Colgate

Product NDC: 69491-060
Requested package NDC: 69491-060-45
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69491-060	69491-060-45	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (package): 69491-060-45 ndc11 (package): 69491006045

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

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