Dibucaine
- Product NDC
- 57896-131
- 11-digit product format
- 578960131
- Labeler code
- 57896
- Product ID
- 57896-131_29b472b9-6743-2403-e063-6294a90a22d0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dibucaine 1%
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Geri-Care Pharmaceuticals, Corp
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-09-22
- 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 |
|---|---|
| afe88610-5cac-960e-e053-2a95a90a7ba4 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-131-01 | Dibucaine | 28 g in 1 TUBE | OINTMENT | 28 | 4 | |
| 57896-131-01 | Dibucaine | 1 in 1 BOX | OINTMENT | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-131-01 | GM - Gram | 57896-131 | 4a04f944-b7c2-4d7f-89f2-4e034d961b08 | 1 | 2021-10-08 |
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 |
|---|---|---|---|---|---|---|
| PREPARATION H MEDICATED WIPES | WITCH HAZEL | Haleon US Holdings LLC | 8d9961f0-1ecf-d7fb-b6b4-856d636d68e1 | 2026-03-17 | Warnings | M015 |
| Crane Safety Burn | LIDOCAINE | Crane Safety LLC | 96d81566-6321-731e-e053-2995a90ad07d | 2026-03-16 | Warnings | M015 |
| Signature Lidocaine Pain Relief Cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4c56b3b3-33b3-a50e-e063-6394a90a955f | 2026-03-06 | Warnings | M015 |
| WowDay Medicated Hemorrhoidal Flushable Wipes | MEDICATED HEMORRHOIDAL FLUSHABLE WIPES | WowDay LLC | 4c603b27-4835-bc40-e063-6394a90a8ea2 | 2026-03-06 | Warnings | M015 |
| Numb Fast Hemorrhoidal | LIDOCAINE | Oasis Plus LLC | a00ffed7-8034-4cc0-87c4-3c793c1bcd6e | 2026-03-03 | Warnings | M015 |
| Curist Lidocaine Relief | LIDOCAINE 5% | Little Pharma, Inc. | f562b57d-6592-93fa-e053-2995a90ae3e0 | 2026-03-02 | Warnings | M015 |
| Therapain Plus | MENTHOL ROLL-ON | Epic Laboratories, LLC | 0249cfdf-b7c4-f27d-e063-6294a90aaa26 | 2026-03-02 | Warnings | M015 |
| Liposomal Hemorrhoid Master | LIDOCAINE , PHENYLEPHRINE HCL | Clinical Resolution Laboratory, Inc. | a1e15d2a-44b6-4d9c-89c2-0ff12285724e | 2026-03-02 | Warnings | M015 |
| Equate Hemorrhoid Relief | LIDOCAINE | Walmart Inc. | 48646860-ed5d-62a0-e063-6394a90abb23 | 2026-03-01 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | The Kroger Co. | bbf2efd7-f181-403b-ac5f-695f7ba15875 | 2026-02-27 | Warnings, Adverse reactions | M015 |
| Dermatool Hemorrhoidal | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Papalo Group LLC | 4bc06f41-7733-ebd0-e063-6294a90af7a8 | 2026-02-26 | Warnings | M015 |
| Megababe Fun Gal Stuff Antifungal | CLOTRIMAZOLE | Megababe LLC | c599d27b-fdb0-465f-9e43-13d32c520a92 | 2026-02-25 | Warnings | M015 |
| Witch Hazel | WITCH HAZEL | Better Living Brands, LLC | 0355edab-b6f7-4e59-bce1-cf6a8897b989 | 2026-02-24 | Warnings, Adverse reactions | M015 |
| Zinc Oxide and Menthol | ZINC OXIDE, MENTHOL | Akron Formulations India Private Limited | 4b84556c-521f-eebd-e063-6394a90a8e1e | 2026-02-23 | Warnings | M015 |
| Calprotect | MENTHOL, ZINC OXIDE | Reliable 1 Laboratories LLC | 09fb2810-0cc1-b2e2-e063-6294a90a4576 | 2026-02-19 | Warnings | M015 |
| Oxify | LIDOCAINE 5% | Weeks & Leo Compnay, INC. | 41d9d0b4-33e7-7e05-e063-6394a90a1011 | 2026-02-17 | Warnings | M015 |
| WowDay Hemorrhoid and Fissure Cream | HEMORRHOID AND FISSURE CREAM | WowDay LLC | 47ba86ad-240a-e733-e063-6394a90a24e3 | 2026-02-12 | Warnings | M015 |
| Gniby - LIDOCAINE ANORECTAL HEMORRHOIDAL | NUMBING | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 4a5f59f1-c11a-e2eb-e063-6394a90a3e27 | 2026-02-10 | Warnings | M015 |
| Numb Master | LIDOCAINE | Clinical Resolution Laboratory, Inc. | 0921c824-a8a9-4707-a480-c750192983f5 | 2026-02-09 | Warnings | M015 |
| Signature Care Hemorrhoidal | MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI | Better Living Brands, LLC | 3c8b43f3-6e1e-499e-ba71-ffdf836f6743 | 2026-02-05 | Warnings | M015 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238784 | dibucaine 1 % Rectal Ointment | PSN | afe88610-5cac-960e-e053-2a95a90a7ba4 | 4 |
| 238784 | dibucaine 0.01 MG/MG Rectal Ointment | SCD | afe88610-5cac-960e-e053-2a95a90a7ba4 | 4 |
| 238784 | dibucaine 1 % Rectal Ointment | SY | afe88610-5cac-960e-e053-2a95a90a7ba4 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57896-131-01 | 57896013101 | 1 TUBE in 1 BOX (57896-131-01) / 28 g in 1 TUBE | 1 tube | 2020-09-22 | 0000-00-00 | No | No | Current |