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 4 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GingiCaine Gel, Mint Julep	GINGICAINE GEL, MINT JULEP FLABVOR	Gingi-Pak a Division of the Belport	6285fe10-08ba-8044-e053-2991aa0a8e8b	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Pina Colada	GINGICAINE GEL, PINA COLADA FLAVOR	Gingi-Pak a Division of the Belport	6284e1fe-be33-69bf-e053-2991aa0a90ab	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Chocolate Mint	GINGICAINE GEL, CHOCOLATE MINT FLAVOR	Gingi-Pak a Division of the Belport	6285c4f2-c139-49a9-e053-2991aa0a2b03	2026-06-29	Warnings	Exact identifier application number: M022
UltraCare Anesthetic Gel	BENZOCAINE	The Bellport Company, Inc. dba Gingi-Pak	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2026-06-26	Warnings	Exact identifier application number: M022
GingiCaine Gel	GINGICAINE GEL BANANA FLAVOR	Gingi-Pak a Division of the Belport	62857d06-a829-4efa-e053-2991aa0a6d15	2026-06-25	Warnings	Exact identifier application number: M022
GingiCaine Gel, Cotton Candy Flavor	GINGICAINE GEL, COTTON CANDY FLAVOR	Gingi-Pak a Division of the Belport	628515a5-175f-ac2c-e053-2991aa0a19ce	2026-06-25	Warnings	Exact identifier application number: M022
Perox-A-Mint Solution	HYDROGEN PEROXIDE	Sage Products, LLC	50823ff5-ad08-4449-bc4a-9a8ae25ec0d5	2026-06-24	Warnings	Exact identifier application number: M022
Antiseptic Oral Rinse	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	efff8bae-154d-46bc-8dd4-716800425663	2026-06-24		Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	8c6ac499-9bd2-4ea5-9f26-df7947bff4a6	2026-06-22	Warnings	Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	dcc37403-0192-4658-bb7a-059273ce0047	2026-06-22	Warnings	Exact identifier application number: M022
Toothache	POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE	Guchutang Biotechnology (Longyan) Co., Ltd	54ad2ceb-272f-e5ba-e063-6394a90aec5f	2026-06-20	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Delon Laboratories (1990) Ltd	d4aa09bf-8207-47dd-bc42-01e660da9438	2026-06-16	Warnings	Exact identifier application number: M022
TideFresh MOUTH SORE AND TOOTHACHE	BENZOCAINE 20% MOUTH SORE AND TOOTHACHE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	541e1814-c00e-efdf-e063-6394a90a41a1	2026-06-13	Warnings	Exact identifier application number: M022
Chloraseptic Sore Throat Max	PHENOL AND GLYCERIN	Prestige Brands Holdings, Inc.	882c940c-b3c3-4aa4-8d64-e4260f066ff4	2026-06-08	Warnings	Exact identifier application number: M022
Orazen	SODIUM MONOFLUOROPHOSPHATE	Orazen Inc	fa5b6bd8-443f-79e7-e053-6394a90a5513	2026-06-03	Warnings	Exact identifier application number: M022 ndc (product): 71927-102
Fishermans Friend Mixed Berry	MENTHOL	Lofthouse of Fleetwood	53391c4d-ee2d-ade3-e063-6394a90ac77d	2026-06-01	Warnings	Exact identifier application number: M022
Orajel Medicated for Toothache and Gum, Liquid	BENZOCAINE AND MENTHOL	Church & Dwight Co., Inc.	ac3d605d-241d-1a6f-e053-2a95a90ae391	2026-06-01	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	6140d487-d87c-4954-9247-83492bcc5738	2026-05-27	Warnings	Exact identifier application number: M022
Dolodent Maximum Strength	BENZOCAINE	Pharmadel LLC	351ecc2b-cc1a-2bbf-e063-6394a90a5c14	2026-05-26	Warnings	Exact identifier application number: M022
MOUTH ULCER	PANTHENOL	Guangzhou Shengli Shidai Cosmetics Co., Ltd.	5264f81c-bffe-4f6d-e063-6394a90ae3bf	2026-05-22	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