Orbitol Mint Flavored Fluoride Toothpaste

Product NDC
62685-231
11-digit product format
626850231
Labeler code
62685
Product ID
62685-231_f1134278-5566-6afa-e053-2995a90a62e4
Type
HUMAN OTC DRUG
Nonproprietary name
sodium monofluorophosphate
Dosage form
PASTE
Route
DENTAL
Labeler
tropical degil cosmetics industries ltd
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-27
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62685-231IInactivated by FDA2026-08-17
excluded packagepackage62685-23162685-231-04IInactivated by FDA2026-08-17

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62685-231-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62685-231-04f5e01cc5f278…a2eaf40c39c3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62685-231-041332a3947898…d4bfe170f9cd…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62685-231-04Orbitol Mint Flavored Fluoride Toothpaste1 in 1 BOXPASTE14
62685-231-04Orbitol Mint Flavored Fluoride Toothpaste145 g in 1 TUBEPASTE1454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62685-231ORBITOL MINT FLAVORED FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE [TROPICAL DEGIL COSMETICS INDUSTRIES LTD]4Legacy NDC, 2 package rows20240321_cd023cb9-0887-7841-e053-2995a90a78ca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62685-231-04626850231041 TUBE in 1 BOX (62685-231-04) > 145 g in 1 TUBE1 tube2021-09-270000-00-00NoNoCurrent