Over-the-counter drug · OTC MONOGRAPH DRUG
Family Care Earwax Removal (Carbamide peroxide) NDC 65923-639
Carbamide peroxide .065 mg/mL · Liquid · Auricular (Otic) · United Exchange Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65923-639-15 | 6592306391565923063915 | 1 BOTTLE, DROPPER in 1 CARTON (65923-639-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Oct 22, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Family Care Earwax Removal
- Generic name (nonproprietary)
- carbamide peroxide
- Active ingredients
- Carbamide peroxide — .065 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- United Exchange Corp.NDC labeler code 65923
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 65923-639_41c7b5be-d04d-cad3-e063-6294a90ae421SPL ID 41c7b5be-d04d-cad3-e063-6294a90ae421SPL set ID 958741f5-47c1-339c-e053-2a95a90a3f5fRxCUI 702050UNII 31PZ2VAU81UPC 0780707006399
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
N465923063915followed by a unit qualifier and the quantityPackage 65923-0639-15. 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)
Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in ear use twice daily for up to four days if needed, or as directed by a doctor any way remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe children under 12 years: consult a doctor
Excerpt only. Read the full label for complete information.
About NDC 65923-639
- What is NDC 65923-639?
- 65923-639 is the product NDC for Family Care Earwax Removal (carbamide peroxide), Carbamide peroxide .065 mg/mL liquid, listed with the FDA by United Exchange Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Family Care Earwax Removal (Carbamide Peroxide).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- United Exchange Corp., NDC labeler code 65923. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Family Care Earwax Removal?
- 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 |
|---|---|---|---|---|
| Alcohol Wipeswipe em alcohol wipes | Alcohol 75 mL/100mL | ClothTopical | Shaoxing Elite Bio-Tech Co., Ltd. | 81079-003 |
| Ear Wax Removal Dropscarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Sheffield Pharmaceuticals LLC | 11527-143 |
| Germa Manteca Ubre Plus (TIN)methyl salicylate 10% | Methyl salicylate 100 mg/mL | OintmentTopical | Germa Products, LLC | 73635-5805 |
| 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 |
| LEADER Ear Drops for Swimmers | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Cardinal Health, 110 dba Leader | 70000-0478 |
| 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 |
| 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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