Home NDC 61578-203 CTx4 Gel 1100
Product NDC 61578-203
11-digit product format 615780203
Labeler code 61578
Product ID 61578-203_df3e4bdc-62fb-0e6f-e053-2a95a90aa179
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form GEL, DENTIFRICE
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 1100 ug/g
NDC exclude flag No
Listing certified through 2023-12-31
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 · 36 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61578-203-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61578-203-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61578-203-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61578-203-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61578-203-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61578-203-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61578-203-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61578-203-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61578-203-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61578-203-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61578-203-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61578-203-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 61578-203-01 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 61578-203-01 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 61578-203-01 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 61578-203-01 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 61578-203-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61578-203-01 I Inactivated by FDA 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) INACTIVE INGREDIENT 7Q6P4JN1QT CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 SACCHARIN INACTIVE INGREDIENT FST467XS7D CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E CTX4 GEL 1100 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE CTX4 GEL 1100 GRAPE (SODIUM FLUORIDE) GEL, DENTIFRICE [ORAL BIOTECH] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61578-203-01 61578020301 56.699 g in 1 TUBE, WITH APPLICATOR (61578-203-01) 56.699 g 2012-05-01 0000-00-00 No No Current