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.
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|---|---|---|---|---|
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| Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Oaktree Products Inc | 59256-836 |
| Audiologists Choice Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Oaktree Products Inc. | 59256-001 |
| Auralytcarbamide peroxide | Carbamide peroxide 7.8 mg/12mL | LiquidTopical | Menper Distributors, Inc | 53145-311 |
| Auro Driisopropyl alcohol | Isopropyl alcohol 95 mL/100mL | LiquidAuricular (Otic) | Insight Pharmaceuticals LLC | 63736-327 |
| Bacitracin | Bacitracin 500 [USP'U]/g | OintmentTopical | NuCare Pharmaceuticals,Inc. | 68071-5253 |
| Benzoyl Peroxide Acne Medicationbenzoyl peroxide | Benzoyl peroxide 50 mg/mL | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-2307 |
| Best Choice Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Valu Merchandisers Company | 63941-836 |
| Best Choice Earwax Removal Kitcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidTopical | Valu Merchandisers, Co. | 63941-835 |
| blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4% | Menthol 40 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-286 |
| blue goo NERVE EASE Pain RELIEF Topical Analgesiclidocaine hcl 4%, menthol 1% | Lidocaine 40 mg/mL; Menthol 10 mg/mL | LiquidTopical | Garcoa, Inc. | 67385-825 |
| Bodyographypro Anti-Bacterial Sanitizingethyl alcohol | Alcohol 60 mL/100mL | SprayTopical | Robanda International, Inc. | 53950-6010 |
| Caladrylferric oxide red, zinc oxide, and pramoxine hydrochloride | Ferric oxide red 1.36 mg/mL + 2 more ingredients | LotionTopical | Bausch Health US, LLC | 0187-5465 |
| Caladryl Clearpramoxine hydrochloride and zinc acetate | Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL | LotionTopical | Bausch Health US, LLC | 0187-5466 |
| Carbamide peroxide 6.5%earwax removal kit | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Allegiant Health | 69168-488 |
| CareOne Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Retail Business Services, LLC | 72476-838 |
| 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 |
| ClearCanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | NeilMed Pharmaceuticals, Inc. | 13709-230 |
| Clearcanal Ear Wax Softerner Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7426 |
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