dawnmist

Product NDC
55504-4341
11-digit product format
555044341
Labeler code
55504
Product ID
55504-4341_87b9b288-0dd8-4b02-90b2-bb09ab8838c6
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Donavan
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
40 g/181.4g
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 productproduct55504-4341IInactivated by FDA2026-08-17
excluded packagepackage55504-434155504-4341-8IInactivated by FDA2026-08-17

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 packagepackage55504-4341-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55504-4341-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55504-4341-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55504-4341-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55504-4341-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55504-4341-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55504-4341-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55504-4341-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55504-4341-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55504-4341-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55504-4341-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55504-4341-8557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55504-4341-88af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55504-4341-8834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55504-4341-81332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55504-4341-8fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55504-4341-886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55504-4341-8bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55504-4341-88dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55504-4341-8e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55504-4341-89bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55504-4341-8110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55504-4341-82019-11-13C16284748780-197449f38-d2a1-f6ea-e053-dbdaa90aa703Dawnmist toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55504-4341-8dawnmist181.4 g in 1 TUBEPASTE181.44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W7DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
fluoride ionACTIVE MOIETYQ80VPU408ODAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0ZDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SODIUM FLUORIDEINACTIVE INGREDIENT8ZYQ1474W7DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
SORBITOLINACTIVE INGREDIENT506T60A25RDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4
WATERINACTIVE INGREDIENT059QF0KO0RDAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55504-4341DAWNMIST (SODIUM FLUORIDE) PASTE [DONAVAN]4Legacy NDC, 1 package rows20120124_638050f5-3f08-4352-85d8-d4291d0d6237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN638050f5-3f08-4352-85d8-d4291d0d62374
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD638050f5-3f08-4352-85d8-d4291d0d62374
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY638050f5-3f08-4352-85d8-d4291d0d62374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55504-4341-855504434108181.4 g in 1 TUBE181.4 gHistorical