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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

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
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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d3	12

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PERIOSCIENCES HYDRATING AO ProToothpaste	PERIOSCIENCES LLC \| Chemolee Lab Corp	2026-02-09	HUMAN OTC DRUG LABEL	12