Over-the-counter drug · OTC MONOGRAPH DRUG
Ear Wax Removal Drops (Carbamide peroxide - 6.5%) NDC 11527-143
Carbamide peroxide 65 mg/mL · Solution/ drops · Topical · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-143-51 | 1152701435111527014351 | 1 BOTTLE, DROPPER in 1 CARTON (11527-143-51) / 15 mL in 1 BOTTLE, DROPPERMarketed from Feb 2, 2017 |
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 Wax Removal Drops
- Generic name (nonproprietary)
- carbamide peroxide - 6.5%
- Active ingredients
- Carbamide peroxide — 65 mg/mL
- Dosage form
- Solution/ drops
- Route
- Topical
- Labeler
- Sheffield Pharmaceuticals LLCNDC labeler code 11527
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 014
- Marketing start
- Listing expires
- Identifiers
- Product ID 11527-143_184c7110-33c6-4b58-bc79-451870131f3aSPL ID 184c7110-33c6-4b58-bc79-451870131f3aSPL set ID aad7e2cd-cb28-423c-a441-eabe6516d40fRxCUI 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411527014351followed by a unit qualifier and the quantityPackage 11527-0143-51. 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 ear wax.
Excerpt only. Read the full label for complete information.
About NDC 11527-143
- What is NDC 11527-143?
- 11527-143 is the product NDC for Ear Wax Removal Drops (carbamide peroxide - 6.5%), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ear Wax Removal Drops (Carbamide Peroxide - 6.5%).
- What is the active ingredient?
- Carbamide peroxide.
- Who is the labeler?
- Sheffield Pharmaceuticals LLC, NDC labeler code 11527. 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 Wax Removal Drops?
- 1 other product NDC are listed under this name. See all Ear Wax 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 Ear Wax 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) |
|---|---|---|---|---|---|
| Ear Wax Removal Dropscarbamide peroxide - 6.5% | Carbamide peroxide 65 mg/mL | Solution/ dropsTopical | GeriCare Pharmaceutical Corp | 57896-339 | 57896-0339-05 |
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 |
| 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 |
| Hand Sanitizeralcohol | Alcohol 75 mL/100mL | SolutionTopical | Charlotte Products Ltd. | 64646-420 |
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