FDA.reportPublic FDA data

childrens multi symptom cold

Product NDC
0363-9839
Requested package NDC
0363-9839-26
11-digit product format
003639839
Labeler code
0363
Product ID
0363-9839_b8316be3-f158-49bb-8ca2-d29d1823ec4a
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-27
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage0363-98390363-9839-26DDiscontinued by firm2026-10-20

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-98390363-9839-26DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-98390363-9839-26DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9839-26ML - Milliliter0363-98399f297a85-3a65-4c96-a722-9ab7f54ba10812015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9839CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY]4Legacy NDC20241116_5900a96f-f0f7-4a24-834c-cf2b1b527753.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9839-26003639839261 BOTTLE in 1 CARTON (0363-9839-26) > 118 mL in 1 BOTTLE1 bottle2015-06-270000-00-00NoNoCurrent