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NDC 00135-0558-01 BIOTENE 1.5 mg/g Details
BIOTENE 1.5 mg/g
BIOTENE is a ORAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is SODIUM FLUORIDE.
MedlinePlus Drug Summary
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00135-0558-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 00135-0558 |
|---|---|
| Product ID | 0135-0558_0a3dc8fe-4218-85fa-e063-6294a90ad359 |
| 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 | BIOTENE |
| Proprietary Name Suffix | Gentle Mint |
| Non-Proprietary Name | sodium fluoride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE |
| Route | ORAL |
| Active Ingredient Strength | 1.5 |
| Active Ingredient Units | mg/g |
| Substance Name | SODIUM FLUORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M022 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00135-0558-01 (00135055801)
| NDC Package Code | 0135-0558-01 |
|---|---|
| Billing NDC | 00135055801 |
| Package | 1 TUBE in 1 CARTON (0135-0558-01) / 121.9 g in 1 TUBE |
| Marketing Start Date | 2013-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |