CTx3 Rinse

Product NDC
61578-301
Requested package NDC
61578-301-01
11-digit product format
615780301
Labeler code
61578
Product ID
61578-301_df3e49c7-6a95-b6db-e053-2995a90a00b8
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61578-30161578-301-01DDiscontinued by firm2026-10-05

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…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 conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61578-301-012024-01-30Maintenance Rinse
61578-301-022024-01-30Maintenance Rinse
61578-301-012022-05-17Maintenance Rinse
61578-301-022022-05-17Maintenance Rinse
61578-301-012019-11-27Maintenance Rinse
61578-301-022019-11-27Maintenance Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61578-301-01CTx3 RinseMint473 mL in 1 BOTTLE, PLASTICRINSE4733
61578-301-02CTx3 RinseMint59 mL in 1 BOTTLE, PLASTICRINSE593

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
WATERINACTIVE INGREDIENT059QF0KO0RCTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [ORAL BIOTECH]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECTX3 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
NDCDashboard titleSPL versionValidationDashboard ZIP
61578-301CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC]3Legacy NDC, 2 package rows20230102_aa61834a-ff12-4c31-828f-43b1292fef3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486534CTx3 0.05 % Oral RinsePSNaa61834a-ff12-4c31-828f-43b1292fef3d3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNaa61834a-ff12-4c31-828f-43b1292fef3d3
1486534sodium fluoride 0.5 MG/ML Mouthwash [CTx3 Rinse]SBDaa61834a-ff12-4c31-828f-43b1292fef3d3
240698sodium fluoride 0.5 MG/ML MouthwashSCDaa61834a-ff12-4c31-828f-43b1292fef3d3
1486534CTx3 Rinse (fluoride ion 0.226 MG/ML ) MouthwashSYaa61834a-ff12-4c31-828f-43b1292fef3d3
1486534CTx3 Rinse 0.05 % MouthwashSYaa61834a-ff12-4c31-828f-43b1292fef3d3
1486534CTx3 Rinse 0.5 MG/ML MouthwashSYaa61834a-ff12-4c31-828f-43b1292fef3d3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYaa61834a-ff12-4c31-828f-43b1292fef3d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61578-301-0161578030101473 mL in 1 BOTTLE, PLASTIC (61578-301-01) 473 ml2012-05-010000-00-00NoNoCurrent