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 |
|---|---|---|---|---|---|---|
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bc66bc1b-c0d5-2481-e053-2a95a90a75de | 2025-12-04 | Warnings | M017 |
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bafd199a-e198-d5d1-e053-2995a90ad1cb | 2025-12-04 | Warnings | M017 |
| AleveX | CAMPHOR AND MENTHOL | Bayer HealthCare LLC | bafdf06b-25f5-e29e-e053-2a95a90a5e1b | 2025-12-04 | Warnings | M017 |
| Milagroso | METHYL SALICYLATE | Pharmadel LLC | fdcc8f44-afa0-3af0-e053-6394a90aa46d | 2025-12-04 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35221a-2fcb-2735-e063-6294a90a88ca | 2025-12-04 | Warnings | M017 |
| Pain Relieving | TROLAMINE SALICYLATE | CARDINAL HEALTH 110, LLC. DBA LEADER | b813262e-57c6-4d2c-8cc0-7a17f6f59343 | 2025-12-04 | Warnings | M017 |
| Gold Bond Medicated Extra Strength Body | MENTHOL | Gold Bond Co LLC | 7b75b7de-9c0b-4edf-b923-320f7d2bb1e6 | 2025-12-04 | Warnings | M017 |
| Lidocaine Patch | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 38767081-7011-6602-e063-6394a90a2784 | 2025-12-03 | Warnings | M017 |
| 4% Lidocaine Maximum Strength Pain Relief | LIDOCAINE | Shenzhen Finona Information Technology Co., Ltd | 3e5a5165-a773-0501-e063-6294a90ae2f4 | 2025-12-03 | Warnings | M017 |
| Leader Lidocaine | LIDOCAINE HCL | CARDINAL HEALTH | cece6765-0e2f-5ce9-e053-2995a90a3758 | 2025-12-03 | Warnings | M017 |
| Westlake Lidocaine | LIDOCAINE HCL | Westlake Pharma LLC | 0c586a14-1a2a-9f42-e063-6294a90a16c1 | 2025-12-03 | Warnings | M017 |
| CVS Lidocaine Maximum Strength | LIDOCAINE HCL | CVS Pharmacy | 87490c0f-a4d9-740e-e053-2a95a90a4724 | 2025-12-03 | Warnings | M017 |
| CVS Maximum Strength Burn | LIDOCAINE HYDROCHLORIDE 4% | CVS Pharmacy | 4510f379-c5a4-92c3-e063-6294a90a0a32 | 2025-12-03 | Warnings | M017 |
| LidoPatch Pain Relief | LIDOCAINE, MENTHOL | JAR Laboratories | 07289aa1-43ed-df31-e063-6394a90a764a | 2025-12-03 | Warnings | M017 |
| Equate Pain Relief Cream | 4% LIDOCAINE HCL | Walmart, Inc | 7d8e8a9a-5474-4c7b-e053-2991aa0a29f5 | 2025-12-03 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 14f23c28-c713-4868-9f46-66363bf94b2c | 2025-12-03 | Warnings | M017 |
| ElixirCortiRelief | HYDROCORTISONE | ELIXIR HEALTHCARE USA, LLC. | a6ca66f3-9759-4c98-a758-45700bc08352 | 2025-12-02 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Trifecta Pharmaceuticals USA, LLC. | 12a27ce7-c547-7134-e063-6394a90a94bd | 2025-12-02 | Warnings | M017 |
| 5Kind DMSO | MENTHOL, METHYL SALICYLATE | 5KIND TRADING LTD | 6a6c7241-f544-4784-9581-f5b172fdbec7 | 2025-12-02 | Warnings | M017 |
| PEDIADERMICS ECZEMA 2 | HYDROCORTISONE | RENU LABORATORIES, LLC | da840bf6-ed65-bafc-e053-2a95a90a92d5 | 2025-12-02 | 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 |