Home NDC 67225-0004 Dental Clinic 2080 Vita Care
Product NDC 67225-0004
11-digit product format 672250004
Labeler code 67225
Product ID 67225-0004_bc06a34a-8980-4078-88d1-d01d3bb020b5
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE
Route DENTAL
Labeler Aekyung Industrial Co., Ltd.
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-01
Marketing end 0000-00-00
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 0 g/120g
NDC exclude flag E
Listing certified through 2017-12-31
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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 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 67225-0004-1 Dental Clinic 2080 Vita Care 120 g in 1 TUBE PASTE 120 4 67225-0004-1 Dental Clinic 2080 Vita Care 1 in 1 PACKAGE PASTE 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 FLUORIDE ION ACTIVE MOIETY Q80VPU408O DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUG INDUSTRIAL CO., LTD.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67225-0004 DENTAL CLINIC 2080 VITA CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE [AEKYUNG INDUSTRIAL CO., LTD.] 4 Legacy NDC, 2 package rows 20160718_2e89595c-bd20-4704-8593-44a12623aebd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 67225-0004-1 67225000401 120 g in 1 TUBE 120 g Historical