Colgate

Product NDC: 69491-060
11-digit product format: 694910060
Labeler code: 69491
Product ID: 69491-060_d421cf44-3065-b927-e053-2995a90ae1b7
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE
Route: DENTAL
Labeler: Buzz Export Services Pty., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-12-03
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 2 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69491-060		I	Inactivated by FDA	2026-10-05
excluded package	package	69491-060	69491-060-45	I	Inactivated by FDA	2026-10-05
excluded package	package	69491-060	69491-060-94	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 · 45 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	69491-060-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69491-060-94	`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	69491-060-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69491-060-94	`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	69491-060-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69491-060-94	`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	69491-060-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69491-060-94	`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	69491-060-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69491-060-94	`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	69491-060-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69491-060-94	`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	69491-060-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69491-060-94	`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	69491-060-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69491-060-94	`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	69491-060-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69491-060-94	`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	69491-060-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69491-060-94	`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	69491-060-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69491-060-94	`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	69491-060-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69491-060-94	`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	69491-060-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69491-060-94	`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	69491-060-45	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69491-060-94	`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	69491-060-45	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69491-060-94	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69491-060-45	2023-01-30	DENTAL KITS - COLGATE TOOTHPASTE
69491-060-94	2023-01-30	DENTAL KITS - COLGATE TOOTHPASTE
69491-060-45	2020-03-04	DENTAL KITS - COLGATE TOOTHPASTE
69491-060-94	2020-03-04	DENTAL KITS - COLGATE TOOTHPASTE
69491-060-45	2020-01-31	DENTAL KITS - COLGATE TOOTHPASTE
69491-060-94	2020-01-31	DENTAL KITS - COLGATE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69491-060-45	Colgate	1 in 1 BAG	PASTE	1	6
69491-060-45	Colgate	5 g in 1 TUBE	PASTE	5	6
69491-060-94	Colgate	1 in 1 CARTON	PASTE	1	6
69491-060-94	Colgate	10 g in 1 TUBE	PASTE	10	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD. ]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69491-060	COLGATE (SODIUM FLUORIDE) PASTE [BUZZ EXPORT SERVICES PTY., LTD.]	6	Legacy NDC, 4 package rows	20211228_f84217da-dc78-4181-9fcc-6b11e92276ff.zip
69491-060	DELTA SKY CLUB (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD]	3	Legacy NDC	20211228_6e20c627-b72a-0bdb-e053-2a91aa0ae5db.zip
69491-060	UNITED AIRLINES POLARIS KIT WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD (BUZZ PRODUCTS)]	2	Legacy NDC	20231221_de4564a4-1012-baad-e053-2a95a90a11b7.zip
69491-060	UNITED AIRLINES UPP KIT WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD (BUZZ PRODUCTS)]	2	Legacy NDC	20231221_de4555d0-cc45-8446-e053-2a95a90a7d90.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
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	f84217da-dc78-4181-9fcc-6b11e92276ff	6
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	de4564a4-1012-baad-e053-2a95a90a11b7	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	de4564a4-1012-baad-e053-2a95a90a11b7	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	de4564a4-1012-baad-e053-2a95a90a11b7	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	de4564a4-1012-baad-e053-2a95a90a11b7	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	de4564a4-1012-baad-e053-2a95a90a11b7	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	de4564a4-1012-baad-e053-2a95a90a11b7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69491-060-45	69491006045	1 TUBE in 1 BAG (69491-060-45) > 5 g in 1 TUBE	1 tube	2014-12-03	0000-00-00	No	No	Current
69491-060-94	69491006094	1 TUBE in 1 CARTON (69491-060-94) > 10 g in 1 TUBE	1 tube	2014-12-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
United Airlines UPP Kit with Colgate	Buzz Export Services Pty Ltd (Buzz Products)	2023-12-21	HUMAN OTC DRUG LABEL	2
United Airlines Polaris Kit with Colgate	Buzz Export Services Pty Ltd (Buzz Products)	2023-12-20	HUMAN OTC DRUG LABEL	2
United Airlines Transcon Kit with Colgate	Buzz Export Services Pty Ltd (Buzz Products)	2023-12-20	HUMAN OTC DRUG LABEL	2
DENTAL KITS - COLGATE TOOTHPASTE	Buzz Export Services Pty., Ltd. \| Zhejiang Baron Travel Product Co., Ltd.	2021-12-27	HUMAN OTC DRUG LABEL	6
Delta Sky Club Dental Kit	Buzz Export Services Pty Ltd	2021-12-27	HUMAN OTC DRUG LABEL	3