FDA.reportPublic FDA data

Dibucaine

Product NDC
54162-011
11-digit product format
541620011
Labeler code
54162
Product ID
54162-011_80c8b75b-db66-4fc2-b666-7e1aa63a3b07
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GERITREX LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-31
Marketing end
0000-00-00
Substance
DIBUCAINE
Active strength
0 g/28g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-011-012020-01-31C16284748780-19d75b9d0-b929-f424-e053-dadaa90a57ceDibucaine Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-011-01Dibucaine28 g in 1 TUBEOINTMENT284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-011-01GM - Gram54162-011b3a3a889-28ad-4c5b-b87e-85c834fe32f612014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIBUCAINEACTIVE INGREDIENTL6JW2TJG99DIBUCAINE OINTMENT [GERITREX CORP]2
DIBUCAINEACTIVE MOIETYL6JW2TJG99DIBUCAINE OINTMENT [GERITREX CORP]2
ACETONE SODIUM BISULFITEINACTIVE INGREDIENT47VY054OXYDIBUCAINE OINTMENT [GERITREX CORP]2
LANOLININACTIVE INGREDIENT7EV65EAW6HDIBUCAINE OINTMENT [GERITREX CORP]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDIBUCAINE OINTMENT [GERITREX CORP]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDIBUCAINE OINTMENT [GERITREX CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RDIBUCAINE OINTMENT [GERITREX CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-011DIBUCAINE OINTMENT [GERITREX LLC]4Legacy NDC, 1 package rows20170825_fc11a231-1d2f-42ba-8ece-34495a14ab44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198601dibucaine 1 % Topical OintmentPSNfc11a231-1d2f-42ba-8ece-34495a14ab444
198601dibucaine 0.01 MG/MG Topical OintmentSCDfc11a231-1d2f-42ba-8ece-34495a14ab444
198601dibucaine 1 % Topical OintmentSYfc11a231-1d2f-42ba-8ece-34495a14ab444
198601dibucaine 1 GM per 100 GM Topical Ointment.SYfc11a231-1d2f-42ba-8ece-34495a14ab444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54162-011-015416200110128 g in 1 TUBE28 gHistorical