kolorz

Product NDC: 10733-372
11-digit product format: 107330372
Labeler code: 10733
Product ID: 10733-372_7d3a5132-76a6-4e74-bc5a-19607cecb30f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: AEROSOL, FOAM
Route: DENTAL
Labeler: Medical Products Laboratories, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2007-01-01
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 27 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10733-372		I	Inactivated by FDA		2026-10-05
excluded package	package	10733-372	10733-372-00	I	Inactivated by FDA		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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10733-372-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10733-372-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10733-372-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10733-372-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10733-372-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10733-372-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10733-372-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10733-372-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10733-372-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10733-372-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10733-372-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10733-372-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10733-372-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10733-372-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10733-372-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10733-372-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10733-372-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10733-372-00	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10733-372-00	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10733-372-00	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10733-372-00	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10733-372-00	`110d247fa046…`	`a55b01930146…`

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
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10733-372-00	2019-10-29	C162847	48780-1	960f7f55-caa3-8e05-e053-dbdaa90a074a	kolorz Sixty Second Fluoride Foam Blue Raspberry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10733-372-00	kolorz	6 in 1 BOX	AEROSOL, FOAM	6		1
10733-372-00	kolorz	125 g in 1 CAN	AEROSOL, FOAM	125		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
Fluoride ion	ACTIVE MOIETY	Q80VPU408O	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
BETAINE	INACTIVE INGREDIENT	3SCV180C9W	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10733-372	KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20110314_873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e.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
1093170	kolorz Sixty Second 2.72 % Oral Foam	PSN	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
248389	sodium fluoride 2.72 % Oral Foam	PSN	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
1093170	sodium fluoride 27.2 MG/ML Oral Foam [Kolorz]	SBD	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
248389	sodium fluoride 27.2 MG/ML Oral Foam	SCD	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
1093170	Kolorz 2.72 % Oral Foam	SY	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
1093170	Kolorz 27.2 MG/ML Oral Foam	SY	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
248389	sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Foam	SY	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1
248389	sodium fluoride 2.72 % Oral Foam	SY	873dd35e-ed1a-4f2b-bd7d-237f73ed8f8e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10733-372-00	10733037200	6 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
kolorz Sixty Second Fluoride Foam Blue Raspberry	Medical Products Laboratories, Inc.	2011-03-11	HUMAN PRESCRIPTION DRUG LABEL	1