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 128 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Meijer Cold Therapy Pain Relieving MENTHOL Meijer Inc 1c5b55e3-f859-71b6-e063-6294a90a633b 2024-08-08 Warnings Exact identifier application number: M017 HealthWise Soothing Cold Therapy Gel MENTHOL 4% Veridian Healthcare 1f09ccdd-09d8-6a8d-e063-6394a90a184f 2024-08-08 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. fbbbcc67-b46d-d41a-e053-6294a90aa55d 2024-08-08 Warnings Exact identifier application number: M017 Cheezheng Pain Relief Cream MENTHOL Tibet Cheezheng Tibetan Medicine Co. Ltd 37279a3f-9207-4e4c-90d6-52735044f104 2024-08-07 Warnings Exact identifier application number: M017 CVS Health Hydrocortisone Anti Itch HYDROCORTISONE CVS Health 546a1b8a-8254-432a-85c4-38ebee5ad568 2024-08-07 Warnings Exact identifier application number: M017 SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 Warnings Exact identifier application number: M017 Relief MENTHOL La Mend, Inc. 1f92de3a-7180-5884-e063-6294a90aebf5 2024-08-01 Warnings Exact identifier application number: M017 Meijer Medicated Foot Powder MENTHOL Meijer Distribution 07ec6c20-73c4-e5e4-e063-6294a90a7e55 2024-07-29 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. e05ec3b7-e9ab-4eaa-8518-86304336697c 2024-07-29 Warnings Exact identifier application number: M017 Walgreens Roll-On CAPSAISIN 0.1% Walgreens Co 1e65bf31-15c7-5e6a-e063-6394a90ac956 2024-07-29 Warnings Exact identifier application number: M017 Camphotrex CAMPHOR, MENTHOL PureTek Corporation 3b6c6eef-e92d-497d-afe8-82356637c2b8 2024-07-26 Warnings Exact identifier application number: M017 Camphotrol CAMPHOR, MENTHOL PureTek Corporation ccac9f37-a374-4765-e053-2a95a90ad2f7 2024-07-26 Warnings Exact identifier application number: M017 Real Time Pain Relief Foot MENTHOL Real Time Products Inc. 29c8e06d-9b29-44f9-ac21-9160d06475cb 2024-07-24 Warnings Exact identifier application number: M017 Capsaicin 0.075 Percent CAPSAICIN Alexso, Inc 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd 2024-07-22 Warnings Exact identifier application number: M017 TIDL Pain Relief CRYO Therapy Limited Edition PAIN RELIEF CRYO THERAPY LIMITED EDITION Shenzhen Sam Technology Co., Ltd. 1d966b67-fd9c-eab6-e063-6294a90aa75e 2024-07-19 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