Dibucaine

Product NDC
57896-131
11-digit product format
578960131
Labeler code
57896
Product ID
57896-131_29b472b9-6743-2403-e063-6294a90a22d0
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine 1%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-22
Substance
DIBUCAINE
Active strength
1 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dibucaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIBUCAINE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6JW2TJG99
Rxcui238784

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-131-01Dibucaine28 g in 1 TUBEOINTMENT284
57896-131-01Dibucaine1 in 1 BOXOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-131-01GM - Gram57896-1314a04f944-b7c2-4d7f-89f2-4e034d961b0812021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-131DIBUCAINE (DIBUCAINE 1%) OINTMENT [GERI-CARE PHARMACEUTICALS, CORP]4Current NDC, Legacy NDC, 2 package rows20241222_afe88610-5cac-960e-e053-2a95a90a7ba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238784dibucaine 1 % Rectal OintmentPSNafe88610-5cac-960e-e053-2a95a90a7ba44
238784dibucaine 0.01 MG/MG Rectal OintmentSCDafe88610-5cac-960e-e053-2a95a90a7ba44
238784dibucaine 1 % Rectal OintmentSYafe88610-5cac-960e-e053-2a95a90a7ba44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-131-01578960131011 TUBE in 1 BOX (57896-131-01) / 28 g in 1 TUBE1 tube2020-09-220000-00-00NoNoCurrent