Pine Salt

Product NDC
67510-0043
11-digit product format
675100043
Labeler code
67510
Product ID
67510-0043_feae241c-d9a2-4328-99bc-7a7e50e3b8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Kareway Product, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-22
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
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 productproduct67510-0043IInactivated by FDA2026-10-05
excluded packagepackage67510-004367510-0043-6IInactivated by FDA2026-10-05

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 · 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 packagepackage67510-0043-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0043-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0043-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0043-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0043-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0043-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0043-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0043-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0043-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0043-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67510-0043-6367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67510-0043-6557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67510-0043-68af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67510-0043-6834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67510-0043-61332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67510-0043-6fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67510-0043-686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67510-0043-6bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67510-0043-68dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67510-0043-6e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67510-0043-69bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67510-0043-6110d247fa046…a55b01930146…

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
67510-0043-62019-10-29C16284748780-1960f7f55-ca1c-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0043-6Pine Salt1 in 1 BOXPASTE, DENTIFRICE11
67510-0043-6Pine Salt170 g in 1 TUBEPASTE, DENTIFRICE1701

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
PEG-32 STEARATEINACTIVE INGREDIENT33GX5WQC0MPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
PINUS STROBUS BARKINACTIVE INGREDIENT8PJ4761097PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0043PINE SALT (SODIUM FLUORIDE) PASTE, DENTIFRICE [KAREWAY PRODUCT, INC.]1Legacy NDC, 2 package rows20110831_69fa139f-e50f-498f-9aea-a2bb2c5a52bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN69fa139f-e50f-498f-9aea-a2bb2c5a52bf1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD69fa139f-e50f-498f-9aea-a2bb2c5a52bf1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY69fa139f-e50f-498f-9aea-a2bb2c5a52bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67510-0043-6675100043061 in 1 BOXHistorical