DENBLAN

Product NDC
16555-996
11-digit product format
165550996
Labeler code
16555
Product ID
16555-996_3771b213-03f0-45e5-9423-bff016c95c56
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
DARPHIN DIST.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-08-01
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mL/100mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16555-996IInactivated by FDA2026-08-10
excluded packagepackage16555-99616555-996-01IInactivated by FDA2026-08-10

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 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 packagepackage16555-996-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16555-996-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16555-996-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16555-996-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16555-996-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16555-996-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16555-996-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16555-996-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16555-996-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16555-996-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16555-996-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16555-996-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16555-996-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16555-996-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16555-996-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16555-996-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16555-996-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16555-996-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage16555-996-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16555-996-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16555-996-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16555-996-01110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16555-996-012019-11-13C16284748780-197449f38-b672-f6ea-e053-dbdaa90aa703WHITENING FORMULA DENBLAN ANTICAVITY FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16555-996-01DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE1 in 1 CARTONPASTE, DENTIFRICE11
16555-996-01DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE75 mL in 1 TUBEPASTE, DENTIFRICE751

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408ODENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
ANGELICA ROOT OILINACTIVE INGREDIENTB25G881UOXDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
FENNEL OILINACTIVE INGREDIENT59AAO5F6HTDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
MENTHA ARVENSIS LEAF OILINACTIVE INGREDIENT1AEY1M553NDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
PAPAYAINACTIVE INGREDIENTKU94FIY6JBDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
PARSLEY SEED OILINACTIVE INGREDIENTXB8Q500O0ZDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081ODENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
SPEARMINT OILINACTIVE INGREDIENTC3M81465G5DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
USNEA BARBATAINACTIVE INGREDIENTD6DVA9TCAPDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1
WATERINACTIVE INGREDIENT059QF0KO0RDENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16555-996DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DARPHIN DIST.]1Legacy NDC, 2 package rows20120127_dbd98251-c137-4066-9645-f8b8ca71de16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNdbd98251-c137-4066-9645-f8b8ca71de161
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDdbd98251-c137-4066-9645-f8b8ca71de161
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYdbd98251-c137-4066-9645-f8b8ca71de161
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYdbd98251-c137-4066-9645-f8b8ca71de161
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYdbd98251-c137-4066-9645-f8b8ca71de161
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYdbd98251-c137-4066-9645-f8b8ca71de161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16555-996-01165550996011 in 1 CARTONHistorical