childrens cough dm

Product NDC
0363-0899
11-digit product format
003630899
Labeler code
0363
Product ID
0363-0899_1ac3e561-8ddc-4922-81eb-0e7c8c7f2100
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-06-12
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
childrens cough dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0899-21childrens cough dm1 in 1 CARTONSUSPENSION19
0363-0899-21childrens cough dm89 mL in 1 BOTTLESUSPENSION899
0363-0899-28childrens cough dm1 in 1 CARTONSUSPENSION19
0363-0899-28childrens cough dm148 mL in 1 BOTTLESUSPENSION1489

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0899-21ML - Milliliter0363-0899043a14d1-74df-47d1-96a3-301b658ea67e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554CHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0899CHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]8Current NDC, Legacy NDC, 4 package rows20230906_317ab8e0-c329-4d4e-9fd0-4bff4e1504cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN317ab8e0-c329-4d4e-9fd0-4bff4e1504cd9
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD317ab8e0-c329-4d4e-9fd0-4bff4e1504cd9
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY317ab8e0-c329-4d4e-9fd0-4bff4e1504cd9
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY317ab8e0-c329-4d4e-9fd0-4bff4e1504cd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0899-21003630899211 BOTTLE in 1 CARTON (0363-0899-21) / 89 mL in 1 BOTTLE1 bottle2015-06-120000-00-00NoNoCurrent
0363-0899-28003630899281 BOTTLE in 1 CARTON (0363-0899-28) > 148 mL in 1 BOTTLE1 bottle2016-06-240000-00-00NoNoCurrent