warnings
Warnings
Leader Cough DM
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Leader Cough DM
- Generic name
- DEXTROMETHORPHAN POLISTIREX
- Manufacturer
- Cardinal Health 110, LLC. dba Leader
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a07b70d0-3842-4ea6-abb4-95b4638d5e55
- SPL ID
- c2af792f-30a1-4f16-8b10-1822d23df4ee
- Version
- 5
- Effective date
- 2026-04-08
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:47:20
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 091135 | derived:openfda.application_number |
| application number | ANDA091135 | openfda.application_number | |
| brand name | Leader Cough DM | openfda.brand_name | |
| generic name | DEXTROMETHORPHAN POLISTIREX | openfda.generic_name | |
| manufacturer name | Cardinal Health 110, LLC. dba Leader | openfda.manufacturer_name | |
| ndc | package | 70000-0302-2 | openfda.package_ndc |
| ndc | package | 70000-0302-1 | openfda.package_ndc |
| ndc | product | 70000-0302 | openfda.product_ndc |
| ndc11 | package | 70000030201 | derived:openfda.package_ndc |
| ndc11 | package | 70000030202 | derived:openfda.package_ndc |
| rxcui | 1373045 | openfda.rxcui | |
| spl id | c2af792f-30a1-4f16-8b10-1822d23df4ee | id | |
| spl set id | a07b70d0-3842-4ea6-abb4-95b4638d5e55 | set_id | |
| unii | 9D2RTI9KYH | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.