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

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