Home NDC 69396-023 Dibucaine
Product NDC 69396-023
11-digit product format 693960023
Labeler code 69396
Product ID 69396-023_0df7b6dd-a4d8-c9a6-e063-6394a90a0f52
Type HUMAN OTC DRUG
Nonproprietary name Dibucaine 1%
Dosage form OINTMENT
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-14
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dibucaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIBUCAINE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L6JW2TJG99 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69396-023-01 Dibucaine 28.4 g in 1 TUBE OINTMENT 28.4 2 69396-023-01 Dibucaine 1 in 1 BOX OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-023 DIBUCAINE (DIBUCAINE 1%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240103_e8a56651-a292-7609-e053-2a95a90a7c36.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 40 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Relief Gel DIPHENHYDRAMINE HCL Walgreens 487060a7-dff3-4840-b967-ca919f8d0a29 2026-01-15 Warnings Exact identifier application number: M017 Walgreen Itch Relief Gel DIPHENHYDRAMINE HYDROCHLORIDE Walgreens 5aca3297-406f-4165-9895-c58ccffb374f 2026-01-15 Warnings Exact identifier application number: M017 Pain Relieving Patch LIDOCAINE FlexiGo Inc. 4868af2a-c4be-9c68-e063-6394a90a565b 2026-01-15 Warnings Exact identifier application number: M017 Helocaine Cold Sore Fever Blister Treatment TETRACAINE, MINERAL Pagari Life Science Corp. 1b2eae09-5de0-9219-e063-6294a90af046 2026-01-15 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6ca8382-7ce5-4df9-912e-8a0ac0423116 2026-01-15 Warnings Exact identifier application number: M017 Neuropathy Cream MENTHOL CREAM Owell Naturals Brand, LLC 48739205-627b-41d0-e063-6394a90a3462 2026-01-15 Warnings Exact identifier application number: M017 BLT 1 BENZOCAINE CENTURA PHARMACEUTICALS INC 3eea2171-850b-4045-e054-00144ff8d46c 2026-01-15 Warnings Exact identifier application number: M017 Icy Hot Lidocaine Dry LIDOCAINE, MENTHOL Chattem, Inc. d500a74e-ab93-4919-8665-a89e9d4cad28 2026-01-15 Warnings Exact identifier application number: M017 Cortizone 10 Bug Bite Relief 1% HYDROCORTISONE Chattem, Inc. b21b6c04-8246-4567-98cf-64e8c588e79c 2026-01-15 Warnings Exact identifier application number: M017 Gold Bond Intensive Relief Anti-Itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chattem, Inc. e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8 2026-01-14 Warnings Exact identifier application number: M017 Cortizone-10 Soothing Aloe Creme HYDROCORTISONE Chattem, Inc. 1a841bf0-9d7b-4566-b442-aa9bcc827846 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Sensitive Skin Creme HYDROCORTISONE Chattem, Inc. b139917c-00bb-4cb3-995d-a6d2f2c295c6 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 for Psoriasis HYDROCORTIZONE Chattem, Inc. fad9eedb-95e1-4e1a-91e5-0bfd077e0cf5 2026-01-14 Warnings Exact identifier application number: M017 Pain Relief Roll On TOPICAL ANALGESIC Eagle Labs Inc 2380a400-062a-4a8d-a594-a2e097219044 2026-01-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE 4% AvKARE 70aace2f-47b4-e961-e053-2991aa0a6367 2026-01-14 Warnings Exact identifier application number: M017 JUST CBD - ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC 485f355a-4458-67b6-e063-6394a90ab2a0 2026-01-14 Warnings Exact identifier application number: M017 Relief Pain Relieving Cream MENTHOL Corganics, LP 85814fff-35f8-447f-b669-87eaf55e9859 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Cherry CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 486269c9-af3a-7856-e063-6294a90a378c 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Vapor Max CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 4863606f-f7c8-b4a4-e063-6294a90a1138 2026-01-14 Warnings Exact identifier application number: M017 Hydrocortisone Cream Intensive Healing HYDROCORTISONE CREAM Walgreens 8a3f486c-1353-466d-9ea7-c14559b53bf3 2026-01-14 Warnings Exact identifier application number: M017
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 69396-023-01 69396002301 1 TUBE in 1 BOX (69396-023-01) / 28.4 g in 1 TUBE 1 tube 2022-09-14 0000-00-00 No No Current