Colgate 5g and Toothbrush Dental Kit

Product NDC: 79940-004
11-digit product format: 799400004
Labeler code: 79940
Product ID: 79940-004_49788a32-5f1f-5e36-e063-6294a90a2f85
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: KIT
Labeler: FORMIA LIMITED
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-01-19
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 14 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
2025-04-01 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	79940-004-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
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	79940-004-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	79940-004-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
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	79940-004-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79940-004-00	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	79940-004-00	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
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	79940-004-00	U	Excluded because listing certification expired	`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 5g and Toothbrush Dental Kit
Listing expiration: 2027-12-31

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
0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	Available on FDA.report

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
79940-004-00	2025-06-23	C162847	48780-1	2cef2736-66d9-d83d-e063-dadaa90ab31f	Colgate 5g Toothpaste and Toothbrush Dental Kit
79940-004-00	2025-01-30	C162847	48780-1	2cef2736-66d9-d83d-e063-dadaa90ab31f	Colgate 5g Toothpaste and Toothbrush Dental Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79940-004-00	Colgate 5g and Toothbrush Dental Kit	1 in 1 KIT	KIT	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79940-004	COLGATE 5G AND TOOTHBRUSH DENTAL KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [FORMIA AIRLINE SUPPLIES LIMITED]	4	Current NDC, Legacy NDC, 1 package rows	20231101_0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13.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 2 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Flouride Rinse	SODIUM FLUORIDE	Your Military Exchanges	5f6f4125-6264-4724-bb7e-a6e100939b41	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M021
Colgate MaxFresh Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	7cb85fc4-573b-45d7-a430-f2fd17320c43	2026-08-26	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	8b210b6c-b712-4f14-906c-306922573a26	2026-08-26	Warnings	Exact identifier application number: M021
COLGATE 2IN1 ICY BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6aad9a91-ba1c-4a27-9269-ea8032feaad0	2026-08-26	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	59dff762-7f66-8bdc-e063-6294a90a9f18	2026-08-25	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Nice-Pak Products, LLC	c71d4064-f938-477b-9346-eb38be65390d	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M021
AIM Whitening with Baking Soda	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fd0b4-33ba-5764-e054-00144ff88e88	2026-08-25	Warnings	Exact identifier application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEAN	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	b1ada157-a9a0-4eec-83a2-6e448d7f12dc	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3ba04b55-38f9-76f3-e063-6394a90a3c03	2026-08-21	Warnings	Exact identifier application number: M021
Therabreath Deep Clean	STANNOUS FLUORIDE	Church & Dwight Co., Inc.	3c372f26-e0c4-0659-e063-6294a90ae9f9	2026-08-21	Warnings	Exact identifier application number: M021
TheraBreath	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	4b812a38-f7cb-51c8-e063-6394a90ab82c	2026-08-21	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Your Military Exchanges	eb95e0ca-a94c-41cb-9f54-6c64ed9a9733	2026-08-21	Warnings, Adverse reactions	Exact identifier application number: M021
Pop On Toothpaste.	POP ON TOOTHPASTE.	POPONSMILES,LLC	4a0edab5-ae36-91b5-e063-6294a90aa685	2026-08-21	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	188dc3ac-64c9-438e-858b-846f725c6ea0	2026-08-21	Warnings	Exact identifier application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT	STANNOUS FLUORIDE	Colgate-Palmolive Company	178d4535-fa57-4b53-b1f8-5c591f2ea9e7	2026-08-21	Warnings	Exact identifier application number: M021
freshSTART Anticavity fluoride toothpaste.	ANTICAVITY FLUORIDE TOOTHPASTE	Guangzhou Xinuo Technology Co., Ltd.	596432d5-3541-6dff-e063-6294a90a9d42	2026-08-19	Warnings	Exact identifier application number: M021
Colgate Sensitive ProRelief Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	8d9d485e-6efb-4bca-a779-9e8b0aeed14c	2026-08-18	Warnings	Exact identifier application number: M021
SprinJene Natural	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	e64cecc3-0845-4bdf-a449-d78248791ccf	2026-08-17	Warnings	Exact identifier application number: M021
ATOMY ANTICAVITY TOOTH	SODIUM MONOFLUOROPHOSPHATE	ATOMY CO., LTD.	592caccc-e3a9-9c66-e063-6394a90a26e3	2026-08-16	Warnings	Exact identifier application number: M021
SprinJene Health Boost	SODIUM MONOFLUOROPHOSPHATE	Health and Natural Beauty USA Corp	9be87bcd-403a-4d7e-8ded-9833249565d1	2026-08-14	Warnings	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	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79940-004-00	79940000400	1 KIT in 1 KIT (79940-004-00) * 5 g in 1 TUBE (79940-005-05)	1 kit	2021-01-19	0000-00-00	No	No	Current