Home NDC 11527-016 Dr. Sheffield Fluoride Anticavity
Product NDC 11527-016
11-digit product format 115270016
Labeler code 11527
Product ID 11527-016_0e20a98a-7eef-41b9-8c46-7f9a067fa555
Type HUMAN OTC DRUG
Nonproprietary name Fluoride Anticavity Toothpaste
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Sheffield Pharmaceuticals LLC
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-01-02
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 2 mg/g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 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 11527-016-63 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 CARBOXYMETHYLCELLULOSE INACTIVE INGREDIENT 05JZI7B19X DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 PEG-6 STEARATE INACTIVE INGREDIENT 8LQC57C6B0 DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DR. SHEFFIELD FLUORIDE ANTICAVITY (FLUORIDE ANTICAVITY TOOTHPASTE) PASTE, DENTIFRICE [FARIA LLC DBA SHEFFIELD PHARMACEUTCIALS] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11527-016-63 11527001663 1 TUBE in 1 CARTON (11527-016-63) > 85 g in 1 TUBE 1 tube 2006-01-02 0000-00-00 No No Current