Home NDC 35000-728-84 Colgate Enamel Health Mouthwash
Product NDC 35000-728
Requested package NDC 35000-728-84
11-digit product format 350000728
Labeler code 35000
Product ID 35000-728_07c961b1-21e6-4fea-9880-b8093bac7829
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form RINSE
Route DENTAL
Labeler Colgate-Palmolive Company
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-01
Marketing end 0000-00-00
Substance SODIUM FLUORIDE
Active strength 0 mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-728 COLGATE ENAMEL HEALTH MOUTHWASH (SODIUM FLUORIDE) RINSE [COLGATE-PALMOLIVE COMPANY] 9 Legacy NDC 20231207_7e264195-b024-440b-bafc-1d200694fdb0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 35000-728-84 35000072884 250 mL in 1 BOTTLE (35000-728-84) 250 ml 2015-08-01 0000-00-00 No No Current