Over-the-counter drug · OTC MONOGRAPH DRUG
ear drops (Carbamide peroxide 6.5%) NDC 69452-377
Carbamide peroxide .065 mg/mL · Liquid · Auricular (Otic) · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-377-75 | 6945203777569452037775 | 1 BOTTLE, DROPPER in 1 CARTON (69452-377-75) / 15 mL in 1 BOTTLE, DROPPERMarketed from Sep 15, 2022 | |
| 69452-377-95 | 6945203779569452037795 | 2 BOTTLE, DROPPER in 1 CARTON (69452-377-95) / 15 mL in 1 BOTTLE, DROPPERMarketed from Sep 15, 2022 |
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)
- ear drops
- Generic name (nonproprietary)
- carbamide peroxide 6.5%
- Active ingredients
- Carbamide peroxide — .065 mg/mL
- Dosage form
- Liquid
- Route
- Auricular (Otic)
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 69452-377_507543ad-0cd9-75be-e063-6394a90aee95SPL ID 507543ad-0cd9-75be-e063-6394a90aee95SPL set ID e8bcf92c-ad32-49d5-e053-2995a90ae0c6RxCUI 702050UNII 31PZ2VAU81
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
N469452037775followed by a unit qualifier and the quantityPackage 69452-0377-75. 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)
Uses For occasional use as an aid to soften, loosen and remove excessive earwax
Excerpt only. Read the full label for complete information.
About NDC 69452-377
- What is NDC 69452-377?
- 69452-377 is the product NDC for ear drops (carbamide peroxide 6.5%), Carbamide peroxide .065 mg/mL liquid, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ear drops (Carbamide Peroxide 6.5%).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ear drops?
- 1 other product NDC are listed under this name. See all ear drops NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ear 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) |
|---|---|---|---|---|---|
| Ear Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | CVS Pharmacy | 69842-097 | 69842-0097-4569842-0097-90 |
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 |
|---|---|---|---|---|
| Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Oaktree Products Inc | 59256-836 |
| TopCare Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | Topco Associates LLC | 76162-836 |
| Equate Swimmers Instant Ear Dry | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | Walmart Stores, Inc | 49035-989 |
| Macks Dry n Clearear drying aid | Isopropyl alcohol 950 mg/mL | LiquidAuricular (Otic) | McKeon Products Inc | 66354-001 |
| Wax Away Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-005 |
| Wax Away Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-006 |
| ProRinse Earwax Removal Systemcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsAuricular (Otic) | McKeon Products Inc | 66354-007 |
| HylaTearseye drops | Hypromellose 2910 (4000 mpa.s) 3 mg/10mL | LiquidOphthalmic | Hyalogic LLC | 72094-001 |
| Dri-Ear | Isopropyl alcohol 950 mg/mL | Suspension/ dropsAuricular (Otic) | S.S.S. Company | 12258-153 |
| Ear Wash Refill Equatecarbamide peroxide | — | Kit | Walmart | 79903-403 |
| Debroxcarbamide peroxide | Carbamide peroxide 65 mg/mL | LiquidAuricular (Otic) | A-S Medication Solutions | 50090-4201 |
| ERO Ear Wax Removal Kitcarbamide peroxide 6.5% | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Randob Labs | 52412-175 |
| GoodSense Ear Wax Removal Kitcarbamide peroxide | Carbamide peroxide 6.5 g/100mL | LiquidTopical | Geiss, Destin & Dunn, Inc | 50804-117 |
| Foster and Thrive Earwax Removal Kit Ear wax dropscarbamide peroxide | — | Kit | Mckesson Corp. Via Strategic Sourcing Services | 70677-1153 |
| HANCHOBIT Lemon Turmeric Kojic Acid Brighteningglycerin | Lemon .02 g/100g; Turmeric .02 g/100g | SoapTopical | HANCHOYEANBIOTEC Co.,Ltd. | 85164-002 |
| Foster and Thrive Earwax Removal Dropscarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Mckesson Corp. Via Strategic Sourcing Services | 70677-1154 |
| Earwax Removal Dropscarbamide peroxide 6.5% | Carbamide peroxide .065 mg/mL | LiquidAuricular (Otic) | Randob Labs, Ltd. | 52412-600 |
| Auralytcarbamide peroxide | Carbamide peroxide 7.8 mg/12mL | LiquidTopical | Menper Distributors, Inc | 53145-311 |
| Major Earwax Removal Drops Earwax Removal Aidcarbamide peroxide | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | Major Pharmaceuticals | 0904-7478 |
| JAYSUING Silicone Scar Gelglycerin | Centella asiatica root .006 mg/30mg | GelTopical | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 85060-007 |
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