FDA.reportPublic FDA data

Mucinex Childrens Cough and Congestion

Product NDC
63824-947
11-digit product format
638240947
Labeler code
63824
Product ID
63824-947_5219f3a4-ccd0-d4ae-e063-6294a90a26d2
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct63824-947IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63824-94763824-947-11IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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 Cough and Congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9e5a8d7-814c-4ab1-bb05-e4cb9155978eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-947-112020-06-16C16284748780-19d75b9d0-d516-f424-e053-dadaa90a57ceMucinex® Children's Cough & Congestion
63824-947-112020-01-31C16284748780-19d75b9d0-d516-f424-e053-dadaa90a57ceMucinex® Children's Cough & Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-947-11Mucinex Childrens Cough and Congestion1 in 1 CARTONSUSPENSION17
63824-947-11Mucinex Childrens Cough and Congestion201 mL in 1 BOTTLESUSPENSION2017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-947-11ML - Milliliter63824-947580f6bd1-0a5f-4e6f-b8c6-cd01cfa4e66b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-947MUCINEX CHILDRENS COUGH AND CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [RB HEALTH (US) LLC]6Current NDC, Legacy NDC, 2 package rows20241222_d9e5a8d7-814c-4ab1-bb05-e4cb9155978e.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 47 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012
NIGHTTIME CHERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.36924420-f514-4225-e063-6294a90a330c2026-03-03WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP4584d701-5a4e-e54e-e063-6394a90a38d62026-03-03WarningsExact identifier
application number: M012
foster and thrive nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESportpharm LLC7bdfd2ef-bb99-41f5-97ae-3a02c994bddd2026-03-03WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLCd27b5976-8cc0-4d99-96f6-9069b786affd2026-03-03WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINA-S Medication Solutions7f703c9c-2256-4524-9d31-c51919399d262026-03-03WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)f49f1e9a-07ac-443e-9df8-3281d5f35e782026-03-03WarningsExact identifier
application number: M012
berkley and jensen nasalOXYMETAZOLINE HYDROCHLORIDEBJWC77cbe75d-4ed9-4a8b-91dc-1cc28af255082026-03-02WarningsExact identifier
application number: M012
childrens cold and cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWalgreen Company6c7c950d-ed48-4428-9e9e-73684cabc6992026-02-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.1f737b76-14b5-618a-e063-6294a90a19c22026-02-27WarningsExact identifier
application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEFDOXYLAMINE SUCCINATEWALGREENS CO.a3c7df98-4611-4b61-9c03-5e687364bf742026-02-27WarningsExact identifier
application number: M012
MEIJER Childrens Allergy Relief ChewsDIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC3368e081-a3b2-4c03-8bd1-05cc6af0391d2026-02-27WarningsExact identifier
application number: M012
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
application number: M012
Tussin DM Cough and ChestDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC402969c9-945c-44b7-b018-b62f427ce5712026-02-26WarningsExact identifier
application number: M012
nasal originalOXYMETAZOLINE HYDROCHLORIDEHyVee Incd997f264-1b4a-4cca-a282-bd9645d55bfd2026-02-26WarningsExact identifier
application number: M012
Multi-Symptom Cold and Fever ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY2a569e47-3f17-4fc7-83d6-a3dddfd4987e2026-02-25WarningsExact identifier
application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED184059b7-9238-480e-be4a-ed105f13c19d2026-02-25WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-947-11638240947111 BOTTLE in 1 CARTON (63824-947-11) / 201 mL in 1 BOTTLE1 bottle2018-03-300000-00-00NoNoCurrent