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 |
|---|---|---|---|---|---|---|
| Welly First Aid Kit Refill | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE | Dongguan Shenglian Tins Products Co., Ltd. | 4bc93855-4009-4b49-9fb4-e5864054153d | 2025-12-16 | Warnings | M017 |
| LidocainePain pain reliving gel-patch | PAIN RELIVING GEL-PATCH | Shenzhen Yuetai Electronic Commerce Co., Ltd | 461ebbdd-0f26-a333-e063-6394a90a7a3e | 2025-12-16 | Warnings | M017 |
| Zestama | CAPSAICIN | V2 Pharma LLC | c9b46759-b8df-4ff4-815e-8e032c2635c0 | 2025-12-15 | Warnings | M017 |
| equate hydrocortisone | HYDROCORTISONE | Wal-Mart Stores Inc | 70f4636d-4137-498b-ab81-0330de883e53 | 2025-12-15 | Warnings | M017 |
| SALONPAS-HOT CAPSICUM | CAPSAICIN | Hisamitsu Pharmaceutical Co., Inc. | ef5373aa-9857-4d01-95af-2d7716e54ae4 | 2025-12-15 | Warnings | M017 |
| First Aid Burn Cream | FIRST AID BURN CREAM | ProStat First Aid LLC | f70a442e-7ba7-4860-e053-6394a90ac2bd | 2025-12-15 | Warnings | M017 |
| Burn Ease, 3.5g | BURN EASE, 3.5G | ProStat First Aid LLC | 004aa18f-3a97-f454-e063-6394a90afcff | 2025-12-15 | Warnings | M017 |
| PS-3866 Burn Ease, 0.9g | PS-3866 BURN EASE, 0.9G | ProStat First Aid LLC | 004d00a5-9cff-29ff-e063-6294a90aeb8c | 2025-12-15 | Warnings | M017 |
| First Aid Burn Cream | FIRST AID BURN CREAM | ProStat First Aid LLC | 0037a1a4-d747-2567-e063-6394a90a721c | 2025-12-15 | Warnings | M017 |
| PS-3885 Burn Ease, 3.5g | PS-3885 BURN EASE, 3.5G | ProStat First Aid LLC | 004c6deb-2844-a0d0-e063-6394a90ae5e4 | 2025-12-15 | Warnings | M017 |
| 2677 First Aid Burn Cream | 2677 FIRST AID BURN CREAM | ProStat First Aid LLC | ff5bb628-8ef7-4540-e053-6394a90a55ed | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | f71b98b4-22d0-0124-e053-6394a90ae4cf | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | f71eb4f5-2280-5867-e053-6394a90aac57 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f8e6842-c889-d5d3-e063-6394a90af880 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f8c59fb-3622-2bb7-e063-6294a90adc6e | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | Front Line Safety | 0e34cb09-d8c6-f8c0-e063-6294a90a0be0 | 2025-12-15 | Warnings | M017 |
| Burn Ease 3.5g | BURN EASE 3.5G | Front Line Safety | 0f52021f-af8a-5b95-e063-6294a90a2c2a | 2025-12-15 | Warnings | M017 |
| Burn Ease | BURN EASE | ProStat First Aid LLC | 0e25c936-e40a-e23c-e063-6294a90ac0e4 | 2025-12-15 | Warnings | M017 |
| Sting Relief Wipes | STING RELIEF WIPES | ProStat First Aid LLC | 0e20252a-5ecb-2526-e063-6294a90a8cde | 2025-12-15 | Warnings | M017 |
| First Aid Burn Cream | FIRST AID BURN CREAM | Front Line Safety | 0f4ce2c2-f306-d95f-e063-6394a90ae7b3 | 2025-12-15 | 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 |