Topical 60 Sec Sodium Fluoride

Product NDC
50227-0511
11-digit product format
502270511
Labeler code
50227
Product ID
50227-0511_b8904fb7-2ab1-4fed-9d64-9c0d03f0bfbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Patterson Dental Supply Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-04-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
123 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct50227-0511IInactivated by FDA2026-08-07
excluded packagepackage50227-051150227-0511-6IInactivated by FDA2026-08-07

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 · 38 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 packagepackage50227-0511-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50227-0511-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50227-0511-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50227-0511-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50227-0511-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50227-0511-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50227-0511-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50227-0511-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50227-0511-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50227-0511-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50227-0511-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50227-0511-6557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50227-0511-68af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50227-0511-6834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50227-0511-61332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50227-0511-6fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50227-0511-686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50227-0511-6bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50227-0511-68dfbde2a14a4…c9ff85d89658…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50227-0511-62021-01-29C16284748780-1ba0f9c33-3897-a910-e053-dadaa90a0b85Patterson ® 60-Second Foam Fluoride Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50227-0511-6Topical 60 Sec Sodium Fluoride Mint125 g in 1 CANISTERAEROSOL, FOAM1252
50227-0511-6Topical 60 Sec Sodium Fluoride Mint1 in 1 BOXAEROSOL, FOAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7TOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
Fluoride IonACTIVE MOIETYQ80VPU408OTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
APAFLURANEINACTIVE INGREDIENTR40P36GDK6TOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
BenzaldehydeINACTIVE INGREDIENTTA269SD04TTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67OTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VLTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1
Sodium Phosphate, Monobasic, MonohydrateINACTIVE INGREDIENT593YOG76RNTOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50227-0511TOPICAL 60 SEC SODIUM FLUORIDE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [PATTERSON DENTAL SUPPLY INC]2Legacy NDC, 2 package rows20190116_3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248389sodium fluoride 2.72 % Oral FoamPSN3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d2
248389sodium fluoride 27.2 MG/ML Oral FoamSCD3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d2
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d2
248389sodium fluoride 2.72 % Oral FoamSY3f6c7e3d-2dfd-4869-95db-2bd0640e8c2d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50227-0511-650227051106125 g in 1 CANISTER125 gHistorical