Home NDC 41520-435-43 Anticavity
Product NDC 41520-435
Requested package NDC 41520-435-43
11-digit product format 415200435
Labeler code 41520
Product ID 41520-435_d6c409bd-5c7e-4720-b9c2-bf01a6773a96
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Foodhold U.S.As., LLC
Application part355
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-01
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
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 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 HYDROGEN PEROXIDE INACTIVE INGREDIENT BBX060AN9V ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [FOODHOLD U.S.AS., LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41520-435-43 41520043543 473 mL in 1 BOTTLE, PLASTIC (41520-435-43) 473 ml 2015-06-28 0000-00-00 No No Current