Oral Dent

Product NDC
66969-6023
11-digit product format
669696023
Labeler code
66969
Product ID
66969-6023_980e99ae-8be7-48fa-af5f-33972ee3b795
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Thymol, Methyl Salicylate, Menthol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
International Cosmetics Ltd.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-10
Marketing end
0000-00-00
Substance
EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL
Active strength
0 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66969-6023IInactivated by FDA2026-10-05
excluded packagepackage66969-602366969-6023-3IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66969-6023-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66969-6023-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66969-6023-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66969-6023-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66969-6023-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66969-6023-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66969-6023-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66969-6023-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66969-6023-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66969-6023-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66969-6023-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66969-6023-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66969-6023-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66969-6023-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66969-6023-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66969-6023-3IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66969-6023-3IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66969-6023-3IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66969-6023-3IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66969-6023-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66969-6023-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66969-6023-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66969-6023-32020-01-31C16284748780-19d75b9d1-2592-f424-e053-dadaa90a57ceOral Dent Citrus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66969-6023-3Oral DentCitrus500 mL in 1 BOTTLEMOUTHWASH5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
THYMOLACTIVE INGREDIENT3J50XA376EORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
MENTHOLACTIVE MOIETYL7T10EIP3AORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
THYMOLACTIVE MOIETY3J50XA376EORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66969-6023ORAL DENT CITRUS (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.]1Legacy NDC, 1 package rows20140315_9b6bab9b-1dba-4065-87e4-eab9a01cbe5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN9b6bab9b-1dba-4065-87e4-eab9a01cbe5c1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD9b6bab9b-1dba-4065-87e4-eab9a01cbe5c1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY9b6bab9b-1dba-4065-87e4-eab9a01cbe5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66969-6023-366969602303500 mL in 1 BOTTLE500 mlHistorical