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 |
|---|---|---|---|---|---|---|
| Lidocaine 4% Patch | LIDOCAINE | Aldermed Inc. | 57994923-20fc-9d9d-e063-6394a90a22c9 | 2026-07-27 | Warnings | M017 |
| Lidocaine 4% Patch | LIDOCAINE | Aldermed Inc. | 579a5012-837a-828b-e063-6294a90a4fb2 | 2026-07-27 | Warnings | M017 |
| Original Pain Relief | TOPICAL ANALGESIC LOTION | Real Time Pain Relief Inc | 579bd303-9a50-4d66-e063-6294a90a6141 | 2026-07-27 | Warnings | M017 |
| Lidfix Pain Relief Patch Lidocaine | LIDOCAINE | HETERO HEALTHCARE LIMITED | 2149f0e3-1983-4f02-929e-ecd20357f4bb | 2026-07-27 | Warnings | M017 |
| RectoProtect | LIDOCAINE | Akron Pharma Inc. | 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb | 2026-07-27 | Warnings | M017 |
| OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEF | MENTHOL | OWELL NATURAL 8 LLC | 57a124b4-66c6-2474-e063-6294a90ab0d7 | 2026-07-27 | Warnings | M017 |
| Icy Hot Performance Dry | MENTHOL 16%, CAMPHOR 11% | Chattem, Inc. | 8927570f-761b-4d83-8612-30077224fdb8 | 2026-07-27 | Warnings | M017 |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 578675e8-30e7-6986-e063-6394a90a8afe | 2026-07-26 | Warnings | M017 |
| Do Me Delay Cream | BENZOCAINE | Prodigy Media | 53d5cd6b-96b8-9ba2-e063-6294a90a0d15 | 2026-07-24 | Warnings | M017 |
| Bravado Labs Delay Cream | BENZOCAINE | Prodigy Media Inc | 57269544-9cfb-4ff0-e063-6394a90adb02 | 2026-07-24 | Warnings | M017 |
| Zytherial Lidocaine 4% Pain Relief Patch | LIDOCAINE 4% PAIN RELIEF PATCH | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56db5028-b631-7981-e063-6294a90ae395 | 2026-07-24 | Warnings | M017 |
| AEROBURN | LIDOCAINE HYDROCHLORIDE | Aero Healthcare US LLC | f8fa72db-5f7a-4158-a2b3-f8bc0e12df9f | 2026-07-24 | Warnings | M017 |
| AEROSOOTHE | HYDROCORTISONE | Aero Healthcare US LLC | 22b172a2-07e8-4ebb-b0a0-dfe4f25477fa | 2026-07-24 | Warnings | M017 |
| Lidocaine Plus Pain Relieving | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | CVS Pharmacy | 49003aac-184c-ae33-e063-6294a90a29c0 | 2026-07-24 | Warnings | M017 |
| Arlun Lidocaine Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5765fbf1-e835-a11e-e063-6394a90a5ac2 | 2026-07-24 | Warnings | M017 |
| DERMFREE PAIN RELIEF | ARNICA MONTANA HPUS 7% PAIN RELIEF | Jiangxi Yudexi Pharmaceutical Co., LTD | 4bb74112-c4e7-7988-e063-6394a90ae3f1 | 2026-07-24 | Warnings | M017 |
| SERYNTH HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c667f3d-1238-2f02-e063-6394a90ab742 | 2026-07-24 | Warnings | M017 |
| DERMFREE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ca7222b-d754-9861-e063-6294a90a1b7b | 2026-07-24 | Warnings | M017 |
| REINREUDE BACK PAIN THERAPY | CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ca7d0ca-6407-1fed-e063-6394a90aaccc | 2026-07-24 | Warnings | M017 |
| SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID | NICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AID | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5821f9-605e-5391-e063-6294a90afcd2 | 2026-07-24 | 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 |