DELTA RON 2019 AMENITY With Colgate Cavity Protection

Product NDC: 69491-215
Requested package NDC: 69491-215-00
11-digit product format: 694910215
Labeler code: 69491
Product ID: 69491-215_d4228170-9c1e-49af-e053-2995a90a7983
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
Dosage form: KIT
Labeler: Buzz Export Services Pty., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-04-01
Marketing end: 0000-00-00
Active strength: 0
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	69491-215	69491-215-00	D	Discontinued by firm		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 · 12 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…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69491-215-00	2023-03-03	C162847	48780-1	f386c649-d5df-0266-e053-dadaa90a7c1a	DELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste
69491-215-00	2023-01-30	C162847	48780-1	f386c649-d5df-0266-e053-dadaa90a7c1a	DELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69491-215-00	69491021500	1 KIT in 1 KIT (69491-215-00) * 10 g in 1 TUBE (42555-060-45) * 14 g in 1 TUBE (64942-1343-2)	1 kit	2019-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste	Buzz Export Services Pty., Ltd.	2021-12-27	HUMAN OTC DRUG LABEL	4