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 |
|---|---|---|---|---|---|---|
| CVS Regular Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | CVS | 87473ace-d834-e43f-e053-2a95a90a819c | 2023-12-11 | Warnings | M017 |
| Katinko External Analgesic Oil | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | 5881fc35-3293-4f0b-801a-afcd6feb9496 | 2023-12-08 | Warnings | M017 |
| Katinko Pain And Itch Relieving | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Greenstone Pharmaceutical Inc. | fe907fa4-4a01-4974-b71f-9cd980b4eaa2 | 2023-12-08 | Warnings, Adverse reactions | M017 |
| Cycle | MENTHOL | La Mend, Inc. | cfc0bcde-ef91-1e6c-e053-2a95a90ab79e | 2023-12-07 | Warnings | M017 |
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | M017 |
| Quatriderm Anti-itch | HYDROCORTISONE | OPMX LLC | 83e59e10-9878-e5c2-e053-2a91aa0af25e | 2023-12-04 | Warnings | M017 |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | M017 |
| Overnight Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | 2cbd0966-4cf9-4271-bd53-6672b1ed2a99 | 2023-12-04 | Warnings | M017 |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | M017 |
| Liberdol Topical Analgesic | METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC) | ViaDerma Distribution, Inc | ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8 | 2023-12-01 | Warnings | M017 |
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | Warnings | M017 |
| Tact Cool Jelly | DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL | Sato Pharmaceutical Co., Ltd. | f34872c9-91b9-49db-8e41-5b54a069284a | 2023-12-01 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 348fde05-2797-4410-a1b2-99e64187c4fe | 2023-12-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Proficient Rx LP | 85a7809e-c43f-4138-a85b-44e1b586def5 | 2023-12-01 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 66681906-c5f5-4c57-bb43-9c83cccc0062 | 2023-12-01 | Warnings | M017 |
| Lidozen Patch | LIDOCAINE, MENTHOL | Proficient Rx LP | c0df4b8b-2679-4652-9144-a8db916a186b | 2023-12-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 7c300dec-cefd-4b79-a948-a917b7708a04 | 2023-12-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 2adf3c4d-636f-4e02-b501-946b4df5f5d6 | 2023-12-01 | Warnings | M017 |
| Lidozen | LIDOCAINE, MENTHOL | Proficient Rx LP | 488d665c-a4fe-4a69-bab3-34b2347f4b05 | 2023-12-01 | Warnings | M017 |
| Thera Plus Max Strength Lidocaine Pain Relief Liquid | LIDOCAINE HYDROCHLORIDE | Fourstar Group USA, Inc. | 0a228b06-0e1c-6c75-e063-6294a90a9a0e | 2023-11-30 | 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 |