RON 2

Product NDC
69491-030
11-digit product format
694910030
Labeler code
69491
Product ID
69491-030_d421f377-ef12-73c4-e053-2a95a90a8b0e
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
2015-03-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69491-030DDiscontinued by firm2026-10-05
excluded packagepackage69491-03069491-030-00DDiscontinued by firm2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69491-030-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69491-030-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69491-030-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69491-030-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69491-030-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69491-030-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69491-030-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69491-030-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69491-030-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69491-030-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69491-030-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69491-030-00557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69491-030-008af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69491-030-00834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69491-030-001332a3947898…d4bfe170f9cd…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-030-002023-01-30C16284748780-1f386c64a-3125-0266-e053-dadaa90a7c1aRON Kit 2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLYACTIVE INGREDIENT8O386558JERON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLYACTIVE MOIETY8O386558JERON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
FLUORIDE IONACTIVE MOIETYQ80VPU408ORON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311RON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ORON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7RON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
HYDROXYETHYL UREAINACTIVE INGREDIENTMBQ7DDQ7ARRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
PPG-14 BUTYL ETHERINACTIVE INGREDIENTR199TJT95TRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SORBITOLINACTIVE INGREDIENT506T60A25RRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
STEARETH-100INACTIVE INGREDIENT4OH5W9UM87RON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4
WATERINACTIVE INGREDIENT059QF0KO0RRON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-030RON 2 (SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) KIT [BUZZ EXPORT SERVICES PTY., LTD.]7Legacy NDC20211228_7430a8fb-9301-4449-bedc-8c8f21c43bb1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69491-030-00694910030001 KIT in 1 BAG (69491-030-00) * 14 g in 1 TUBE (64942-1343-3) * 10 g in 1 TUBE (42555-060-45) 1 kit2015-03-300000-00-00NoNoCurrent