COLGATE PROCLINICAL - Sparkling Mint

Product NDC: 51442-543
11-digit product format: 514420543
Labeler code: 51442
Product ID: 51442-543_54178021-35d1-452f-91ae-79ac7ceaa606
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Canada
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-04-09
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 2 mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51442-543		D	Discontinued by firm	2026-10-05
excluded product	product	51442-543		I	Inactivated by FDA	2026-10-05
excluded product	product	51442-543		D	Discontinued by firm	2026-10-05
excluded package	package	51442-543	51442-543-16	D	Discontinued by firm	2026-10-05
excluded package	package	51442-543	51442-543-69	I	Inactivated by FDA	2026-10-05
excluded package	package	51442-543	51442-543-66	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 2 · 92 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51442-543-69	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51442-543-66	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51442-543-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51442-543-69	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51442-543-66	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51442-543-16	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51442-543-69	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51442-543-66	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51442-543-16	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51442-543-69	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51442-543-66	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51442-543-16	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51442-543-69	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51442-543-66	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51442-543-16	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51442-543-69	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51442-543-66	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51442-543-16	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51442-543-69	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51442-543-66	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51442-543-16	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51442-543-69	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51442-543-66	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51442-543-16	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51442-543-69	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51442-543-66	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51442-543-16	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51442-543-69	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51442-543-66	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51442-543-16	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51442-543-69	2019-10-29	C162847	48780-1	960f7f55-c017-8e05-e053-dbdaa90a074a	Colgate ® FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51442-543-69	COLGATE PROCLINICAL - Sparkling Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1		4
51442-543-69	COLGATE PROCLINICAL - Sparkling Mint	113 g in 1 TUBE	PASTE, DENTIFRICE	113		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Cocamidopropyl Betaine	INACTIVE INGREDIENT	5OCF3O11KX	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Polyethylene Glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Sodium Tripolyphosphate	INACTIVE INGREDIENT	5HK03SA80J	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Sorbitol	INACTIVE INGREDIENT	506T60A25R	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Water	INACTIVE INGREDIENT	059QF0KO0R	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51442-543	COLGATE PROCLINICAL - SPARKLING MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE CANADA]	4	Legacy NDC, 2 package rows	20101221_29e935f4-e8cf-4518-8033-4377dcaf43ca.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	29e935f4-e8cf-4518-8033-4377dcaf43ca	4
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	29e935f4-e8cf-4518-8033-4377dcaf43ca	4
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	29e935f4-e8cf-4518-8033-4377dcaf43ca	4
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	29e935f4-e8cf-4518-8033-4377dcaf43ca	4
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	29e935f4-e8cf-4518-8033-4377dcaf43ca	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51442-543-69	51442054369	1 in 1 CARTON	Historical