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NDC 36800-0835-33 TopCare Earwax Removal Kit 65 mg/mL Details
TopCare Earwax Removal Kit 65 mg/mL
TopCare Earwax Removal Kit is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is CARBAMIDE PEROXIDE.
Product Information
| NDC | 36800-0835 |
|---|---|
| Product ID | 36800-835_0c7fdbaa-6425-7749-e063-6294a90a7a36 |
| Associated GPIs | 87400030002010 |
| GCN Sequence Number | 008120 |
| GCN Sequence Number Description | carbamide peroxide DROPS 6.5 % OTIC (EAR) |
| HIC3 | Q8R |
| HIC3 Description | EAR PREPARATIONS,EAR WAX REMOVERS |
| GCN | 34401 |
| HICL Sequence Number | 004272 |
| HICL Sequence Number Description | CARBAMIDE PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | TopCare Earwax Removal Kit |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | CARBAMIDE PEROXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | 65 |
| Active Ingredient Units | mg/mL |
| Substance Name | CARBAMIDE PEROXIDE |
| Labeler Name | TOPCO ASSOCIATES LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M014 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0835-33 (36800083533)
| NDC Package Code | 36800-835-33 |
|---|---|
| Billing NDC | 36800083533 |
| Package | 1 BOTTLE, DISPENSING in 1 CARTON (36800-835-33) / 15 mL in 1 BOTTLE, DISPENSING |
| Marketing Start Date | 2014-11-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |