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NDC 00135-0580-01 Sensodyne Pronamel 50; 1.15 mg/g; mg/g Details
Sensodyne Pronamel 50; 1.15 mg/g; mg/g
Sensodyne Pronamel is a DENTAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is POTASSIUM NITRATE; SODIUM FLUORIDE.
Product Information
| NDC | 00135-0580 |
|---|---|
| Product ID | 0135-0580_61a8fb28-ca4d-4fe5-925a-b6689c0350d2 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Sensodyne Pronamel |
| Proprietary Name Suffix | Gentle Whitening Advanced |
| Non-Proprietary Name | potassium nitrate and sodium fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE |
| Route | DENTAL |
| Active Ingredient Strength | 50; 1.15 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | POTASSIUM NITRATE; SODIUM FLUORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00135-0580-01 (00135058001)
| NDC Package Code | 0135-0580-01 |
|---|---|
| Billing NDC | 00135058001 |
| Package | 1 TUBE in 1 CARTON (0135-0580-01) / 184 g in 1 TUBE |
| Marketing Start Date | 2021-03-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |