Sodium Fluoride 5000 ppm

Product NDC: 35573-434
11-digit product format: 355730434
Labeler code: 35573
Product ID: 35573-434_70124866-ecd6-494c-90da-d1e2ad0c8100
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Burel Pharmaceuticals LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2020-02-28
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	35573-434		D	Discontinued by firm		2026-10-12
excluded package	package	35573-434	35573-434-51	D	Discontinued by firm		2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	35573-434		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35573-434	35573-434-51	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-434-51	GM - Gram	35573-434	0422d89d-0fc6-4491-a4c4-d73a02fdb480	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-434	SODIUM FLUORIDE 5000 PPM (SODIUM FLUORIDE) PASTE, DENTIFRICE [BUREL PHARMACEUTICALS LLC]	3	Legacy NDC	20221217_a7c63ceb-cd8a-4056-ae69-eb6b59248334.zip

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
35573-434-51	35573043451	1 TUBE in 1 CARTON (35573-434-51) > 51 g in 1 TUBE	1 tube	2020-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM FLUORIDE 5000 PPM DENTAL CREAM	Burel Pharmaceuticals LLC	2022-12-16	Human Prescription Drug Label	3