SBS 40

Product NDC
11084-240
11-digit product format
110840240
Labeler code
11084
Product ID
11084-240_d12f476d-35fd-4e9b-a4d7-ad5d26c98b90
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Deb USA, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
5 mg/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11084-240-082020-01-31C16284748780-19d75b9d0-55c9-f424-e053-dadaa90a57ceSBS 40
11084-240-352020-01-31C16284748780-19d75b9d0-55c9-f424-e053-dadaa90a57ceSBS 40
11084-240-392020-01-31C16284748780-19d75b9d0-55c9-f424-e053-dadaa90a57ceSBS 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-240-08SBS 402500 mL in 1 BOTTLECREAM250010
11084-240-35SBS 40148 mL in 1 TUBECREAM14810
11084-240-39SBS 4030 mL in 1 TUBECREAM3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
ALLANTOINACTIVE MOIETY344S277G0ZSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
CARBOMER 934INACTIVE INGREDIENTZ135WT9208SBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
LANOLININACTIVE INGREDIENT7EV65EAW6HSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
TRIETHANOLAMINE BENZOATEINACTIVE INGREDIENTM3EN4GC19WSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RSBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-240SBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]10Legacy NDC, 3 package rows20170215_08e8ecd8-1ea0-4d84-9790-55d73bf0eb07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241509allantoin 0.5 % Topical CreamPSN08e8ecd8-1ea0-4d84-9790-55d73bf0eb0710
241509allantoin 5 MG/ML Topical CreamSCD08e8ecd8-1ea0-4d84-9790-55d73bf0eb0710
241509allantoin 0.5 % Topical CreamSY08e8ecd8-1ea0-4d84-9790-55d73bf0eb0710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11084-240-08110840240082500 mL in 1 BOTTLE2500 mlHistorical
11084-240-3511084024035148 mL in 1 TUBE148 mlHistorical
11084-240-391108402403930 mL in 1 TUBE30 mlHistorical