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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Murchison Hume Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	b1a442e1-86cf-cba6-e053-2995a90a593a	2023-12-20	Warnings	Exact identifier application number: M021
United Airlines Polaris Kit with Colgate	SODIUM MONOFLUOROPHOSPHATE	Buzz Export Services Pty Ltd (Buzz Products)	de4564a4-1012-baad-e053-2a95a90a11b7	2023-12-20	Warnings	Exact identifier application number: M021
Orajel Complete Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	daebd16f-d278-446d-8b7a-33add5a74fdd	2023-12-19	Warnings	Exact identifier application number: M021
Orajel Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	Church & Dwight Co., Inc.	7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb	2023-12-19	Warnings	Exact identifier application number: M021
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier application number: M021
Beyond Activated Coconut Charcoal and Sea Salt	SODIUM FLUORIDE	Beyond International Inc	d075fa15-7309-0c10-e053-2995a90a7c95	2023-11-28	Warnings	Exact identifier application number: M021
Pro-Den Rx	STANNOUS FLUORIDE	Den-mat Holdings, Llc	9036aa8a-59b1-41b0-b3cb-529d3303a1c0	2023-11-20	Warnings	Exact identifier application number: M021
Fluoridex	STANNOUS FLUORIDE RINSE	DEN-MAT HOLDINGS, LLC	5e81f073-c0ca-aa38-e053-2a91aa0ab37b	2023-11-20	Warnings	Exact identifier application number: M021
Hello Vitamin C Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	38a0276e-910c-527d-1736-65928b9d4ca4	2023-11-20	Warnings	Exact identifier application number: M021
POP Feeling Peachy	SODIUM FLUORIDE	LG H&H CO., LTD.	0abaf99b-9547-46ae-e063-6394a90a6c15	2023-11-17	Warnings	Exact identifier application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	e3356374-befa-41b0-ab0f-edfd5a062601	2023-11-16	Warnings	Exact identifier application number: M021
ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	421fc2f0-b118-4e7a-a399-ba4780028c54	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Universal Distribution Center LLC	3411924d-1002-460c-83e8-c0c7fbff9ad1	2023-11-16	Warnings	Exact identifier application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e	2023-11-16	Warnings	Exact identifier application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Universal Distribution Center LLC	879dfaf0-27c8-41a3-8d01-a1c3eec9edfc	2023-11-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	0989936c-237d-dc63-e063-6294a90a885f	2023-11-07	Warnings	Exact identifier application number: M021
Eurofresh Whitening	SODIUM FLUORIDE	Farmasi US LLC	b56b2b55-e3a4-785a-e053-2a95a90a7abf	2023-11-05	Warnings	Exact identifier application number: M021
Farmasi Whitening	SODIUM FLUORIDE	Farmasi US LLC	25b3608e-abed-41ca-9971-21981b8a4610	2023-11-05	Warnings	Exact identifier application number: M021
United Airlines Therabody UPP Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	fb6c355b-a67d-c4b4-e053-6394a90a0e66	2023-10-26	Warnings	Exact identifier application number: M021
United Dental Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	7f348fe7-9918-4934-bed0-f0a77c09d046	2023-10-26	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