Over-the-counter drug · OTC MONOGRAPH DRUG
Earwax Removal Drops (Carbamide peroxide 6.5%) NDC 0395-9133
Carbamide peroxide .065 mg/mL · Liquid · Auricular (Otic) · Humco Holding Group, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0395-9133-45 | 0039591334500395913345 | 1 BOTTLE, DROPPER in 1 CARTON (0395-9133-45) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jun 4, 2019 | |
| 0395-9133-90 | 0039591339000395913390 | 1 CONTAINER in 1 CARTON (0395-9133-90) / 15 mL in 1 CONTAINERMarketed from Jun 4, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Earwax Removal Drops
- Generic name (nonproprietary)
- carbamide peroxide 6.5%
- Active ingredients
- Carbamide peroxide — .065 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- Humco Holding Group, IncNDC labeler code 0395
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 0395-9133_0c93a2f8-8199-15fb-e063-6394a90a5521SPL ID 0c93a2f8-8199-15fb-e063-6394a90a5521SPL set ID a8c052d8-fb9c-09f2-e053-2a95a90a37afUNII 31PZ2VAU81UPC 0096295137040
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
N400395913345followed by a unit qualifier and the quantityPackage 00395-9133-45. 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)
For occasional use as an aid to soften, loosen and remove excessive earwax.
Excerpt only. Read the full label for complete information.
About NDC 0395-9133
- What is NDC 0395-9133?
- 0395-9133 is the product NDC for Earwax Removal Drops (carbamide peroxide 6.5%), Carbamide peroxide .065 mg/mL liquid, listed with the FDA by Humco Holding Group, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Earwax Removal Drops (Carbamide Peroxide 6.5%).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Humco Holding Group, Inc, NDC labeler code 0395. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Earwax Removal Drops?
- 2 other product NDCs are listed under this name. See all Earwax Removal Drops NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Earwax Removal Drops products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Randob Labs, Ltd. | 52412-600 | 52412-0600-05 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Pharma Nobis, LLC | 82645-910 | 82645-0910-4582645-0910-90 |
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 |
| 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 |
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