FDA.reportPublic FDA data

Sarene Soothing Skin

Product NDC
52319-001
11-digit product format
523190001
Labeler code
52319
Product ID
52319-001_a4520022-5845-44a8-aa30-bab7729af0d0
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
STICK
Route
TOPICAL
Labeler
Beekley Corporation
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-04-19
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
5 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52319-001-132019-10-21C16284748780-1956f9ecf-c4c5-621f-e053-dbdaa90a74adSarene Soothing Skin Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52319-001-13Sarene Soothing Skin1 in 1 BOXSTICK12
52319-001-13Sarene Soothing Skin36.9 g in 1 TUBESTICK36.92

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZSARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2
ALLANTOINACTIVE MOIETY344S277G0ZSARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0SARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52319-001SARENE SOOTHING SKIN (ALLANTOIN) STICK [BEEKLEY CORPORATION]2Legacy NDC, 2 package rows20100419_362ff4ef-e3e6-40a7-a654-3f3c49d1e3d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044541allantoin 0.5 % Topical OintmentPSN362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044545Sarene 0.5 % Topical StickPSN362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044545allantoin 0.005 MG/MG Topical Ointment [Sarene]SBD362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044541allantoin 0.005 MG/MG Topical OintmentSCD362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044541allantoin 0.5 % Topical StickSY362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044545Sarene 0.005 MG/MG Topical OintmentSY362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82
1044545Sarene 0.5 % Topical StickSY362ff4ef-e3e6-40a7-a654-3f3c49d1e3d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52319-001-13523190001131 in 1 BOXHistorical