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 |
|---|---|---|---|---|---|---|
| Capsaicin | CAPSAICIN | Rugby Laboratories | c5915c84-84a2-46f6-9f97-0d9873e9944a | 2024-02-12 | Warnings | M017 |
| Leader Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | 952e56ea-5cbc-4078-bd01-5d3b6864a5ce | 2024-02-09 | Warnings | M017 |
| Leader Ultra Strength Muscle Rub Topical Analgesic | CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE | Cardinal Health, 110 dba LEADER | 9d99a900-60e0-454c-98e0-2c63eb910cf1 | 2024-02-09 | Warnings | M017 |
| Pain Relieving | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | 28821ffa-a138-47b5-8857-beadf7a20d43 | 2024-02-08 | Warnings | M017 |
| Menthol Camphor Cough Suppressant Topical Analgesic Rub | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | fd0ea70a-ef12-48b1-8d9d-cc5f6417f854 | 2024-02-08 | Warnings | M017 |
| Pain Relieving Cooling | MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 3574d48a-b546-4ea7-b470-071bb328de64 | 2024-02-08 | Warnings | M017 |
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | M017 |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 8eb3e7e2-26e5-430e-89aa-40a0367c637e | 2024-02-07 | Warnings | M017 |
| Nova Natura Topical Analgesic | CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE | SEYITLER KIMYA SANAYI ANONIM SIRKETI | abf00f73-f0b1-439e-85aa-bbce8a1ec920 | 2024-02-06 | Warnings | M017 |
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | M017 |
| Pain Relieving Petro Carbo | PHENOL | J.R. Watkins, LLC. | 050cf17d-3be7-45b9-8524-ad82af309a0e | 2024-02-06 | Warnings | M017 |
| White Cream | CAMPHOR (NATURAL) AND TURPENTINE OIL | J.R. Watkins, LLC. | e4de0734-59d5-478c-86ea-66fc2ba003e7 | 2024-02-05 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Safetec of America, Inc. | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 2024-02-04 | Warnings | M017 |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | M017 |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | 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 |