Childrens Mucinex

Product NDC
63824-286
Requested package NDC
63824-286-64
11-digit product format
638240286
Labeler code
63824
Product ID
63824-286_24ec5cc3-2b8b-455e-b3ad-63717519166c
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
RB Health (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-13
Marketing end
2024-02-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5 mg/5mL; mg/5mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63824-28663824-286-64DDiscontinued by firm2026-10-15

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-286-642022-03-04C16284748780-19d75b9d0-5e42-f424-e053-dadaa90a57ceChildren's Mucinex® Cough
63824-286-642020-01-31C16284748780-19d75b9d0-5e42-f424-e053-dadaa90a57ceChildren's Mucinex® Cough

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-286-64ML - Milliliter63824-2866fb37eeb-032a-47b2-aba6-0117dd623d2812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
GuaifenesinACTIVE INGREDIENT495W7451VQCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
DextromethorphanACTIVE MOIETY7355X3ROTSCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
GuaifenesinACTIVE MOIETY495W7451VQCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
propyl gallateINACTIVE INGREDIENT8D4SNN7V92CHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS MUCINEX COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RECKITT BENCKISER LLC]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-286-64638240286641 BOTTLE in 1 CARTON (63824-286-64) > 118 mL in 1 BOTTLE1 bottle2012-07-132024-02-15NoNoCurrent