FDA.reportPublic FDA data

Leader Cough DM

Product NDC
70000-0187
11-digit product format
700000187
Labeler code
70000
Product ID
70000-0187_a05d5a66-fab7-47e8-b265-d2e19e9ffb13
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
2016-12-05
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 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
70000-0187-1Leader Cough DM89 mL in 1 BOTTLESUSPENSION895
70000-0187-1Leader Cough DM1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0187-1ML - Milliliter70000-0187a48c4e74-fc8a-4193-8afe-3eaac1411bca12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0187LEADER COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20210618_4c99b5e3-cd79-4c54-ae37-3673c836e668.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN4c99b5e3-cd79-4c54-ae37-3673c836e6685
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD4c99b5e3-cd79-4c54-ae37-3673c836e6685
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY4c99b5e3-cd79-4c54-ae37-3673c836e6685
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY4c99b5e3-cd79-4c54-ae37-3673c836e6685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0187-1700000187011 BOTTLE in 1 CARTON (70000-0187-1) / 89 mL in 1 BOTTLE1 bottle2016-12-050000-00-00NoNoCurrent