FDA.reportPublic FDA data

Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime

Product NDC
63824-959
11-digit product format
638240959
Labeler code
63824
Product ID
63824-959_5219fc2d-5851-95df-e063-6394a90ad19d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
325; 10; 5; 1.25 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL
TRIPROLIDINE HYDROCHLORIDE1.25 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2173662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84e7be8f-2785-45ef-9c44-de05394fcd99Available on FDA.report

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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-959-64Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime1 in 1 CARTONSOLUTION14
63824-959-64Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime118 mL in 1 BOTTLESOLUTION1184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-959-64ML - Milliliter63824-9590ff88bcd-e3c9-44ff-872c-eca9997da78e12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-959MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 2 package rows20241228_84e7be8f-2785-45ef-9c44-de05394fcd99.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 93 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWAL-MART STORES,INC.68a68574-0fcb-4569-be57-d9aee5f62bea2025-10-28WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores,Inc.,635009a1-6154-4c62-a4be-d4f32c2cef8d2025-10-28WarningsExact identifier
application number: M012
Publix Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCcf49a06d-f095-48bf-bcd2-a410066ff9af2025-10-28WarningsExact identifier
application number: M012
PublixOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC283e42b9-173c-4deb-9377-ff649efc177f2025-10-28WarningsExact identifier
application number: M012
Publix Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCeae83b75-9d5a-4100-9304-629e54ef77522025-10-28WarningsExact identifier
application number: M012
PublixPHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCf10e120d-f0b7-4c51-b29b-e8cdbb1456f32025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0f8e9e-0503-522b-e053-2a91aa0aca352025-10-28WarningsExact identifier
application number: M012
Family Care Nasal ReliefOXYMETAZOLINE HYDROCHLORIDEUnited Exchange Corp6d0eef2f-f546-d769-e053-2991aa0a8fe42025-10-28WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Congestion AdultDEXTROMETHORPHAN HBR, GUAIFENESINP & L Development, LLC4af67ba7-8892-442c-b9fb-80aba9140e052025-10-28WarningsExact identifier
application number: M012
No Drip Nasal Mist Nasal Decongestant Severe CongestionOXYMETAZOLINE HYDROCHLORIDEWal-Mart Stores,Inc.,994fa270-65bb-4097-b88a-d5ce3c0e1c792025-10-27WarningsExact identifier
application number: M012
Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWAL-MART STORES INC.3652ee94-b762-4100-a305-5acbec5f795a2025-10-27WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLWal-Mart Stores,Inc.,2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc2025-10-27WarningsExact identifier
application number: M012
Allergies MY CHILD NEEDS HELP WITHDIPHENHYDRAMINE HCLUnconditional Love5ad293e9-0a4b-4923-8a91-f014507268282025-10-27WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC4a9fd615-b7d3-452c-ac40-d9189124faaa2025-10-24WarningsExact identifier
application number: M012
allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Inc622b12fa-455c-4432-a9a2-698a929bbd682025-10-24WarningsExact identifier
application number: M012
Dristan 12 hrOXYMETAZOLINE HYDROCHLORIDEFoundation Consumer Brands522876fe-a412-4ca8-bfad-a313e3cbc1af2025-10-24WarningsExact identifier
application number: M012
Dimetapp Multi-Symptom Cold and FluACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFoundation Consumer Healthcare178fe95b-e1ed-43b2-e063-6294a90a7a782025-10-24WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporationc831d3d9-b910-40e6-bfdf-defe6850614d2025-10-24WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation7d2f3292-bb73-41dc-9729-edb83670be1b2025-10-24WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLR.L. ALBERT & SON, INCb174e57c-4e4f-4842-b8f2-f1b067764a682025-10-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173662acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN84e7be8f-2785-45ef-9c44-de05394fcd994
2173662acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD84e7be8f-2785-45ef-9c44-de05394fcd994
2173662acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral SolutionSY84e7be8f-2785-45ef-9c44-de05394fcd994
2173662acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY84e7be8f-2785-45ef-9c44-de05394fcd994
2173662APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY84e7be8f-2785-45ef-9c44-de05394fcd994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-959-64638240959641 BOTTLE in 1 CARTON (63824-959-64) / 118 mL in 1 BOTTLE1 bottle2020-06-010000-00-00NoNoCurrent