CTx3 Rinse

Product NDC: 61578-302
11-digit product format: 615780302
Labeler code: 61578
Product ID: 61578-302_f127e236-5205-948b-e053-2a95a90ab740
Type: HUMAN OTC DRUG
Nonproprietary name: Anticaries
Dosage form: RINSE
Route: DENTAL
Labeler: Dental Alliance Holdings LLC
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 226 ug/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61578-302		I	Inactivated by FDA		2026-10-05
excluded package	package	61578-302	61578-302-01	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 1 · 42 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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`1332a3947898…`	`d4bfe170f9cd…`
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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`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	61578-302-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61578-302-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61578-302-01	`110d247fa046…`	`a55b01930146…`

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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61578-302-01	2024-01-30	C162847	48780-1	9855e2a2-4da3-60a7-e053-dbdaa90a05bd	Maintenance Rinse
61578-302-01	2022-05-17	C162847	48780-1	9855e2a2-4da3-60a7-e053-dbdaa90a05bd	Maintenance Rinse
61578-302-01	2019-11-27	C162847	48780-1	9855e2a2-4da3-60a7-e053-dbdaa90a05bd	Maintenance Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61578-302-01	CTx3 RinseCitrus	473 mL in 1 BOTTLE, PLASTIC	RINSE	473		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61578-302	CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]	3	Legacy NDC, 1 package rows	20230102_aa61834a-ff12-4c31-828f-43b1292fef3d.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
1486534	CTx3 0.05 % Oral Rinse	PSN	aa61834a-ff12-4c31-828f-43b1292fef3d	3
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	aa61834a-ff12-4c31-828f-43b1292fef3d	3
1486534	sodium fluoride 0.5 MG/ML Mouthwash [CTx3 Rinse]	SBD	aa61834a-ff12-4c31-828f-43b1292fef3d	3
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	aa61834a-ff12-4c31-828f-43b1292fef3d	3
1486534	CTx3 Rinse (fluoride ion 0.226 MG/ML ) Mouthwash	SY	aa61834a-ff12-4c31-828f-43b1292fef3d	3
1486534	CTx3 Rinse 0.05 % Mouthwash	SY	aa61834a-ff12-4c31-828f-43b1292fef3d	3
1486534	CTx3 Rinse 0.5 MG/ML Mouthwash	SY	aa61834a-ff12-4c31-828f-43b1292fef3d	3
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	aa61834a-ff12-4c31-828f-43b1292fef3d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61578-302-01	61578030201	473 mL in 1 BOTTLE, PLASTIC (61578-302-01)	473 ml	2012-05-01	0000-00-00	No	No	Current