Adults and children over 12 years • apply toothpaste onto a soft bristle toothbrush • brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.
store below 25°C (77F°)
www.biotene.comSodium Fluoride (0.15% w/v fluoride ion)
Anticavity
aids in the prevention of dental cavities
If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.
If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients.
Adults and children over 12 years
Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.
store below 25°C (77F°)
Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide
Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1
call toll-free 1-800-922-5856 weekdays
NDC 0135-0557-01
biotene®
FLUORIDE TOOTHPASTE
GENTLE FORMULA
SPECIALLY FORMULATED TO NOT IRRITATE
FRESH MINT ORIGINAL
NET WT 4.3 OZ (121.9g)
FROM THE MAKERS OF BIOTENE
#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS
HELPS MAINTAIN ORAL ENVIRONMENT
Also look for other biotene® products including biotene® Oral Rinses, biotene® oralbalance Gel, and biotene® Mouth Spray.
ALWAYS FOLLOW THE LABEL
This product contains no Sodium Lauryl Sulfate (SLS)
Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102875XC
NDC 0135-0558-01
biotene®
FLUORIDE TOOTHPASTE
GENTLE FORMULA
SPECIALLY FORMULATED TO NOT IRRITATE
GENTLE MINT
NET WT 4.3 OZ (121.9g)
FROM THE MAKERS OF BIOTENE
#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS
HELPS MAINTAIN ORAL ENVIRONMENT
Also look for other biotene® products including biotene® Oral Rinses, biotene® oralbalance Gel, and biotene® Mouth Spray.
ALWAYS FOLLOW THE LABEL
This product contains no Sodium Lauryl Sulfate (SLS)
Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102874XC
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 10 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | PSN | 10 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 10 |
| 1044547 | sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 10 |
| 1044547 | sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste | SY | 10 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | SY | 10 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0557-01 | BIOTENEFresh Mint Original | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0557-01 | BIOTENEFresh Mint Original | 121.9 g in 1 TUBE | PASTE | 121.9 | 10 | |
| 0135-0557-02 | BIOTENEFresh Mint Original | 19.8 g in 1 TUBE | PASTE | 19.8 | 10 | |
| 0135-0557-02 | BIOTENEFresh Mint Original | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0558-01 | BIOTENEGentle Mint | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0558-01 | BIOTENEGentle Mint | 121.9 g in 1 TUBE | PASTE | 121.9 | 10 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0557 | BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241107_1101c17f-c848-4cd5-a7cd-679b59dbe1bf.zip |
| 0135-0558 | BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241107_1101c17f-c848-4cd5-a7cd-679b59dbe1bf.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0557-01 | GM - Gram | 0135-0557 | b4e1c4d8-3b80-4e80-b115-97c5a7ab00ef | 1 | 2015-07-20 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 5 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 5 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 5 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 5 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 5 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0135-0557 | 0135-0557-01, 0135-0557-02 |
| 0135-0558 | 0135-0558-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, DELAYED RELEASE / ORAL | 35 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SYRUP / ORAL | 740 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GRANULE, FOR SUSPENSION / ORAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CONCENTRATE / ORAL | 10 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, EXTENDED RELEASE / ORAL | 13 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, EXTENDED RELEASE / ORAL | 13 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GRANULE, FOR SUSPENSION / ORAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BIOTENE Fresh Mint Original | SODIUM FLUORIDE | Haleon US Holdings LLC | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 2024-11-05 | Warnings | 0135-0558-01 0135-0557-02 0135-0557-01 0135-0558 0135-0557 00135055701 00135055801 00135055702 95462fd1-5eb4-46ff-bf63-a5e610337bc6 1101c17f-c848-4cd5-a7cd-679b59dbe1bf |
Adverse event summaries are temporarily unavailable. Other product information remains available.