Roota Re V Tonic

Product NDC
54576-4001
11-digit product format
545764001
Labeler code
54576
Product ID
54576-4001_85a5ce96-0229-4cff-928e-c422fbb37e0b
Type
HUMAN OTC DRUG
Nonproprietary name
PANTHENOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Raphabio Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-12-31
Marketing end
0000-00-00
Substance
PANTHENOL
Active strength
1 mg/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 productproduct54576-4001IInactivated by FDA2026-08-17
excluded packagepackage54576-400154576-4001-1IInactivated 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 packagepackage54576-4001-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54576-4001-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54576-4001-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54576-4001-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54576-4001-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54576-4001-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54576-4001-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54576-4001-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54576-4001-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54576-4001-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54576-4001-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54576-4001-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54576-4001-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54576-4001-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54576-4001-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54576-4001-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54576-4001-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54576-4001-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54576-4001-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54576-4001-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54576-4001-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54576-4001-1110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54576-4001-12019-11-27C16284748780-19855d018-ee5b-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54576-4001-1Roota Re V Tonic100 mL in 1 BOTTLE, WITH APPLICATORLIQUID1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTHENOLACTIVE INGREDIENTWV9CM0O67ZROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
PANTHENOLACTIVE MOIETYWV9CM0O67ZROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
ACORUS CALAMUS ROOTINACTIVE INGREDIENTXY1K7KIQ0FROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
FICUS CARICA WHOLEINACTIVE INGREDIENTMAW09HMQ3XROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
MORUS ALBA BARKINACTIVE INGREDIENT7O71A48NDPROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4ROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
ROSA CENTIFOLIA FLOWERINACTIVE INGREDIENTCS4TE8FF7OROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
SOPHORA FLAVESCENS ROOTINACTIVE INGREDIENTIYR6K8KQ5KROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5ROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
UREAINACTIVE INGREDIENT8W8T17847WROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1
WATERINACTIVE INGREDIENT059QF0KO0RROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54576-4001ROOTA RE V TONIC (PANTHENOL) LIQUID [RAPHABIO INC]1Legacy NDC, 1 package rows20130105_30a75e94-3964-4a42-a6e3-0de6ab290ce5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54576-4001-154576400101100 mL in 1 BOTTLE, WITH APPLICATOR100 mlHistorical