FDA.reportPublic FDA data

PERIOSCIENCES HYDRATING AO Pro

Product NDC
53238-003
11-digit product format
532380003
Labeler code
53238
Product ID
53238-003_4a6b78e0-06ee-dd20-e063-6394a90a3a4b
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
PERIOSCIENCES LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-27
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53238-003-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53238-003-900efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.3 mg/mL

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
5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53238-003-90PERIOSCIENCES HYDRATING AO Pro90 mL in 1 TUBEPASTE, DENTIFRICE9012
53238-003-90PERIOSCIENCES HYDRATING AO Pro1 in 1 CARTONPASTE, DENTIFRICE112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
ETHYL LAUROYL ARGINATE HYDROCHLORIDEINACTIVE INGREDIENTXPD6ZY79TBPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
FERULIC ACIDINACTIVE INGREDIENTAVM951ZWSTPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3APERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PHLORETININACTIVE INGREDIENTS5J5OE47MKPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EPERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53238-003PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC]11Current NDC, Legacy NDC, 2 package rows20250130_5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3.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 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
TOTAL TP CLEAN MINT PSTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-05WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIESSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRYSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-04WarningsExact identifier
application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide WhiteningSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53238-003-90532380003901 TUBE in 1 CARTON (53238-003-90) / 90 mL in 1 TUBE1 tube2013-05-270000-00-00NoNoCurrent