FDA.reportPublic FDA data

Iris 60 Second APF

Product NDC
66975-053
11-digit product format
669750053
Labeler code
66975
Product ID
66975-053_d70c7b9f-7d80-51ac-e053-2995a90a4a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Benco Dental
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-12-14
Substance
SODIUM FLUORIDE
Active strength
5.6 g/454g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Iris 60 Second APF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5.6 g/454g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f5d420b-3348-4002-9a09-b05e8cbb35c9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-053-15Iris 60 Second APF454 g in 1 BOTTLE, PLASTICGEL4543

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7IRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
WATERINACTIVE INGREDIENT059QF0KO0RIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EIRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-053IRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]3Current NDC, Legacy NDC, 1 package rows20220203_8f5d420b-3348-4002-9a09-b05e8cbb35c9.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Iris 60 Second APFSODIUM FLUORIDEBenco Dental8f5d420b-3348-4002-9a09-b05e8cbb35c92022-02-02WarningsExact identifier
ndc (product): 66975-053

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN8f5d420b-3348-4002-9a09-b05e8cbb35c93
245593sodium fluoride 0.02 MG/MG Oral GelSCD8f5d420b-3348-4002-9a09-b05e8cbb35c93
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY8f5d420b-3348-4002-9a09-b05e8cbb35c93
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY8f5d420b-3348-4002-9a09-b05e8cbb35c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-053-1566975005315454 g in 1 BOTTLE, PLASTIC (66975-053-15) 454 g2016-05-010000-00-00NoNoCurrent