FDA.reportPublic FDA data

leader childrens cough dm

Product NDC
70000-0195
11-digit product format
700000195
Labeler code
70000
Product ID
70000-0195_780efed5-fb7e-4bde-baa4-37807cd96914
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA091135
Marketing category
ANDA
Marketing start
2016-11-15
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
leader 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
70000-0195-1leader childrens cough dm1 in 1 CARTONSUSPENSION14
70000-0195-1leader childrens cough dm89 mL in 1 BOTTLESUSPENSION894

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0195-1ML - Milliliter70000-0195b41dffbb-5571-4706-a3bb-3b72e372be8712017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0195LEADER CHILDRENS COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20210618_3a468feb-da54-4a2c-bfce-bfe99f77efc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN3a468feb-da54-4a2c-bfce-bfe99f77efc34
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD3a468feb-da54-4a2c-bfce-bfe99f77efc34
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY3a468feb-da54-4a2c-bfce-bfe99f77efc34
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY3a468feb-da54-4a2c-bfce-bfe99f77efc34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0195-1700000195011 BOTTLE in 1 CARTON (70000-0195-1) / 89 mL in 1 BOTTLE1 bottle2016-11-150000-00-00NoNoCurrent