FDA.reportPublic FDA data

DeCure

Product NDC
84132-100
11-digit product format
841320100
Labeler code
84132
Product ID
84132-100_cdcda1fe-a465-4aca-baba-c3e2114a9952
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Scope medical devices private limited
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-11
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
7.6 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
DeCure
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 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
590c4827-f036-45bd-af30-0a4853ca3447Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84132-100-10DeCure10 g in 1 TUBEPASTE, DENTIFRICE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84132-100DECURE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SCOPE MEDICAL DEVICES PRIVATE LIMITED]1Current NDC, 1 package rows20240628_590c4827-f036-45bd-af30-0a4853ca3447.zip
84132-100NORTHSIDE HOSPITAL GREY AMENITY KIT (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]1Current NDC20250426_a3cc89df-be1b-4d9a-8ba3-857885325422.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 70 % Topical GelPSN5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 70 % Topical GelPSNa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelPSN0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % ToothpastePSN0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % ToothpastePSNa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % ToothpastePSN86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % ToothpastePSN590c4827-f036-45bd-af30-0a4853ca34471
545626sodium monofluorophosphate 0.76 % ToothpastePSN5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 0.7 ML/ML Topical GelSCD86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 0.7 ML/ML Topical GelSCD5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 0.7 ML/ML Topical GelSCD0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethanol 0.7 ML/ML Topical GelSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD590c4827-f036-45bd-af30-0a4853ca34471
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 70 % Topical GelSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
581662ethanol 70 % Topical GelSY5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethanol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethyl alcohol 70 % Topical GelSY5d0e768f-086c-4b8c-b618-6dde70f302f91
581662ethyl alcohol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethyl alcohol 70 % Topical GelSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
581662ethyl alcohol 70 % Topical GelSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY590c4827-f036-45bd-af30-0a4853ca34471
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY590c4827-f036-45bd-af30-0a4853ca34471
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY590c4827-f036-45bd-af30-0a4853ca34471
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY86458169-92eb-45a5-b3cc-6eccd8caa1e81
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0868060e-d593-4cb2-b3d2-6c59d1ae5efc1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5d0e768f-086c-4b8c-b618-6dde70f302f91
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY590c4827-f036-45bd-af30-0a4853ca34471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84132-100-108413201001010 g in 1 TUBE (84132-100-10) 10 g2024-05-11NoNoCurrent