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 47 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL JC SALES 490bc3b1-48bf-5437-e063-6394a90a9018 2026-01-01 Warnings Exact identifier application number: M017 NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5ae00308-0a8c-065c-e063-6394a90aff6b 2026-01-01 Warnings Exact identifier application number: M017 NUVALU ICE THERAPY MENTHOL PAIN RELIEVING MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 4a24e813-6dbc-3fd1-e063-6294a90a4ff0 2026-01-01 Warnings Exact identifier application number: M017 Lidozen Patch LIDOCAINE, MENTHOL Village Pharma LLC d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6 2026-01-01 Warnings Exact identifier application number: M017 FEMININE PAIN RELIEF MENTHOL, UNSPECIFIED FORM BeYou Together Ltd 9636b973-fe7e-481e-a6e9-8070347c0883 2025-12-31 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL FSA Store Inc. 47434af6-0fdd-9615-e063-6394a90ab9e8 2025-12-31 Warnings Exact identifier application number: M017 Winco Lidocaine Pain Patch 4% 5ct LIDOCAINE PAIN PATCH 4% WINCO FOODS, LLC 47439162-fc34-f0d0-e063-6394a90a29ab 2025-12-31 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH QUEST USA CORP. 1ad47834-4f8e-c692-e063-6294a90a7e77 2025-12-31 Warnings Exact identifier application number: M017 Dermagesic PRAMOXINE HCL, ZINC OXIDE, CALAMINE Llorens Pharmaceutical International Division bbff6b53-29da-45c1-8ccd-3e9df7f250e0 2025-12-31 Warnings Exact identifier application number: M017 Dologesic Roll-On LIDOCAINE HCL Llorens Pharmaceutical International Division, Inc. 81546810-85a8-45fe-b9e6-cdd02cc4c080 2025-12-31 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Lavender CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 47473b24-a3e3-2858-e063-6394a90a5920 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Itch Relief Intensive Calming MENTHOL Beiersdorf Inc a7a78af1-1f5a-684d-e053-2a95a90a6ae9 2025-12-31 Warnings Exact identifier application number: M017 Eucerin Skin Calming Itch Relief Treatment MENTHOL Beiersdorf Inc 7e568311-1e6b-9b4b-e053-2991aa0a7b67 2025-12-31 Warnings Exact identifier application number: M017 Steady Freddy LIDOCAINE Medical Symbiosis Pty Ltd caa9eae9-7028-5185-e053-2a95a90ac504 2025-12-31 Warnings Exact identifier application number: M017 HYDROCORTISONE ANTI-ITCH CREAM Water-Jel Technologies 3d34ae31-265a-46bc-a52d-546ea5bb24b6 2025-12-31 Warnings Exact identifier application number: M017 Antibacterial Lidocaine Wound Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Water-Jel Technologies, LLC ef1a6100-7f78-1fdb-e053-2a95a90abf20 2025-12-31 Warnings Exact identifier application number: M017 Kroger Pain Relief Lidocaine Patch LIDOCAINE Kroger Company f6407554-c9a7-24e2-e053-2a95a90aae02 2025-12-30 Warnings Exact identifier application number: M017 Kroger Hot and Cold Medicated Patch MENTHOL Kroger Company 0331c1dd-fe30-421a-85a7-6c6886e7ab27 2025-12-30 Warnings Exact identifier application number: M017 Menthol, Camphor MENTHOL, CAMPHOR Chemco Corporation 472fb097-92e5-c230-e063-6294a90ab33a 2025-12-30 Warnings Exact identifier application number: M017 MENTHOL MENTHOL CHEMCO CORPORATIOM 472fb99c-dcc2-d9a9-e063-6294a90a794c 2025-12-30 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