FDA.reportPublic FDA data

Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus

Product NDC
72854-243
11-digit product format
728540243
Labeler code
72854
Product ID
72854-243_51a483c2-9a2c-2c7a-e063-6294a90aaa3a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Triprolidine Hydrochloride
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
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 Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup
2549037Internal RxNorm lookup
2560237Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c746953f-4b7d-4e2a-9b85-96bd6901f517Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
72854-243-102023-05-11Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-202023-05-11Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-402023-05-11Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-102023-01-30Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-202023-01-30Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength
72854-243-402023-01-30Mucinex® Sinus-Max® Day Pressure, Pain & Cough and Mucinex Nightshift Night Sinus Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-243-10Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 CARTONKIT15
72854-243-10Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15
72854-243-20Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength2 in 1 CARTONKIT25
72854-243-20Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15
72854-243-40Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength4 in 1 CARTONKIT45
72854-243-40Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night SinusMaximum Strength1 in 1 KITKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-243-10EA - Each72854-243aebd8ba4-a7b5-468b-8846-20ca216b2b8612021-10-08
72854-243-20EA - Each72854-2439ca63b05-8d66-4da3-87d9-9aab1fe3324812021-10-08
72854-243-40EA - Each72854-24350de03e3-1278-413a-8cb8-acf7f492f34512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-243MUCINEX SINUS-MAX DAY PRESSURE, PAIN AND COUGH AND MUCINEX NIGHTSHIFT NIGHT SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]4Current NDC, Legacy NDC, 6 package rows20241225_c746953f-4b7d-4e2a-9b85-96bd6901f517.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 110 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC0bb006f6-c360-4cd5-81e9-0776d99d79e82025-07-08WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.026e530f-e133-4f20-bac5-354fbb647c9e2025-07-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCf59016f3-a8f8-4c95-9414-01440f0574d92025-07-08WarningsExact identifier
application number: M012
ACTINEL PEDIATRICDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLC6bb92d74-4893-40b8-af58-eb307155e8762025-07-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)776b7c67-56c7-420c-82b2-9a176d9983962025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC847014ab-86ae-40c5-8e7f-f1ddea14f1b32025-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGCabinet Health, Inc.26a51b0e-039c-663c-e063-6394a90ad3842025-07-07WarningsExact identifier
application number: M012
EZ Nite SleepDIPHENHYDRAMINE HCLSafeway, Inc.21a68c60-3005-43bb-8ec5-7982239c93f82025-07-07WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC8188b66a-5405-4e62-bde6-63ebc1f22b162025-07-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560237{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } PackGPCKc746953f-4b7d-4e2a-9b85-96bd6901f5175
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackPSNc746953f-4b7d-4e2a-9b85-96bd6901f5175
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNc746953f-4b7d-4e2a-9b85-96bd6901f5175
2549037acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral TabletPSNc746953f-4b7d-4e2a-9b85-96bd6901f5175
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDc746953f-4b7d-4e2a-9b85-96bd6901f5175
2549037acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCDc746953f-4b7d-4e2a-9b85-96bd6901f5175
25602371 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) PackSYc746953f-4b7d-4e2a-9b85-96bd6901f5175
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYc746953f-4b7d-4e2a-9b85-96bd6901f5175
2549037APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSYc746953f-4b7d-4e2a-9b85-96bd6901f5175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-243-10728540243101 KIT in 1 CARTON (72854-243-10) / 1 KIT in 1 KIT * 6 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK1 kit2021-07-010000-00-00NoNoCurrent
72854-243-20728540243202 KIT in 1 CARTON (72854-243-20) / 1 KIT in 1 KIT * 6 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK2 kit2021-07-010000-00-00NoNoCurrent
72854-243-40728540243404 KIT in 1 CARTON (72854-243-40) / 1 KIT in 1 KIT * 6 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK4 kit2021-07-010000-00-00NoNoCurrent