SBS 40

Product NDC
11084-040
11-digit product format
110840040
Labeler code
11084
Product ID
11084-040_a6650b96-9a5e-43e6-8bd4-a8d6d4c74815
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
LOTION
Route
TOPICAL
Labeler
Deb USA, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
ALLANTOIN
Active strength
1 mL/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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11084-040-082019-10-21C16284748780-1956f9ecf-c183-621f-e053-dbdaa90a74adDrug Facts
11084-040-352019-10-21C16284748780-1956f9ecf-c183-621f-e053-dbdaa90a74adDrug Facts
11084-040-392019-10-21C16284748780-1956f9ecf-c183-621f-e053-dbdaa90a74adDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11084-040-08SBS 402500 mL in 1 BOTTLE, PLASTICLOTION25001
11084-040-35SBS 40148 mL in 1 TUBELOTION1481
11084-040-39SBS 4030 mL in 1 TUBELOTION301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllantoinACTIVE INGREDIENT344S277G0ZSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
AllantoinACTIVE MOIETY344S277G0ZSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
Carbomer 934INACTIVE INGREDIENTZ135WT9208SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
Cetyl Esters WaxINACTIVE INGREDIENTD072FFP9GUSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
ChloroxylenolINACTIVE INGREDIENT0F32U78V2QSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
LanolinINACTIVE INGREDIENT7EV65EAW6HSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9USBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RSBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11084-040SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]1Legacy NDC, 3 package rows20100908_52b86b15-5df4-4042-ac2b-b96fbd3db0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087954allantoin 0.5 % Topical LotionPSN52b86b15-5df4-4042-ac2b-b96fbd3db0a71
1087954allantoin 5 MG/ML Topical LotionSCD52b86b15-5df4-4042-ac2b-b96fbd3db0a71
1087954allantoin 0.5 % Topical LotionSY52b86b15-5df4-4042-ac2b-b96fbd3db0a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11084-040-08110840040082500 mL in 1 BOTTLE, PLASTIC2500 mlHistorical
11084-040-3511084004035148 mL in 1 TUBE148 mlHistorical
11084-040-391108400403930 mL in 1 TUBE30 mlHistorical