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 5 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity and Gum with Cavity Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Health and Natural Beauty USA Corp	137d6935-19a3-499d-957c-820156eec7a5	2026-05-22	Warnings	Exact identifier application number: M022
SEXYTEETH MINTY T00THPASTE	SEXYTEETH MINTY TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51d288c1-fe86-ffe1-e063-6394a90ab4c4	2026-05-14	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier application number: M022
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier application number: M022
SEXYTEETH CHARCOAL T00THPASTE	SEXYTEETH CHARCOAL TOOTHPASTE	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	51ab8a9a-6c12-b13b-e063-6294a90ace2a	2026-05-12	Warnings	Exact identifier application number: M022
365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity	FLUORIDE	WHOLE FOODS	25bc7ab1-116d-143a-e063-6394a90aa970	2026-05-04	Warnings	Exact identifier application number: M022
Gingicaine Gel Strawberry	GINGICAINE GEL STRAWBERRY FLAVOR	Gingi-Pak a Division of the Belport	2fd37612-a28b-3aa1-e054-00144ff8d46c	2026-05-01	Warnings	Exact identifier application number: M022
3ECARE Dual formula WhiteningToothpaste Refill	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	501df1c7-4884-bb39-e063-6294a90aaf6a	2026-04-23	Warnings	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	1f10a72f-0b49-41cb-92f9-b0160d7664de	2026-04-22	Warnings	Exact identifier application number: M022
EverSmile AlignerFresh Enamel Guard	SODIUM FLUORIDE	Everbrands, Inc.	7b3d0114-dac0-4370-8545-922ec018018e	2026-04-21	Warnings	Exact identifier application number: M022
PREOP	HYDROGEN PEROXIDE	Everbrands, Inc.	cc5cdd29-92c1-4ce0-997e-eb624b288b09	2026-04-20	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	92747826-cf58-4406-b3b5-12f7c7077c2c	2026-04-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier application number: M022
Osstem S Sensitivity relief tooth	POTASSIUM NITRATE, SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8ab179-8f29-a7cf-e063-6294a90a0c22	2026-04-15	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum DetoxifyWinter Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6db58f-0b09-d155-e063-6394a90ae658	2026-04-14	Warnings	Exact identifier application number: M022
Lolleez Orange Mango	PECTIN	BFY LLC	4f6dec8b-078a-f321-e063-6294a90a248c	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Gum Restore Smooth Mint	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6e3b36-e565-7d27-e063-6294a90ae5ac	2026-04-14	Warnings	Exact identifier application number: M022
Crest Pro-Health Nightly Bacteria Shield	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	4f6ec1e0-c6b5-226f-e063-6294a90a8f14	2026-04-14	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