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 |
|---|---|---|---|---|---|---|
| OWELL NATURALS NEUROPATHY MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL 8 LLC | 56b8d0cc-2f35-7d38-e063-6294a90ad06d | 2026-07-16 | Warnings | M017 |
| ANTIPHLAMINE | L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE | Masaem Company | 56b93c89-295b-f33a-e063-6294a90a5fe4 | 2026-07-16 | Warnings | M017 |
| Meriwether Skin Pain Relief | MENTHOL, UNSPECIFIED FORM | Meriwether Skin LLC | f6e155be-5879-4176-bb0e-e364f2e5cdf9 | 2026-07-16 | Warnings | M017 |
| Medi-First Muscle Rub Cream | MENTHOL, METHYL SALICYLATE | Unifirst First Aid Corporation | 56a6b8b2-7ab0-9854-e063-6294a90ab5ba | 2026-07-15 | Warnings | M017 |
| Painsil Pain Relief Roll-On | LIDOCAINE HYDROCHLORIDE | Painsil LLC | dee39dff-5749-4ef2-a9ed-182f25e01f67 | 2026-07-14 | Warnings | M017 |
| VARICOSE VEINS MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL & LLC | 5692914f-1b14-e3e3-e063-6394a90a94bf | 2026-07-14 | Warnings | M017 |
| ZyloRelief | LIDOCAINE HYDROCHLORIDE | Highmark Pharma LLC | 635f5b98-f74c-495f-a537-686fcba9ccad | 2026-07-14 | Warnings | M017 |
| ENOKON PAIN RELIEF Spray. | PAIN RELIEF SPRAY. | Henan Enokon Medical Instrument Co., Ltd. | 5675ec21-b947-2206-e063-6294a90aa509 | 2026-07-12 | Warnings | M017 |
| Topcare Pain Relief Patch | PAIN RELIEF PATCH MEDICATED 5% MENTHOL | 76162 | 4f00d0b8-d2f4-843b-e063-6294a90a332b | 2026-07-12 | Warnings | M017 |
| Penetral Roll-on | CAPSAICIN 0.025% | PureTek Corporation | 56204c03-8b15-a8b5-e063-6394a90a8189 | 2026-07-10 | Warnings | M017 |
| Intensive Healing Itch Relief | ITCH RELIEF CREAM | NeilMed Pharmaceuticals Inc | 563ef1d5-2180-bc45-e063-6294a90a813d | 2026-07-10 | Warnings | M017 |
| AVON Foot Works Arthritis Achy Foot and Muscle | METHYL SALICYLATE | COSMAX USA, CORPORATION | 56440d3f-bc93-cebb-e063-6294a90a5f79 | 2026-07-10 | Warnings | M017 |
| CHEONG KUN PAIN RELIEVING | CAMPHOR | CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED | 557d5cb3-2a05-4f45-e063-6394a90a9b12 | 2026-07-10 | Warnings | M017 |
| Biofreeze Professional | MENTHOL | Reckitt Benckiser LLC | 485c8208-c93b-5b84-e063-6394a90ab77a | 2026-07-10 | Warnings | M017 |
| Fit Mist Pain Relief | MENTHOL | Aroma Sensations Inc | f5a98544-8bd7-42dc-a594-5559e3920e29 | 2026-07-09 | Warnings | M017 |
| Nuturna Sciatica | MENTHOL | Micelle Laboratories, Incorporated | ff200864-bedf-4138-bdec-2b23701406dd | 2026-07-09 | Warnings | M017 |
| Lidocaine cream | DRS LIDOCAINE 5% CREAM | OL PHARMA TECH LLC. (Drs. Pharmacy) | 372fe018-1e5a-9ec4-e063-6294a90a1500 | 2026-07-09 | Warnings | M017 |
| Nupharmisto 4% Lidocaine Numbing cream | LIDOCAINE 4% | EveryMarket Inc | 5615e49d-e03b-f915-e063-6294a90a1786 | 2026-07-08 | Warnings | M017 |
| CAREALL Musle and Joint | MENTHOL | New World Imports, Inc | 561cc103-ae88-8f30-e063-6294a90a05c4 | 2026-07-08 | Warnings | M017 |
| HealthWise Medicated Cold Hot | MENTHOL | Veridian Healthcare, LLC | 561e1409-d1d8-e35d-e063-6394a90a4d8f | 2026-07-08 | 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 |