FDA.reportPublic FDA data

Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough

Product NDC
72854-208
11-digit product format
728540208
Labeler code
72854
Product ID
72854-208_51b4e933-f056-2a27-e063-6394a90a839f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
GUAIFENESIN; ACETAMINOPHEN
Active strength
200; 325 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Pressure, Pain and Cough
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/1
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
602617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
350764de-7801-b24e-e063-6394a90ab3c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-208-02Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough2 in 1 POUCHTABLET, FILM COATED22
72854-208-08Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough4 in 1 CARTONTABLET, FILM COATED42
72854-208-08Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough2 in 1 POUCHTABLET, FILM COATED22
72854-208-10Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough10 in 1 BLISTER PACKTABLET, FILM COATED102
72854-208-10Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough1 in 1 CARTONTABLET, FILM COATED12
72854-208-20Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough2 in 1 CARTONTABLET, FILM COATED22
72854-208-20Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-208MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [RB HEALTH (US) LLC]1Current NDC, 7 package rows20250516_350764de-7801-b24e-e063-6394a90ab3c3.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 36 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717656{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) / 1 (acetaminophen 325 MG / guaifenesin 200 MG Oral Tablet) } PackGPCK325b41e1-f8d2-02ee-e063-6394a90aafff7
27176561 daytime (acetaminophen 325 MG / guaiFENesin 200 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSN325b41e1-f8d2-02ee-e063-6394a90aafff7
2549034acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral TabletPSN325b41e1-f8d2-02ee-e063-6394a90aafff7
602617acetaminophen 325 MG / guaiFENesin 200 MG Oral TabletPSN325b41e1-f8d2-02ee-e063-6394a90aafff7
2549034acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD325b41e1-f8d2-02ee-e063-6394a90aafff7
602617acetaminophen 325 MG / guaifenesin 200 MG Oral TabletSCD325b41e1-f8d2-02ee-e063-6394a90aafff7
27176561 daytime (acetaminophen 325 MG / guaifenesin 200 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSY325b41e1-f8d2-02ee-e063-6394a90aafff7
2549034APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSY325b41e1-f8d2-02ee-e063-6394a90aafff7
602617APAP 325 MG / guaifenesin 200 MG Oral TabletSY325b41e1-f8d2-02ee-e063-6394a90aafff7
2549034acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral TabletPSN37dcb0ed-df56-1bec-e063-6394a90a695e2
602617acetaminophen 325 MG / guaiFENesin 200 MG Oral TabletPSN350764de-7801-b24e-e063-6394a90ab3c32
602617acetaminophen 325 MG / guaiFENesin 200 MG Oral TabletPSN37dcb0ed-df56-1bec-e063-6394a90a695e2
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN37dcb0ed-df56-1bec-e063-6394a90a695e2
2549034acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD37dcb0ed-df56-1bec-e063-6394a90a695e2
602617acetaminophen 325 MG / guaifenesin 200 MG Oral TabletSCD37dcb0ed-df56-1bec-e063-6394a90a695e2
602617acetaminophen 325 MG / guaifenesin 200 MG Oral TabletSCD350764de-7801-b24e-e063-6394a90ab3c32
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD37dcb0ed-df56-1bec-e063-6394a90a695e2
2549034APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSY37dcb0ed-df56-1bec-e063-6394a90a695e2
602617APAP 325 MG / guaifenesin 200 MG Oral TabletSY37dcb0ed-df56-1bec-e063-6394a90a695e2
602617APAP 325 MG / guaifenesin 200 MG Oral TabletSY350764de-7801-b24e-e063-6394a90ab3c32
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY37dcb0ed-df56-1bec-e063-6394a90a695e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72854-208-02728540208022 TABLET, FILM COATED in 1 POUCH (72854-208-02) 2025-05-01NoNoCurrent
72854-208-08728540208084 POUCH in 1 CARTON (72854-208-08) / 2 TABLET, FILM COATED in 1 POUCH4 pouch2025-05-01NoNoCurrent
72854-208-10728540208101 BLISTER PACK in 1 CARTON (72854-208-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-05-01NoNoCurrent
72854-208-20728540208202 BLISTER PACK in 1 CARTON (72854-208-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2025-05-01NoNoCurrent