FDA.reportPublic FDA data

PERIOSCIENCES White Care AO Pro

Product NDC
53238-001
11-digit product format
532380001
Labeler code
53238
Product ID
53238-001_4a6b760a-db11-cbf8-e063-6394a90a6c6a
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
PERIOSCIENCES LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-13
Substance
SODIUM FLUORIDE
Active strength
.24 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PERIOSCIENCES White Care AO Pro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53238-001-90PERIOSCIENCES White Care AO Pro90 mL in 1 TUBEPASTE, DENTIFRICE907
53238-001-90PERIOSCIENCES White Care AO Pro1 in 1 CARTONPASTE, DENTIFRICE17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
FERULIC ACIDINACTIVE INGREDIENTAVM951ZWSTPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
HESPERETININACTIVE INGREDIENTQ9Q3D557F1PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
PHLORETININACTIVE INGREDIENTS5J5OE47MKPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
PUMMELOINACTIVE INGREDIENTET1TN5W71XPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
STEVIA REBAUDIANA WHOLEINACTIVE INGREDIENT6U422Y08O2PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53238-001PERIOSCIENCES WHITE CARE AO PRO (SODIUM FLUORIDE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]6Current NDC, Legacy NDC, 2 package rows20250130_092bdfa3-6267-439e-9320-e51b4805d1a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN092bdfa3-6267-439e-9320-e51b4805d1a17
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD092bdfa3-6267-439e-9320-e51b4805d1a17
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY092bdfa3-6267-439e-9320-e51b4805d1a17
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY092bdfa3-6267-439e-9320-e51b4805d1a17
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY092bdfa3-6267-439e-9320-e51b4805d1a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53238-001-90532380001901 TUBE in 1 CARTON (53238-001-90) / 90 mL in 1 TUBE1 tube2012-09-130000-00-00NoNoCurrent