Orazen

Product NDC: 71927-102
11-digit product format: 719270102
Labeler code: 71927
Product ID: 71927-102_536042f4-24c3-0778-e063-6294a90aaf42
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: PASTE
Route: DENTAL
Labeler: Orazen Inc
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-04-01
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: .1 g/100g
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71927-102-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71927-102-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-102-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-102-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-102-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-102-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-102-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-102-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-102-01	U	Excluded because listing certification expired	`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: Orazen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	.1 g/100g

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
fa5b6bd8-443f-79e7-e053-6394a90a5513	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71927-102-01	2025-01-30	C162847	48780-1	2cef2736-a85f-d83d-e063-dadaa90ab31f	Orazen Kids Anticavity Toothpaste
71927-102-01	2025-01-30	C162847	48780-1	2cef2736-a85f-d83d-e063-dadaa90ab31f	Orazen Kids Anticavity Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71927-102-01	Orazen	28 g in 1 TUBE	PASTE	28		2
71927-102-01	Orazen	1 in 1 POUCH	PASTE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71927-102	ORAZEN (SODIUM MONOFLUOROPHOSPHATE) PASTE [ORAZEN INC]	2	Current NDC, 2 package rows	20230814_fa5b6bd8-443f-79e7-e053-6394a90a5513.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 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AHLO PRO Healthy Gums	CETYLPYRIDINIUM CHLORIDE	Gervest USA Inc	4f5a0ccb-26e5-ebb6-e063-6394a90abbc5	2026-04-13	Warnings	Exact identifier application number: M022
Crest Scope Original Clean Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f1db6f4-acd7-a665-e063-6294a90a826b	2026-04-10	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	Walgreens	1e845299-178e-49ce-9d08-7e9d548a5a6d	2026-04-09	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Walgreens	67bed85e-e1e2-49ba-98d6-dfd4e1cd6856	2026-04-08	Warnings	Exact identifier application number: M022
Health-Tec Topical Anesthetic	BENZOCAINE	Dental Health Products, Inc.	5eb437c5-a2af-4c0d-b7b9-9ab7d093db85	2026-04-06	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	269b9e7f-c5c8-4023-a3ea-e39040ade271	2026-04-06	Warnings	Exact identifier application number: M022
Health-Tec Topical Anesthetic	BENZOCAINE	Dental Health Products, Inc.	c3fb6705-c647-4fe6-9aca-29735d01d8ea	2026-04-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	2026-04-01	Warnings	Exact identifier application number: M022
CloSYS Silver Healthy Gums	CETYLPYRIDINIUM CHLORIDE	Rowpar Pharmaceuticals, Inc.	11fd3f31-ee0c-43d2-a856-929d1298277c	2026-04-01	Warnings	Exact identifier application number: M022
Crest Pro-Health Bold Fresh Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	5692c0ce-a914-08c4-e063-6394a90adf15	2026-04-01	Warnings	Exact identifier application number: M022
Anticavity Fluoride	SODIUM FLUORIDE AND ACIDULATED PHOSPHATE	Family Dollar (FAMILY WELLNESS)	1666fff6-9a8b-40f9-ae53-914152db386b	2026-04-01	Warnings	Exact identifier application number: M022
Sodium Chloride Normal Salt	SODIUM CHLORIDE	TWIN MED LLC	10230c8a-e5e5-44f1-b41d-80930899d6b9	2026-03-31	Warnings	Exact identifier application number: M022
Sootheez Birthday Cake	PECTIN	Primrose Candy Co.	4e5d8234-0521-0c8a-e063-6294a90ae62d	2026-03-31	Warnings	Exact identifier application number: M022
Sootheez Watermelon Mint	PECTIN	Primrose Candy Co.	4e5e4342-4647-ef25-e063-6394a90a1d13	2026-03-31	Warnings	Exact identifier application number: M022
PERIOGELX	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	4e5a67a0-f989-50df-e063-6394a90aae73	2026-03-31	Warnings	Exact identifier application number: M022
Periogel	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	1f9686b1-eac2-65b7-e063-6394a90a74fb	2026-03-31	Warnings	Exact identifier application number: M022
PERIOGELX	HYDROGEN PEROXIDE	PERIO PROTECT, LLC	1f7ecd75-bb59-2f4f-e063-6294a90ace84	2026-03-31	Warnings	Exact identifier application number: M022
Baza Protect	ZINC OXIDE AND DIMETHICONE	Coloplast Corp	ed63df26-3879-46df-8e09-10be569b25be	2026-03-31	Warnings	Exact identifier application number: M022
Benzocaine 20%	BENZOCAINE 20%	PAI Holdings, LLC dba PAI Pharma	7fbce9a5-00dc-4a4a-8709-ab752bdf2f59	2026-03-25	Warnings	Exact identifier application number: M022
Kroger Extra Whitening	FLUORIDE	Kroger	e704c690-1383-4cd6-be85-28bdd9ff936b	2026-03-24	Warnings	Exact identifier application number: M022

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	fa5b6bd8-443f-79e7-e053-6394a90a5513	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	fa5b6bd8-443f-79e7-e053-6394a90a5513	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	fa5b6bd8-443f-79e7-e053-6394a90a5513	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	fa5b6bd8-443f-79e7-e053-6394a90a5513	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	fa5b6bd8-443f-79e7-e053-6394a90a5513	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	fa5b6bd8-443f-79e7-e053-6394a90a5513	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71927-102-01	71927010201	1 TUBE in 1 POUCH (71927-102-01) / 28 g in 1 TUBE	1 tube	2023-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orazen Kids Anticavity Toothpaste	Orazen Inc \| YANGZHOU One & Only	2026-06-03	HUMAN OTC DRUG LABEL	3