FDA.reportPublic FDA data

BIOTENE

Product NDC
0135-0557
11-digit product format
001350557
Labeler code
0135
Product ID
0135-0557_95462fd1-5eb4-46ff-bf63-a5e610337bc6
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-15
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BIOTENE
Brand name suffix
Fresh Mint Original
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783, 1044547

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0557-012024-11-05C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-022024-11-05C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-012024-07-30C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-022024-07-30C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-012024-01-30C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-022024-01-30C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-012022-08-24C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-022022-08-24C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-012022-07-29C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0557-022022-07-29C16284748780-1e4f33bdf-9ec6-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0557-01BIOTENEFresh Mint Original1 in 1 CARTONPASTE110
0135-0557-01BIOTENEFresh Mint Original121.9 g in 1 TUBEPASTE121.910
0135-0557-02BIOTENEFresh Mint Original19.8 g in 1 TUBEPASTE19.810
0135-0557-02BIOTENEFresh Mint Original1 in 1 CARTONPASTE110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0557-01GM - Gram0135-0557b4e1c4d8-3b80-4e80-b115-97c5a7ab00ef12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SORBITOLINACTIVE INGREDIENT506T60A25RBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
WATERINACTIVE INGREDIENT059QF0KO0RBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE BIOTENE PBF (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0557BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 4 package rows20241107_1101c17f-c848-4cd5-a7cd-679b59dbe1bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
1044547sodium fluoride 0.25 % ToothpastePSN1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY1101c17f-c848-4cd5-a7cd-679b59dbe1bf10
1044547sodium fluoride 0.25 % ToothpasteSY1101c17f-c848-4cd5-a7cd-679b59dbe1bf10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0557-01001350557011 TUBE in 1 CARTON (0135-0557-01) / 121.9 g in 1 TUBE1 tube2013-07-150000-00-00NoNoCurrent
0135-0557-02001350557021 TUBE in 1 CARTON (0135-0557-02) / 19.8 g in 1 TUBE1 tube2013-07-150000-00-00NoNoCurrent