Oral Defense Fluoride Rinse

Product NDC: 52644-002
11-digit product format: 526440002
Labeler code: 52644
Product ID: 52644-002_bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Oral Defense, LLC
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-08-31
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/474mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52644-002		I	Inactivated by FDA	2026-10-12
excluded package	package	52644-002	52644-002-00	I	Inactivated by FDA	2026-10-12
excluded package	package	52644-002	52644-002-02	I	Inactivated by FDA	2026-10-12

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 · 66 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 package	package	52644-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52644-002-00	`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	52644-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52644-002-00	`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 package	package	52644-002-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52644-002-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52644-002-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52644-002-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52644-002-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52644-002-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52644-002-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52644-002-00	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52644-002-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52644-002-00	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52644-002-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52644-002-00	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e89db81-98c7-14a5-4bf2-ab0ee6489391	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52644-002-00	2019-11-27	C162847	48780-1	9855d018-dde4-cd31-e053-dbdaa90ab51a	Oral Defense Fluoride Rinse
52644-002-02	2019-11-27	C162847	48780-1	9855d018-dde4-cd31-e053-dbdaa90ab51a	Oral Defense Fluoride Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52644-002-00	Oral Defense Fluoride Rinse	474 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	474		12
52644-002-02	Oral Defense Fluoride Rinse	60 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	60		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
MINT	INACTIVE INGREDIENT	FV98Z8GITP	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
NATAMYCIN	INACTIVE INGREDIENT	8O0C852CPO	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52644-002	ORAL DEFENSE FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [ORAL DEFENSE, LLC]	12	Legacy NDC, 2 package rows	20130514_59a1f399-3609-4eef-b635-1f526cd75819.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	59a1f399-3609-4eef-b635-1f526cd75819	12
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	59a1f399-3609-4eef-b635-1f526cd75819	12
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	59a1f399-3609-4eef-b635-1f526cd75819	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52644-002-00	52644000200	474 mL in 1 BOTTLE, PLASTIC	474 ml	Historical
52644-002-02	52644000202	60 mL in 1 BOTTLE, PLASTIC	60 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oral Defense Fluoride Rinse	Oral Defense, LLC \| Coastal Products Company	2013-04-18	HUMAN OTC DRUG LABEL	12