Colgate

Product NDC: 35000-919
11-digit product format: 350000919
Labeler code: 35000
Product ID: 35000-919_0d589e2c-3d03-4c65-b2ce-bc197b954fb4
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: GEL, DENTIFRICE
Route: DENTAL
Labeler: Colgate-Palmolive Company
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-03-01
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	35000-919	35000-919-46	D	Discontinued by firm	2026-10-15
excluded package	package	35000-919	35000-919-64	D	Discontinued by firm	2026-10-15
excluded package	package	35000-919	35000-919-79	D	Discontinued by firm	2026-10-15
excluded package	package	35000-919	35000-919-82	D	Discontinued by firm	2026-10-15
excluded package	package	35000-919	35000-919-92	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 · 45 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	35000-919-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-919-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-919-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-919-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	35000-919-46	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-919-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-919-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-919-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-919-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	35000-919-46	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-919-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-919-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-919-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-919-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	35000-919-46	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-919-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-919-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-919-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-919-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	35000-919-46	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-919-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-919-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-919-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-919-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	35000-919-46	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-919-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-919-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-919-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-919-82	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	35000-919-46	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-919-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-919-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-919-64	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-919-82	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	35000-919-46	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-919-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-919-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-919-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-919-82	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	35000-919-46	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-919-79	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-919-92	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-919-64	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-919-82	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	35000-919-46	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Colgate
Brand name suffix: Sparkling White Mint Zing
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
545626	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c2fe62b-4905-4213-a85b-e073d8eeb741	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-919-46	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-46	ColgateSparkling White Mint Zing	130 g in 1 TUBE	GEL, DENTIFRICE	130	3
35000-919-48	ColgateSparkling White Mint Zing	226 g in 1 TUBE	GEL, DENTIFRICE	226	3
35000-919-48	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-58	ColgateSparkling White Mint Zing	70 g in 1 TUBE	GEL, DENTIFRICE	70	3
35000-919-58	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-60	ColgateSparkling White Mint Zing	170 g in 1 TUBE	GEL, DENTIFRICE	170	3
35000-919-60	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-64	ColgateSparkling White Mint Zing	181 g in 1 TUBE	GEL, DENTIFRICE	181	3
35000-919-64	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-69	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-69	ColgateSparkling White Mint Zing	113 g in 1 TUBE	GEL, DENTIFRICE	113	3
35000-919-79	ColgateSparkling White Mint Zing	79 g in 1 TUBE	GEL, DENTIFRICE	79	3
35000-919-79	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-82	ColgateSparkling White Mint Zing	232 g in 1 TUBE	GEL, DENTIFRICE	232	3
35000-919-82	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3
35000-919-92	ColgateSparkling White Mint Zing	141 g in 1 TUBE	GEL, DENTIFRICE	141	3
35000-919-92	ColgateSparkling White Mint Zing	1 in 1 CARTON	GEL, DENTIFRICE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35000-919	COLGATE SPARKLING WHITE MINT ZING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [COLGATE PALMOLIVE COMPANY]	3	Current NDC, Legacy NDC, 18 package rows	20241127_0c2fe62b-4905-4213-a85b-e073d8eeb741.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	ed617c7a-805c-4788-9bce-9b7fead4312d	2026-03-31	Warnings	Exact identifier application number: M021
Colgate Total Enamel Strength	STANNOUS FLUORIDE	Colgate-Palmolive Company	1f29c893-e7c5-4a0e-941b-c2634d821147	2026-03-25	Warnings	Exact identifier application number: M021
AP-24 Whitening	SODIUM MONOFLUOROPHOSPHATE	NSE Products, Inc.	57e9e68c-41dd-470b-80db-dfaedc0e2a0a	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369c0d44-6375-dcae-e063-6394a90a74d0	2026-03-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369bc785-fb77-a56d-e063-6394a90a2e6b	2026-03-24	Warnings	Exact identifier application number: M021
SensitiveToothpaste	ANTI SENSITIVETOOTHPASTE	Huain Best Trade Co., Ltd.	4db239f3-2ad7-3a5b-e063-6294a90a11a7	2026-03-23	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d6268c7-b273-1bbf-e053-2a91aa0a5d32	2026-03-17	Warnings	Exact identifier application number: M021
Natures Promise Childrens Fluoride Strawberry	SODIUM MONOFLUOROPHOSPHATE	Foodhold U.S.A.	81a4e196-8b2d-0745-e053-2991aa0a7de6	2026-03-16	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae8badf-f960-62fd-e054-00144ff8d46c	2026-03-11	Warnings	Exact identifier application number: M021
Stance	0.63% STANNOUS FLUORIDE CONCENTRATE RINSE	Elevate Oral Care	3ae71258-a8c2-6eb5-e054-00144ff88e88	2026-03-11	Warnings	Exact identifier application number: M021
Delta Travel Kit Comfort plus	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	d31e0920-4317-1e0c-e053-2a95a90aebeb	2026-03-11	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	CVS Pharmacy, Inc.	eac346d9-d9c1-4417-8193-390c7a0dcc2a	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6caf3f2e-70a2-4530-99fa-f5af7e4c511a	2026-03-10	Warnings	Exact identifier application number: M021
Amerfresh Toothpowder	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	1cacf93e-aa60-4717-87ab-0568a701a4f3	2026-03-10	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	CVS Pharmacy, Inc.	a51357df-6d55-4030-a5db-42da7ba54a37	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M021
Fluoride	FLUORIDE TOOTHPASTE	McKesson	4c482e45-0502-a93a-e063-6394a90aa961	2026-03-05	Warnings	Exact identifier application number: M021
Colgate Maximum Cavity Protection Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	0a1389f6-cac9-3d58-0744-c488abb0bbcc	2026-03-03	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Amazon.com Services LLC	349eca80-2e0c-409b-af29-3235fdc0695b	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Amazon.com Services LLC	03735abc-d1be-4ca0-a497-0a5c5f289402	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Old East Main Co.	f8036e2e-7541-4922-92b9-0d8319f7b64c	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	0c2fe62b-4905-4213-a85b-e073d8eeb741	3
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	0c2fe62b-4905-4213-a85b-e073d8eeb741	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	0c2fe62b-4905-4213-a85b-e073d8eeb741	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	0c2fe62b-4905-4213-a85b-e073d8eeb741	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	0c2fe62b-4905-4213-a85b-e073d8eeb741	3
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	0c2fe62b-4905-4213-a85b-e073d8eeb741	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
35000-919-46	35000091946	1 TUBE in 1 CARTON (35000-919-46) > 130 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-48	35000091948	1 TUBE in 1 CARTON (35000-919-48) / 226 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-58	35000091958	1 TUBE in 1 CARTON (35000-919-58) / 70 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-60	35000091960	1 TUBE in 1 CARTON (35000-919-60) / 170 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-64	35000091964	1 TUBE in 1 CARTON (35000-919-64) > 181 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-69	35000091969	1 TUBE in 1 CARTON (35000-919-69) / 113 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-79	35000091979	1 TUBE in 1 CARTON (35000-919-79) > 79 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-82	35000091982	1 TUBE in 1 CARTON (35000-919-82) > 232 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current
35000-919-92	35000091992	1 TUBE in 1 CARTON (35000-919-92) > 141 g in 1 TUBE	1 tube	2013-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colgate ® Sparkling White ® Mint Zing Fluoride Toothpaste Gel	Colgate-Palmolive Company \| Mission Hills, S.A. de C.V.	2026-06-24	HUMAN OTC DRUG LABEL	5