Home NDC 53238-003 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53238-003-90 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53238-003-90 0efc9e666f02…f202fb6c5f17…
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 PERIOSCIENCES HYDRATING AO Pro
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53238-003-90 PERIOSCIENCES HYDRATING AO Pro 90 mL in 1 TUBE PASTE, DENTIFRICE 90 12 53238-003-90 PERIOSCIENCES HYDRATING AO Pro 1 in 1 CARTON PASTE, DENTIFRICE 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 FLUORIDE ION ACTIVE MOIETY Q80VPU408O PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 ETHYL LAUROYL ARGINATE HYDROCHLORIDE INACTIVE INGREDIENT XPD6ZY79TB PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 FERULIC ACID INACTIVE INGREDIENT AVM951ZWST PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 MENTHOL INACTIVE INGREDIENT L7T10EIP3A PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 PHLORETIN INACTIVE INGREDIENT S5J5OE47MK PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 SODIUM ASCORBYL PHOSPHATE INACTIVE INGREDIENT 836SJG51DR PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 SODIUM METHYL COCOYL TAURATE INACTIVE INGREDIENT JVL98CG53G PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53238-003 PERIOSCIENCES HYDRATING AO PRO (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PERIOSCIENCES LLC] 11 Current NDC, Legacy NDC, 2 package rows 20250130_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 21 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HISMILE SODIUM FLUORIDE HISMILE PTY LTD 1de591d9-9cab-e63d-e063-6394a90ac8eb 2026-01-15 Warnings Exact identifier application number: M021 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 20e1603e-bcd1-6a5e-e063-6294a90ad1db 2026-01-15 Warnings Exact identifier application number: M021 Hismile CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE HISMILE PTY LTD 1e725b7e-accc-f51c-e063-6394a90a455c 2026-01-15 Warnings Exact identifier application number: M021 Enamelon Preventive Treatment STANNOUS FLUORIDE Premier Dental Products Company 04c3f178-7905-404d-9ac2-67c453287ddf 2026-01-13 Warnings Exact identifier application number: M021 Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ARU CAVITY PROTECTION SODIUM FLUORIDE Ashtel Studios, Inc. 97bd2934-4bff-4fdb-9199-fcdc0f77fada 2026-01-13 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Cinnamon SODIUM FLUORIDE Chattem, Inc. f2952ca5-c1c3-42fc-82a4-08662286be44 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Wild Watermelon SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) Chattem, Inc. bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Pineapple Punch SODIUM FLUORIDE Chattem, Inc. 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b 2026-01-12 Warnings Exact identifier application number: M021 Botao Kids Strawberry Flavored with Fluoride BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE Peer Pharm Ltd. 48b8d884-5e15-4145-8521-ae9ee482e392 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53238-003-90 53238000390 1 TUBE in 1 CARTON (53238-003-90) / 90 mL in 1 TUBE 1 tube 2013-05-27 0000-00-00 No No Current