FDA.reportPublic FDA data

Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack

Product NDC
63824-944
11-digit product format
638240944
Labeler code
63824
Product ID
63824-944_5219f6db-4b48-8a9c-e063-6394a90afcae
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenylhydramine Hydrochloride, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Guaifenesin
Dosage form
KIT
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-25
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 Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack
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
1043543Internal RxNorm lookup
1375932Internal RxNorm lookup
2637728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7ab5201-8550-4bf4-957c-c8f049aeaa4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-944-34Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack1 in 1 CARTONKIT14
63824-949-01Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack1 in 1 CARTONSUSPENSION100 mg in 5mL4
63824-949-01Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack118 mL in 1 BOTTLESUSPENSION236 mL100 mg in 5mL4
63824-950-21Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack1 in 1 CARTONSOLUTION5 mg in 10mL4
63824-950-21Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 10mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-944MUCINEX CHILDRENS DAY TIME MULTI-SYMPTOM COLD AND MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD TRIPLE PACK (ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) KIT [RB HEALTH (US) LLC]3Current NDC, Legacy NDC, 5 package rows20241222_c7ab5201-8550-4bf4-957c-c8f049aeaa4a.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 130 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Daytime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Companye428dd83-c538-2a92-e053-2a95a90a0e162024-12-13WarningsExact identifier
application number: M012
Kroger Nighttime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
application number: M012
Foster and Thrive Childrens Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC7eaba464-5cdb-4bd4-b272-38fa108658d52024-12-13WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe OriginalOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC1d089074-3969-ce6e-e063-6294a90aa70c2024-12-12WarningsExact identifier
application number: M012
RIGHT REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Incb4fc014c-7c5f-46a4-bf13-57103b6fa0182024-12-11WarningsExact identifier
application number: M012
Diphenhydramine Hydrochloride 25mgDIPHENHYDRAMINE HYDROCHLORIDE 25MGStrive Pharmaceuticals Incb440eb2e-4de9-2b65-e053-2995a90abda82024-12-11WarningsExact identifier
application number: M012
Meijer Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.6933ca9d-a32d-d856-e053-2a91aa0a408e2024-12-10WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.826b5c0d-7a75-bbf0-e053-2a91aa0aebd62024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.09141018-37ba-4c93-9051-1ed129c448c12024-12-10WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola USA Inc.6ac9d95b-f6b9-4515-b126-697f8f8396122024-12-10WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola USA Inc.989d1529-2875-47bf-81df-65494d62be7a2024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.82813342-2be2-4731-ae90-dbd5eed667a92024-12-10WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.b640a5d2-a7fe-486d-a65f-e7c993f950d62024-12-10WarningsExact identifier
application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat DropsMENTHOLRicola USA Inc.c3f3c062-55e5-43c1-a016-ee47a7b388a52024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola USA Inc.ee4733b5-6e5a-438a-97da-110f3ef6c8092024-12-10WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola USA Inc.f62fcc38-2d43-40b3-841f-c8eea9ebd1e12024-12-10WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.8a6db093-7e52-443f-8dd6-94867606fef82024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola USA Inc.5885343e-4a6e-44f7-87a4-d525991561972024-12-10WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola USA Inc.0baf383c-886d-47ca-8a6d-221298c794462024-12-10WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEBest Choice (Valu Merchandisers Company)539b8972-2a46-468e-ad27-6672d746feb72024-12-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637728{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCKc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
26377281 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) PackPSNc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
26377281 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYc7ab5201-8550-4bf4-957c-c8f049aeaa4a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-944-34638240944341 KIT in 1 CARTON (63824-944-34) * 1 BOTTLE in 1 CARTON (63824-949-01) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (63824-950-21) / 118 mL in 1 BOTTLE1 kit2022-05-250000-00-00NoNoCurrent
63824-949-01638240949011 in 1 CARTONHistorical
63824-950-21638240950211 in 1 CARTONHistorical