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 |
|---|---|---|---|---|---|---|
| MyDerm Aloe and Lidocaine | LIDOCAINE | Medline Industries | fdfd4388-cd27-467b-959b-249a49ea5cf6 | 2026-05-26 | Warnings | M017 |
| MyDerm Aloe and Lidocaine | LIDOCAINE | Inspec Solutions LLC. | 4939c663-a876-4527-822a-df02964fa694 | 2026-05-26 | Warnings | M017 |
| Lidocaine Menthol Pain Relief | LIDOCAINE, MENTHOL | Amerisource Bergen | 94039190-dde3-4d8e-873a-79abd3f6208b | 2026-05-26 | Warnings | M017 |
| topcare hydrocortisone | HYDROCORTISONE | Topco Associates LLC | 858053a0-d888-4bb9-b94e-503bcf3864cb | 2026-05-21 | Warnings | M017 |
| Arthritis Pain Relief Cream | HISTAMINE DIHYDROCHLORIDE | Sombra Cosmetics Inc. | 523333ee-eccd-bcf7-e063-6394a90aea60 | 2026-05-21 | Warnings | M017 |
| North Star Nutritionals Soothanol X3 Pain Relieving Drops | MENTHOL | NEWMARKET HEALTH PRODUCTS, LLC | 068343b8-0435-40d0-846c-9d8624e8b6c4 | 2026-05-21 | Warnings | M017 |
| DO ME DELAY | LIDOCAINE HCL | Prodigy Media Inc | 5255ee85-6f29-0776-e063-6394a90a525b | 2026-05-21 | Warnings | M017 |
| Australian Dream Back Pain | HISTAMINE DIHYDROCHLORIDE | Sombra Cosmetics Inc. | 5256a63e-e6da-84c1-e063-6294a90a8dff | 2026-05-21 | Warnings | M017 |
| SINSIN HANBANG FLEX | CAMPHOR, MENTHOL | Sinsin Pharmaceutical co., ltd. | 525c5d18-bfc1-3002-e063-6394a90a5b1d | 2026-05-21 | Warnings | M017 |
| LidoPro Patch | LIDOCAINE, MENTHOL, AND METHYL SALICYLATE | Preferred Pharmaceuticals Inc. | 6c9a076e-6316-427b-9ce6-c8fe2d388837 | 2026-05-21 | Warnings | M017 |
| Medi-First Capsaicin Cream | CAPSAICIN | Unifirst First Aid Corporation | 49eb807b-fa31-3d84-e063-6394a90acfcf | 2026-05-20 | Warnings | M017 |
| Biofreeze Triple Target Roll-On | CAMPHOR, CAPSAICIN, MENTHOL | Reckitt Benckiser LLC | 5089c088-3026-233a-e063-6394a90a93b6 | 2026-05-19 | Warnings | M017 |
| Lidocaine Pain Relief Patch | LIDOCAINE | GERI-CARE PHARMACEUTICAL CORP | 522f1521-f9f2-4c26-e063-6394a90a9e05 | 2026-05-19 | Warnings | M017 |
| Easment 0.1% Capsaicin Roll on | CAPSAICIN 0.1% | Easment LLC | 521212d6-57fd-4a7a-e063-6294a90a2a18 | 2026-05-18 | Warnings | M017 |
| Burn Relief | LIDOCAINE | WALMART INC. | 15af4557-4baf-c177-e063-6294a90a7a5b | 2026-05-18 | Warnings | M017 |
| Blistex Maximum Hydration Lip | CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL | Blistex Inc. | fed223bc-edf3-46eb-b678-acb906f9ef11 | 2026-05-18 | Warnings | M017 |
| Tiger Balm | CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | 5066dc10-e4d5-49e9-9a5f-0ac220cfbf28 | 2026-05-18 | Warnings | M017 |
| Deep Blue Mini | MENTHOL | doTERRA International, LLC | 51dd58a8-1fd5-9cd7-e063-6394a90a1f72 | 2026-05-15 | Warnings | M017 |
| Biofreeze Overnight Gel | MENTHOL | Reckitt Benckiser LLC | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 2026-05-15 | Warnings | M017 |
| Biofreeze Professional | MENTHOL, UNSPECIFIED FORM | Reckitt Benckiser LLC | 00bba5d2-b0e0-701c-e063-6294a90a5741 | 2026-05-15 | 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 |