Nupro Fluorides NaF Oral Solution

Product NDC: 65222-401
Requested package NDC: 65222-401-32
11-digit product format: 652220401
Labeler code: 65222
Product ID: 65222-401_0f84840f-31cb-431e-8741-338cfd4f7e80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: GEL
Route: DENTAL
Labeler: Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1974-01-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 20 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65222-401	65222-401-32	D	Discontinued by firm		2026-10-05

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 · 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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65222-401-32	2020-07-27	C162847	48780-1	ab0e2407-31f9-f274-e053-dbdaa90a6471	Nupro® Fluorides Neutral Sodium Fluoride (NaF) Oral Solution
65222-401-32	2020-07-22	C162847	48780-1	ab0e2407-31f9-f274-e053-dbdaa90a6471	Nupro® Fluorides Neutral Sodium Fluoride (NaF) Oral Solution

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65222-401-32	65222040132	7 g in 1 BOTTLE, PLASTIC (65222-401-32)	7 g	1974-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nupro® Fluorides Neutral Sodium Fluoride (NaF) Oral Solution	Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" \| Dentsply Caulk	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	3

Nupro Fluorides NaF Oral Solution

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#