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 |
|---|---|---|---|---|---|---|
| Family wellness | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | FRONT PHARMACEUTICAL PLC | cfdd61e3-e12e-491c-b2a8-90fae19e8870 | 2023-10-27 | Warnings | M015 |
| Family Wellness | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM | FRONT PHARMACEUTICAL PLC | eb1785f4-5876-443b-b175-9b59d65d1a48 | 2023-10-26 | Warnings | M015 |
| CVS Health Hemorrhoidal Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | FRONT PHARMACEUTICAL PLC | cb448d78-553c-4e65-80c5-d4b31d7b3661 | 2023-10-26 | Warnings | M015 |
| Family Wellness | PHENYLEPHRINE HCL, PETROLATUM, MINERAL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bfa195d7-d87f-43b5-bbf1-7ec3a451de05 | 2023-10-25 | Warnings | M015 |
| MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots | LIDOCAINE | CVS PHARMACY, INC | 82aa128a-44cd-4907-b0f7-8a31e086d3e6 | 2023-10-25 | Warnings | M015 |
| TheraPlus Plus | PHENYLEPHRINE HCI | Zhejiang Jingwei Pharmaceutical Co., Ltd. | edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d | 2023-10-25 | Warnings | M015 |
| Assured Bikini Smooth Cream | LIDOCAINE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fb9ddde3-3f40-467e-8aff-26570144f0fc | 2023-10-25 | Warnings | M015 |
| Hemorrhoidal Cream | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM | Cardinal Health 110, LLC. dba Leader | 85a51d5c-679e-1959-e053-2a91aa0a76d5 | 2023-10-25 | Warnings | M015 |
| Family Wellness | GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fde9cd90-d63c-4058-b46e-511fecea36ec | 2023-10-24 | Warnings | M015 |
| Lidocaine 5% | LIDOCAINE | Apnar Pharma LP | ceedce20-5723-5a9a-e053-2a95a90a17a1 | 2023-10-21 | Warnings | M015 |
| Numquick Topical Analgesic | EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE | Unit Dose, Ltd. | 3f64cbd3-6745-4397-9767-3adc3b301e0e | 2023-10-19 | Warnings | M015 |
| Healquick Tattoo Balm | PETROLATUM | Unit Dose, Ltd. | 96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86 | 2023-10-19 | Warnings | M015 |
| Numpot Topical Anesthetic | LIDOCAINE, PETROLATUM | Unit Dose, Ltd. | 9143b50b-7d76-4545-aa2e-1bb77ffb44ae | 2023-10-19 | Warnings | M015 |
| Microcaine Topical Analgesic | LIDOCAINE | Unit Dose, Ltd. | 5e8fa8b5-0524-4201-91e1-83e59a8f0415 | 2023-10-19 | Warnings | M015 |
| Numstick | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 127bbd87-5402-4da2-abf3-dac6367735ec | 2023-10-18 | Warnings | M015 |
| ADVANCED NUMB Topical Anesthetic | LIDOCAINE HYDROCHLORIDE | Uber Scientific, LLC | 859d1cad-badf-4c42-9b08-daacb3fae8b4 | 2023-10-13 | Warnings | M015 |
| Hemorrhoidal Pain Relief with Aloe and VitaminE | HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE | NeilMed pharmaceuticals Inc. | 076b5021-8ba0-0204-e063-6294a90a3337 | 2023-10-11 | Warnings | M015 |
| Zensa Numbing Gel | LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% | Alera Skin Care Products Inc. | 065a6eec-3896-0da8-e063-6394a90a849d | 2023-09-27 | 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 |