Colgate Ultra Relief

Product NDC: 35000-992
11-digit product format: 350000992
Labeler code: 35000
Product ID: 35000-992_7b32fd85-c012-4697-8f7f-c5ec56d602a6
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE and POTASSIUM NITRATE
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-10-16
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: 2 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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	35000-992		D	Discontinued by firm		2026-10-15
excluded package	package	35000-992	35000-992-21	D	Discontinued by firm		2026-10-15

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35000-992-21	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35000-992-21	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-992	COLGATE ULTRA RELIEF (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]	2	Legacy NDC	20250116_1a3026a6-bc34-4dfe-bdf7-84e1ef43480c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-992-21	35000099221	1 TUBE in 1 CARTON (35000-992-21) > 60 g in 1 TUBE	1 tube	2020-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Ultra Relief	Colgate-Palmolive Company \| Mission Hills, S.A. de C.V.	2020-10-19	HUMAN OTC DRUG LABEL	2