Iris 60 Second APF

Product NDC
66975-050
11-digit product format
669750050
Labeler code
66975
Product ID
66975-050_d70c50cf-7e92-15be-e053-2a95a90a0713
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
5fa57e34-5827-4d37-a5dc-965750e5be50Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-050-15Iris 60 Second APF454 g in 1 BOTTLE, PLASTICGEL4545

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-050IRIS 60 SECOND APF (SODIUM FLUORIDE) GEL [BENCO DENTAL]5Current NDC, Legacy NDC, 1 package rows20220203_5fa57e34-5827-4d37-a5dc-965750e5be50.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 Dental5fa57e34-5827-4d37-a5dc-965750e5be502022-02-02WarningsExact identifier
ndc (product): 66975-050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN5fa57e34-5827-4d37-a5dc-965750e5be505
245593sodium fluoride 0.02 MG/MG Oral GelSCD5fa57e34-5827-4d37-a5dc-965750e5be505
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY5fa57e34-5827-4d37-a5dc-965750e5be505
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY5fa57e34-5827-4d37-a5dc-965750e5be505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-050-1566975005015454 g in 1 BOTTLE, PLASTIC (66975-050-15) 454 g2016-05-010000-00-00NoNoCurrent