biotene

Product NDC
0135-0577
11-digit product format
001350577
Labeler code
0135
Product ID
0135-0577_c26f08a5-fa67-417e-8499-015edb65f7f8
Type
HUMAN OTC DRUG
Nonproprietary name
sodium monofluorophosphate
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0135-0577-01367a005e9d99…383a685ebd0f…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0135-0577-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0135-0577-01e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
biotene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a47a6502-efb2-4072-9562-cbe293531c2bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-11-05Drug Facts
2024-07-30Drug Facts
2024-01-30Drug Facts
2022-01-07Drug Facts
2020-09-27Drug Facts
2020-09-25Drug Facts
2020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0577-01biotene1 in 1 CARTONPASTE19
0135-0577-01biotene121.9 g in 1 TUBEPASTE121.99

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
CALCIUM LACTATEINACTIVE INGREDIENT2URQ2N32W3BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
CALCIUM PYROPHOSPHATEINACTIVE INGREDIENTX69NU20D19BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
CETETH-20INACTIVE INGREDIENTI835H2IHHXBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
DEXTRANASE PENICILLIUMINACTIVE INGREDIENTN2161X1O5OBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
GLUCOSE OXIDASEINACTIVE INGREDIENT0T8392U5N1BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
LACTOPEROXIDASE BOVINEINACTIVE INGREDIENT01UIN5OC49BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
LYSOZYME, CHICKEN EGG WHITEINACTIVE INGREDIENT1ZML031Y3CBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
MICAINACTIVE INGREDIENTV8A1AW0880BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
MUTANASE SCHIZOSACCHAROMYCES POMBEINACTIVE INGREDIENT7SOH7SS2HEBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
POTASSIUM THIOCYANATEINACTIVE INGREDIENTTM7213864ABIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
SODIUM COPPER CHLOROPHYLLININACTIVE INGREDIENT1D276TYV9OBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
SORBITOLINACTIVE INGREDIENT506T60A25RBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
TALACTOFERRIN ALFAINACTIVE INGREDIENT7A055A9QRRBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
WATERINACTIVE INGREDIENT059QF0KO0RBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE FRESH MINT ORIGINAL (SODIUM MONOFLUOROPHOSPHATE) PASTE BIOTENE GENTLE MINT (SODIUM MONOFLUOROPHOSPHATE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0577BIOTENE (SODIUM MONOFLUOROPHOSPHATE) PASTE [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 2 package rows20241107_a47a6502-efb2-4072-9562-cbe293531c2b.zip

openFDA label cross-check#

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.

Matched openFDA labels page 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC5965eb2a-1261-5258-e063-6294a90a7c2d2026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNa47a6502-efb2-4072-9562-cbe293531c2b9
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa47a6502-efb2-4072-9562-cbe293531c2b9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa47a6502-efb2-4072-9562-cbe293531c2b9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa47a6502-efb2-4072-9562-cbe293531c2b9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa47a6502-efb2-4072-9562-cbe293531c2b9
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa47a6502-efb2-4072-9562-cbe293531c2b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0577-01001350577011 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE1 tube2016-09-010000-00-00NoNoCurrent