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 |
|---|---|---|---|---|---|---|
| Roll Pain Away | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547e647b-0205-221c-e063-6294a90a757c | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lemongrass | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef5c0-bc31-d83e-e063-6394a90abfa6 | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lavender | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef2d9-f5c7-9de1-e063-6394a90a218b | 2026-06-17 | Warnings | M017 |
| Velloryn EXTRA STRENGTH NEUROPATHY | VELLORYN EXTRA STRENGTH NEUROPATHY | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 547f755f-c65c-37ef-e063-6394a90aa220 | 2026-06-17 | Warnings | M017 |
| Neoteric Diabetic Skin Care 4 oz. | DIMETHICONE | RNA PHARMA LLC | 536f4e79-201b-7100-e063-6394a90a4f82 | 2026-06-16 | Warnings | M017 |
| Medi First Extra Strength Itch Relief | DIPHENHYDRAMINE, ZINC ACETATE | Unifirst First Aid Corporation | 54614e5b-8c72-d308-e063-6294a90a405d | 2026-06-16 | Warnings | M017 |
| Blue Ice Analgesic | MENTHOL | Delon Laboratories (1990) Ltd | 184ed488-6e62-40c6-bb71-1d523280fd6b | 2026-06-16 | Warnings | M017 |
| Medi-First Hydrocortisone 1 % Anti-Itch Cream | HYDROCORTISONE | Unifirst First Aid Corporation | 49f04e5d-746d-cbe9-e063-6294a90a7e88 | 2026-06-16 | Warnings | M017 |
| Lidozall Pro | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff | 2026-06-16 | Warnings | M017 |
| Tiger Balm Pain Relieving Cool | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 41590ba1-32bb-4352-97ba-d6a3cc9d0546 | 2026-06-15 | Warnings | M017 |
| HIGH POTENCY PAIN RELIEF | CAPSAICIN | Xiamen Weisiqi Technology Co., Ltd. | 543949a4-86ed-3734-e063-6394a90a24f2 | 2026-06-14 | Warnings | M017 |
| Natucure HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 49e402ed-d314-e896-e063-6294a90a826b | 2026-06-14 | Warnings | M017 |
| Nieapf NUMBING | LIDOCAINE 4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 49e7534f-bccf-4ef4-e063-6294a90aeb7f | 2026-06-14 | Warnings | M017 |
| HEALMUSZ NUMBING | HEALMUSZ NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 49976ff7-49a4-e4ed-e063-6294a90a3f78 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ HEMORRHOID FISSURE | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID FISSURE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a342ac0-6a8d-3408-e063-6394a90a9a10 | 2026-06-14 | Warnings | M017 |
| BOTASUN QUIT SMOKING Nicotine | NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4fa00db9-def5-dcfa-e063-6394a90ac8c2 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4cbb7df5-5771-ce4b-e063-6294a90aab80 | 2026-06-14 | Warnings | M017 |
| HEALMUSZ ECZEMA | HYDROCORTISONE 1% ECZEMA | Jiangxi Yudexi Pharmaceutical Co., LTD | 511e54e0-2abe-fb76-e063-6294a90ada68 | 2026-06-14 | Warnings | M017 |
| Hydrocortisone 1% Anti-ItchCream | HYDROCORTISONE | Acme United Corporation | 5425fc2b-4f25-3e64-e063-6394a90aff49 | 2026-06-13 | Warnings | M017 |
| Icy Hot Pain Relieving Balm | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | 40c8c02f-fa5f-4e80-81a0-48271fa6f94b | 2026-06-12 | 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 |