Over-the-counter drug · OTC MONOGRAPH DRUG
LEADER Ear Drops for Swimmers NDC 70000-0478
Isopropyl alcohol 950 mg/mL · Liquid · Auricular (Otic) · Cardinal Health, 110 dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0478-1 | 7000004780170000047801 | 30 mL in 1 CONTAINER (70000-0478-1)Marketed from Apr 24, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- LEADER Ear Drops for Swimmers
- Generic name (nonproprietary)
- leader ear drops for swimmers
- Active ingredients
- Isopropyl alcohol — 950 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- Cardinal Health, 110 dba LeaderNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0478_0d19b149-c1b1-5180-e063-6394a90ad905SPL ID 0d19b149-c1b1-5180-e063-6394a90ad905SPL set ID 874857eb-2a9d-6ef7-e053-2995a90af156RxCUI 631799UNII ND2M416302
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N470000047801followed by a unit qualifier and the quantityPackage 70000-0478-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Dries water in the ears
Excerpt only. Read the full label for complete information.
About NDC 70000-0478
- What is NDC 70000-0478?
- 70000-0478 is the product NDC for LEADER Ear Drops for Swimmers, Isopropyl alcohol 950 mg/mL liquid, listed with the FDA by Cardinal Health, 110 dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- LEADER Ear Drops for Swimmers.
- What is the active ingredient?
- Isopropyl alcohol.
- Who is the labeler?
- Cardinal Health, 110 dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for LEADER Ear Drops for Swimmers?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 014
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
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| Germa Ubre Mastitismethyl salicylate 2% | Methyl salicylate 20 mg/mL | OintmentTopical | Germa Products, LLC | 73635-5807 |
| Meijer Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Meijer Distribution Inc | 41250-282 |
| GenRx Anti-Bacterial Gelalcohol | Alcohol 62 mL/100mL | LiquidTopical | PureTek Corporation | 59088-299 |
| Rite Aid Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Rite Aid | 11822-6117 |
| TopCare Swimmers Ear Dropsisopropyl alcohol | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | TOPCO ASSOCIATES | 36800-064 |
| Hand Sanitizing with Lavender Oilalcohol | Alcohol 62 mL/100mL | GelTopical | PureTek Corporation | 59088-413 |
| Family Care Earwax Removalcarbamide peroxide | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | United Exchange Corp. | 65923-639 |
| CaseysDishwashingSoapdishwashing detergent juniper forest | Chloroxylenol .2 g/100g | LiquidCutaneous, Topical | KYNC DESIGN LLC | 76557-050 |
| CaseysLavendercaseys hand soap lavender scent | Benzalkonium chloride .13 g/100g | LiquidTopical | KYNC Design LLC | 76557-051 |
| Harris Teeter Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Harris Teeter LLC | 69256-117 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
| Good Neighbor Pharmacy Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Proficient Rx LP | 71205-260 |
| DISCOUNT drug mart FOOD FAIR earwax removal kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | SolutionTopical | Discount Drug Mart | 53943-835 |
| Quality Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Chain Drug Marketing Association, Inc. | 63868-027 |
| blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4% | Menthol 40 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-286 |
| Quality Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Chain Drug Marketing Association, Inc. | 63868-026 |
| Hand Sanitizeralcohol | Alcohol 75 mL/100mL | SolutionTopical | Charlotte Products Ltd. | 64646-420 |
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