Dibucaine

Product NDC
63868-911
11-digit product format
638680911
Labeler code
63868
Product ID
63868-911_eb3fe0f7-035a-411d-e053-2a95a90a13e9
Type
HUMAN OTC DRUG
Nonproprietary name
Dibucaine 1%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-14
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-911-012025-01-30C16284748780-12cef2736-99cd-d83d-e063-dadaa90ab31fQuality Choice Dibucaine Ointment 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-911-01Dibucaine1 in 1 BOXOINTMENT12
63868-911-01Dibucaine28.3 g in 1 TUBEOINTMENT28.32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-911-01GM - Gram63868-911454b140f-a537-487e-b5ef-e5dd3a3049ed12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-911DIBUCAINE (DIBUCAINE 1%) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 2 package rows20230525_eb3fe8ef-5d98-7787-e053-2a95a90ad8b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238784dibucaine 1 % Rectal OintmentPSNeb3fe8ef-5d98-7787-e053-2a95a90ad8b22
238784dibucaine 0.01 MG/MG Rectal OintmentSCDeb3fe8ef-5d98-7787-e053-2a95a90ad8b22
238784dibucaine 1 % Rectal OintmentSYeb3fe8ef-5d98-7787-e053-2a95a90ad8b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-911-01638680911011 TUBE in 1 BOX (63868-911-01) > 28.3 g in 1 TUBE1 tube2022-09-140000-00-00NoNoCurrent