Home NDC 66969-6013 Oral Dent
Product NDC 66969-6013
11-digit product format 669696013
Labeler code 66969
Product ID 66969-6013_42347a25-20e2-4347-ac47-8f0d163b3c6e
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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66969-6013-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66969-6013-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66969-6013-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66969-6013-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66969-6013-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66969-6013-3 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66969-6013-3 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66969-6013-3 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66969-6013-3 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66969-6013-3 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66969-6013-3 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66969-6013-3 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66969-6013-3 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66969-6013-3 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66969-6013-3 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66969-6013-3 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66969-6013-3 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66969-6013-3 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66969-6013-3 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66969-6013-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66969-6013-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66969-6013-3 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66969-6013-3 Oral DentFresh Mint 1000 mL in 1 BOTTLE MOUTHWASH 1000 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EUCALYPTOL ACTIVE INGREDIENT RV6J6604TK ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 MENTHOL ACTIVE INGREDIENT L7T10EIP3A ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 THYMOL ACTIVE INGREDIENT 3J50XA376E ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 EUCALYPTOL ACTIVE MOIETY RV6J6604TK ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 MENTHOL ACTIVE MOIETY L7T10EIP3A ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 THYMOL ACTIVE MOIETY 3J50XA376E ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66969-6013 ORAL DENT FRESH MINT (EUCALYPTOL, THYMOL, METHYL SALICYLATE, MENTHOL) MOUTHWASH [INTERNATIONAL COSMETICS LTD.] 2 Legacy NDC, 1 package rows 20140315_6606bc46-cc6a-4e1a-babf-dde5765a6a06.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 66969-6013-3 66969601303 1000 mL in 1 BOTTLE 1000 ml Historical