FDA.reportPublic FDA data

Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu

Product NDC
72854-241
11-digit product format
728540241
Labeler code
72854
Product ID
72854-241_51a46d2a-42d2-29f7-e063-6294a90ae3be
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and 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 Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu
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
dbdafbb4-f3c9-4042-b867-db4d06dc3d61Available 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
72854-241-102023-06-15Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength
72854-241-202023-06-15Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength
72854-241-402023-06-15Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength
72854-241-102023-01-30Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength
72854-241-202023-01-30Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength
72854-241-402023-01-30Mucinex® Fast-Max ® Day Cold & Flu and Mucinex Nightshift Night Severe Cold & Flu Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-241-10Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 CARTONKIT14
72854-241-10Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT14
72854-241-20Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT14
72854-241-20Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength2 in 1 CARTONKIT24
72854-241-40Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength4 in 1 CARTONKIT44
72854-241-40Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and FluMaximum Strength1 in 1 KITKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-241-10EA - Each72854-2419aad4a93-c0a1-4bb9-a42e-23d96fa2ad5b12021-06-02
72854-241-20EA - Each72854-241fe70fed1-1535-482f-8c3e-86b65d0b6f5c12021-06-02
72854-241-40EA - Each72854-241189bdcec-3472-4557-a8b5-1c9bd58dad2212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-241MUCINEX FAST-MAX DAY COLD AND FLU AND MUCINEX NIGHTSHIFT NIGHT SEVERE COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 6 package rows20241225_dbdafbb4-f3c9-4042-b867-db4d06dc3d61.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 41 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HCLHyVee Inc75b19163-db1c-42fc-8bbb-364be16b9b2f2026-03-30WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Inca9f23c63-eeda-4de9-aec6-fe482f469e982026-03-27WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17b8f17-95f6-37e4-e053-2995a90a411a2026-03-26WarningsExact identifier
application number: M012
Ultra concentrated Daytime/ Nighttime Severe SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGELCVS PHARMACY, INC24cedaec-06a6-8fde-e063-6394a90a3d7a2026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079537-1c06-1373-e063-6394a90a37d22026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2fa8c-071f-50ab-e063-6394a90a4a4a2026-03-26WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
application number: M012
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
application number: M012
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
application number: M012
childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inc686f43ea-4296-4eee-b762-9a9e683443402026-03-26WarningsExact identifier
application number: M012
Tussin DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59d3a486-97c2-4e60-90e2-1b5bfa7638c72026-03-26WarningsExact identifier
application number: M012
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
application number: M012
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
application number: M012
Walgreens Lavender Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a1a00-852d-2756-e063-6394a90a5e292026-03-25WarningsExact identifier
application number: M012
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company2d56ddcd-3cc8-51eb-e063-6394a90ae7452026-03-25WarningsExact 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) } PackGPCKdbdafbb4-f3c9-4042-b867-db4d06dc3d614
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) PackPSNdbdafbb4-f3c9-4042-b867-db4d06dc3d614
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNdbdafbb4-f3c9-4042-b867-db4d06dc3d614
2549037acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral TabletPSNdbdafbb4-f3c9-4042-b867-db4d06dc3d614
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDdbdafbb4-f3c9-4042-b867-db4d06dc3d614
2549037acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCDdbdafbb4-f3c9-4042-b867-db4d06dc3d614
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) PackSYdbdafbb4-f3c9-4042-b867-db4d06dc3d614
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYdbdafbb4-f3c9-4042-b867-db4d06dc3d614
2549037APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral TabletSYdbdafbb4-f3c9-4042-b867-db4d06dc3d614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-241-10728540241101 KIT in 1 CARTON (72854-241-10) / 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
72854-241-20728540241202 KIT in 1 CARTON (72854-241-20) / 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
72854-241-40728540241404 KIT in 1 CARTON (72854-241-40) / 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