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 13 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
application number: M012
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
application number: M012
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsExact identifier
application number: M012
RIGHT REMEDIES Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrive Pharmaceuticals Inc.51c4dcfb-8725-d547-e063-6394a90ac04c2026-07-31WarningsExact identifier
application number: M012
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
application number: M012
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
application number: M012
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
application number: M012
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsExact identifier
application number: M012
Sinus Relief Daytime, NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation352b89b5-6995-4873-a103-e8f89074fdc92026-07-30WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Incf1e83e43-011c-4470-bd55-fb2818a9fc842026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
TOPCARE NITE TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d2026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact 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