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 |
|---|---|
| DIBUCAINE | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L6JW2TJG99 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 238784 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8a56651-a292-7609-e053-2a95a90a7c36 | Available on FDA.report |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LidoReal Patch | LIDOCAINE AND MENTHOL | FORREAL PHARMACEUTICALS LLC | 19f1c037-b4b8-47b0-b0f9-036691c1d307 | 2024-07-05 | Warnings | M017 |
| Lip Medex Lip Balm | PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL | Blistex Inc. | 988f97e8-a59f-4bc0-9d71-60607364a686 | 2024-07-01 | Warnings | M017 |
| Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM | MENTHOL | L'Oreal USA Products Inc | d580982f-dda6-4b03-bf84-342b9f2c6d93 | 2024-06-29 | Warnings | M017 |
| Lip Medex Cherry | PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8 | 2024-06-28 | Warnings | M017 |
| 10% Methyl Salicylate Pain Relief Patch | 10% METHYL SALICYLATE | Akron Coating & Adhesives | 1be1f1ce-3238-a8ed-e063-6294a90a5aed | 2024-06-27 | M017 | |
| Genuine First Aid Alcohol Cleansing Pad | BENZOCAINE, ALCOHOL | GFA Production (Xiamen) Co., Ltd. | c39c4d80-9718-459f-8ae4-ada043bba5b7 | 2024-06-26 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bd5cf69-9a08-5e2e-e063-6394a90a03cd | 2024-06-26 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 2c0389db-ceb2-422b-9575-bdb8fe649a1e | 2024-06-26 | Warnings | M017 |
| astonea | HYDROCORTISONE | ASTONEA LABS PRIVATE LIMITED | de09e859-c5fd-0cc5-e053-2a95a90a147e | 2024-06-25 | Warnings | M017 |
| HealthWise Pain Relief Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 0190196d-5f78-042b-e063-6294a90a3714 | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bc1bf83-91ee-ec9d-e063-6394a90a3daf | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1bc2f688-d0c4-690e-e063-6294a90abc38 | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 1b9fdac0-9fb0-e669-e063-6394a90aece9 | 2024-06-24 | Warnings | M017 |
| Capsaicin | CAPSAICIN | Asclemed USA, Inc. | 97d506bd-3215-4e2e-9914-af1c174dd4ab | 2024-06-20 | Warnings | M017 |
| ABREVA Rapid Pain Relief | GLYCERIN, LIDOCAINE | Haleon US Holdings LLC | 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d | 2024-06-20 | Warnings | M017 |
| Frankie Avalons ZERO PAIN Roll-On Pain Reliever | CAPSAICIN | WHY ENTERPRISES LLC | e32acb5f-5bc3-4228-b037-6315d080f556 | 2024-06-17 | Warnings | M017 |
| PUREGEN LABS Pain Relief 4 Lidocaine | LIDOCAINE | Advanced Rx LLC | 9dff40d8-8d7e-4629-bea5-987f5e68477d | 2024-06-11 | Warnings | M017 |
| SMOOTH GATOR Head-Ezz Analgesic | MENTHOL | Smooth Gator LLC | 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd | 2024-06-10 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | Epic Medical Supply Corp | bd1b1873-e900-45eb-96a0-28f782b5a7cd | 2024-06-04 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | Chain Drug Marketing Association Inc. | 1c834ba0-86b6-8e61-e063-6394a90a192d | 2024-06-04 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238784 | dibucaine 1 % Rectal Ointment | PSN | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
| 238784 | dibucaine 0.01 MG/MG Rectal Ointment | SCD | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
| 238784 | dibucaine 1 % Rectal Ointment | SY | e8a56651-a292-7609-e053-2a95a90a7c36 | 2 |
Packages#
| 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 |