Dental Clinic 2080 Cavity Protection

Product NDC: 67225-0001
11-digit product format: 672250001
Labeler code: 67225
Product ID: 67225-0001_a8085ef0-28a1-4643-94f6-1afdd8701f6f
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate
Dosage form: PASTE
Route: DENTAL
Labeler: Aekyung Industrial Co., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-04-01
Marketing end: 0000-00-00
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 0 g/160g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67225-0001		I	Inactivated by FDA	2026-10-05
excluded product	product	67225-0001		I	Inactivated by FDA	2026-10-05
excluded package	package	67225-0001	67225-0001-2	I	Inactivated by FDA	2026-10-05
excluded package	package	67225-0001	67225-0001-1	I	Inactivated by FDA	2026-10-05

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 2 · 88 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67225-0001-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67225-0001-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67225-0001-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67225-0001-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67225-0001-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67225-0001-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67225-0001-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67225-0001-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67225-0001-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67225-0001-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67225-0001-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67225-0001-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67225-0001-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67225-0001-1	`302b2466d912…`	`e7b80fea0513…`
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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67225-0001-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67225-0001-1	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67225-0001-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67225-0001-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67225-0001-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67225-0001-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67225-0001-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67225-0001-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67225-0001-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67225-0001-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67225-0001-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67225-0001-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67225-0001-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67225-0001-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67225-0001-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67225-0001-1	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67225-0001-2	2020-01-31	C162847	48780-1	9d75b9d0-2011-f424-e053-dadaa90a57ce	f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e
67225-0001-1	2019-11-27	C162847	48780-1	9855d018-d6e5-cd31-e053-dbdaa90ab51a	b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67225-0001-2	Dental Clinic 2080 Cavity Protection	1 in 1 PACKAGE	PASTE	1	4
67225-0001-2	Dental Clinic 2080 Cavity Protection	160 g in 1 TUBE	PASTE	160	4
67225-0001-1	Dental Clinic 2080 Cavity Protection	120 g in 1 TUBE	PASTE	120	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.]	3
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67225-0001	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG INDUSTRIAL CO., LTD.]	4	Legacy NDC, 2 package rows	20160718_f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e.zip
67225-0001	DENTAL CLINIC 2080 CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG IND. CO., LTD.]	1	Legacy NDC, 1 package rows	20130107_b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80.zip

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
1117211	sodium monofluorophosphate 0.75 % Toothpaste	PSN	f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e	4
1117211	sodium monofluorophosphate 0.0075 MG/MG Toothpaste	SCD	f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e	4
1117211	sodium monofluorophosphate 0.75 % (fluoride 0.13 % ) Toothpaste	SY	f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e	4
1117211	sodium monofluorophosphate 0.75 % Toothpaste	SY	f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e	4
1117211	sodium monofluorophosphate 0.75 % Toothpaste	PSN	b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80	1
1117211	sodium monofluorophosphate 0.0075 MG/MG Toothpaste	SCD	b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80	1
1117211	sodium monofluorophosphate 0.75 % (fluoride 0.13 % ) Toothpaste	SY	b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80	1
1117211	sodium monofluorophosphate 0.75 % Toothpaste	SY	b9f48a5f-b2a9-4e36-ae67-539d6c0a1f80	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
67225-0001-1	67225000101	120 g in 1 TUBE	120 g	Historical
67225-0001-2	67225000102	1 in 1 PACKAGE		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Monofluorophosphate - Aekyung Industrial Co., Ltd. \| Aekyung Ind. Co., Ltd._Chungyang Factory	Aekyung Industrial Co., Ltd. \| Aekyung Ind. Co., Ltd._Chungyang Factory	2016-07-14	HUMAN OTC DRUG LABEL	4
Dental Clinic 2080 Cavity Protection - Aekyung Ind. Co., Ltd.	Aekyung Ind. Co., Ltd.	2012-12-11	HUMAN OTC DRUG LABEL	1