FDA.reportPublic FDA data

Mucinex Childrens

Product NDC
63824-950
11-digit product format
638240950
Labeler code
63824
Product ID
63824-950_5219c31b-0922-97cf-e063-6294a90a42df
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63824-950-2186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63824-950-21bd6a592717d7…303034d00443…

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
Brand name suffix
Night Time Multi-Symptom Cold
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1375932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e048cd53-a3cd-484f-a972-4cb49791dba3Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-04-08Mucinex® Children's Night Time Multi-Symptom Cold
2022-01-28Mucinex® Children's Night Time Multi-Symptom Cold
2020-10-21Mucinex® Children's Night Time Multi-Symptom Cold
2020-09-27Mucinex® Children's Night Time Multi-Symptom Cold
2020-09-25Mucinex® Children's Night Time Multi-Symptom Cold
2020-07-22Mucinex® Children's Night Time Multi-Symptom Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-950-21Mucinex ChildrensNight Time Multi-Symptom Cold118 mL in 1 BOTTLESOLUTION1189
63824-950-21Mucinex ChildrensNight Time Multi-Symptom Cold1 in 1 CARTONSOLUTION19
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
63824-950MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]8Current NDC, Legacy NDC, 2 package rows20241222_e048cd53-a3cd-484f-a972-4cb49791dba3.zip
63824-950MUCINEX 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 NDC20241222_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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)047102c4-3d03-4b2d-961d-0ac75980147b2026-05-06WarningsExact identifier
application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Companyd25f2649-4f8a-4339-8443-faa0b98bdd702026-05-06WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEWinCo Foods, LLC27e911e1-6d22-4a50-8413-1809c8973cbd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51173330-d537-fb9c-e063-6394a90ae3422026-05-05WarningsExact identifier
application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc08e74a8d-8e8d-4cda-9adc-ea2ff40683532026-05-05WarningsExact identifier
application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companye42f9e0d-f990-4c33-af43-75acf5d776382026-05-05WarningsExact identifier
application number: M012
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsExact identifier
application number: M012
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
application number: M012
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
application number: M012
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLC098428ae-e87d-4c29-8f02-1590530da58e2026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNe048cd53-a3cd-484f-a972-4cb49791dba39
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDe048cd53-a3cd-484f-a972-4cb49791dba39
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYe048cd53-a3cd-484f-a972-4cb49791dba39
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYe048cd53-a3cd-484f-a972-4cb49791dba39
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYe048cd53-a3cd-484f-a972-4cb49791dba39
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYe048cd53-a3cd-484f-a972-4cb49791dba39
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYe048cd53-a3cd-484f-a972-4cb49791dba39
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) } PackGPCKe3aea6df-37a4-43c5-a192-a902cbff3f926
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) PackPSNe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSNe3aea6df-37a4-43c5-a192-a902cbff3f926
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDe3aea6df-37a4-43c5-a192-a902cbff3f926
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDe3aea6df-37a4-43c5-a192-a902cbff3f926
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) PackSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYe3aea6df-37a4-43c5-a192-a902cbff3f926
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
63824-950-21638240950211 BOTTLE in 1 CARTON (63824-950-21) / 118 mL in 1 BOTTLE1 bottle2018-05-010000-00-00NoNoCurrent