FDA.reportPublic FDA data

Fluoride

Product NDC
80143-001
Requested package NDC
80143-001-02
11-digit product format
801430001
Labeler code
80143
Product ID
80143-001_d3882ed7-e342-0e8d-e053-2a95a90ac369
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste Tablets
Dosage form
TABLET, CHEWABLE
Route
DENTAL
Labeler
Henan Dailygreen Trade Co.,Ltd.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-06-24
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 1/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80143-00180143-001-02IInactivated by FDA2026-10-05

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80143-001-01Fluoride Toothpaste Tablets
80143-001-02Fluoride Toothpaste Tablets
80143-001-03Fluoride Toothpaste Tablets
80143-001-04Fluoride Toothpaste Tablets
80143-001-05Fluoride Toothpaste Tablets
80143-001-06Fluoride Toothpaste Tablets
80143-001-07Fluoride Toothpaste Tablets
80143-001-08Fluoride Toothpaste Tablets
80143-001-09Fluoride Toothpaste Tablets
80143-001-10Fluoride Toothpaste Tablets
80143-001-11Fluoride Toothpaste Tablets
80143-001-12Fluoride Toothpaste Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80143-001-01Fluoride60 in 1 BOTTLE, GLASSTABLET, CHEWABLE603
80143-001-02Fluoride62 in 1 BOTTLE, GLASSTABLET, CHEWABLE623
80143-001-03Fluoride120 in 1 BOTTLE, GLASSTABLET, CHEWABLE1203
80143-001-04Fluoride60 in 1 TUBETABLET, CHEWABLE603
80143-001-05Fluoride90 in 1 TUBETABLET, CHEWABLE903
80143-001-06Fluoride120 in 1 TUBETABLET, CHEWABLE1203
80143-001-07Fluoride30 in 1 CARTONTABLET, CHEWABLE303
80143-001-08Fluoride60 in 1 CARTONTABLET, CHEWABLE603
80143-001-09Fluoride2 in 1 BAGTABLET, CHEWABLE23
80143-001-10Fluoride62 in 1 BAGTABLET, CHEWABLE623
80143-001-11Fluoride120 in 1 BAGTABLET, CHEWABLE1203
80143-001-12Fluoride1000 in 1 BAGTABLET, CHEWABLE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80143-001FLUORIDE (TOOTHPASTE TABLETS) TABLET, CHEWABLE [HENAN DAILYGREEN TRADE CO.,LTD.]3Legacy NDC, 12 package rows20211220_ad447c9a-6f0f-7fef-e053-2995a90a055f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80143-001-028014300010262 TABLET, CHEWABLE in 1 BOTTLE, GLASS (80143-001-02) 2020-06-240000-00-00NoNoCurrent