Home NDC 63868-911-01 Dibucaine
Product NDC 63868-911
Requested package NDC 63868-911-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-911-01 Dibucaine 1 in 1 BOX OINTMENT 1 2 63868-911-01 Dibucaine 28.3 g in 1 TUBE OINTMENT 28.3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-911 DIBUCAINE (DIBUCAINE 1%) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.] 2 Legacy NDC, 2 package rows 20230525_eb3fe8ef-5d98-7787-e053-2a95a90ad8b2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-911-01 63868091101 1 TUBE in 1 BOX (63868-911-01) > 28.3 g in 1 TUBE 1 tube 2022-09-14 0000-00-00 No No Current