER Multi Symptom Flu Relief Daytime Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER2212cf9e-6944-4922-b5b5-1373cf10b2e12026-07-16WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATECVS PHARMACY06756130-1608-4ae6-9772-95a4549853a12026-07-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLOld East Main Co.7855033e-6a12-4cd8-b0a2-c5d69018d1172026-07-16Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsExact identifier
application number: M012
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC522e1e7f-98ed-c475-e063-6294a90a622c2026-07-16WarningsExact identifier
application number: M012
LEADER MS Flu Relief NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d2026-07-16WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC1bf4cd96-5800-434d-a0dc-e84c759ebb332026-07-16WarningsExact identifier
application number: M012
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINWalgreens2ace231a-94c4-479d-bb26-454bd07b207b2026-07-16WarningsExact identifier
application number: M012
LEADER No DripALLERGY SINUS NASAL MISTCARDINAL HEALTH 110, LLC. DBA LEADERe7b2c1c1-6250-4af3-b131-22aced2b23d52026-07-16WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93fe6d-ee21-e323-e063-6394a90a61bf2026-07-15WarningsExact identifier
application number: M012
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association1f93c815-63c7-bfe0-e063-6394a90ab4a52026-07-15WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leader0fad61d8-4393-47ec-9ff6-7df5be761f5b2026-07-14WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLRite Aid Corporation211c4273-3b2c-4169-b9c6-7a87903e77cd2026-07-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116568acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNcea08797-1d53-4434-be1a-144f2ded5f9d7
1116568acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDcea08797-1d53-4434-be1a-144f2ded5f9d7
1116568acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYcea08797-1d53-4434-be1a-144f2ded5f9d7
1116568acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYcea08797-1d53-4434-be1a-144f2ded5f9d7
1116568APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYcea08797-1d53-4434-be1a-144f2ded5f9d7
1116568APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYcea08797-1d53-4434-be1a-144f2ded5f9d7
2397132{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK75c6b92f-219f-4740-bb72-c02a927a21ff4
23971321 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) PackPSN75c6b92f-219f-4740-bb72-c02a927a21ff4
2173662acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN75c6b92f-219f-4740-bb72-c02a927a21ff4
2173662acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD75c6b92f-219f-4740-bb72-c02a927a21ff4
23971321 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) / 1 daytime (acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) PackSY75c6b92f-219f-4740-bb72-c02a927a21ff4
2173662acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
2173662acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
2173662APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4
1116568APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY75c6b92f-219f-4740-bb72-c02a927a21ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-266-6663824026666180 mL in 1 BOTTLE (63824-266-66) 180 ml2018-03-010000-00-00NoNoCurrent