Home NDC 69108-001 smilecare
Product NDC 69108-001
11-digit product format 691080001
Labeler code 69108
Product ID 69108-001_26bc01dd-3752-48a4-bb65-a04867b0d414
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Shantou MContinents Trading Co, LTD
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-06-01
Marketing end 0000-00-00
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 64 mg/8g
NDC exclude flag No
Listing certified through 2019-12-31
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 · 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 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 69108-001-01 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69108-001-01 smilecare 8 g in 1 TUBE PASTE, DENTIFRICE 8 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 LIMONENE, (+/-)- INACTIVE INGREDIENT 9MC3I34447 SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE INACTIVE INGREDIENT E1W4N241FO SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69108-001 SMILECARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SHANTOU MCONTINENTS TRADING CO, LTD] 1 Legacy NDC, 1 package rows 20140715_bf34b677-1cda-41fe-a9ad-2ea4a6695b73.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 69108-001-01 69108000101 8 g in 1 TUBE 8 g Historical