Mirakel Pain and Itch Relief
- Product NDC
- 78589-233
- 11-digit product format
- 785890233
- Labeler code
- 78589
- Product ID
- 78589-233_29b77abb-b9cb-c24d-e063-6394a90a8110
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine 20%, Resorcinol 3%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sanvio, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-07-11
- Substance
- BENZOCAINE; RESORCINOL
- Active strength
- 20; 3 g/100g; 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
- Mirakel Pain and Itch Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
| RESORCINOL | 3 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| YUL4LO94HK | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 248341 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ed34d728-0275-e209-e053-2995a90a93ff | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78589-233-02 | Mirakel Pain and Itch Relief | 95 g in 1 TUBE | CREAM | 95 | 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 |
|---|---|---|---|---|---|---|
| BENGAY Tropical Jasmine | LIDOCAINE | Kenvue Brands LLC | c416320a-c0d7-401e-b0fa-44114d76a557 | 2024-11-06 | Warnings | M017 |
| Bengay Ultra Strength Large Size | MENTHOL, UNSPECIFIED FORM | Kenvue Brands LLC | f57ccc33-400b-4401-a348-c54d1eb9f5d0 | 2024-11-06 | Warnings | M017 |
| Band Aid Antiseptic Cleansing To Go | BENZALKONIUM CHLORIDE, PRAMOXINE HCL | Kenvue Brands LLC | d5749cba-32f3-cf9c-e053-2a95a90a4416 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 26473383-282c-fb10-e063-6394a90a5fa2 | 2024-11-06 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | GOLDEN TIGER DISTRIBUTION L.L.C. | 1b6f929a-db65-8a02-e063-6394a90a8b59 | 2024-11-06 | Warnings | M017 |
| Meijer Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | bd6f04f9-a23b-45f6-bce2-1ef7203198e1 | 2024-11-06 | Warnings | M017 |
| Meijer Cold and Hot Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | 6d356563-9098-4994-8ad8-819a8033a9f4 | 2024-11-06 | Warnings | M017 |
| TopCare Maximum Strength Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM | Topco Associates LLC | dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab | 2024-11-05 | Warnings | M017 |
| Aveeno Restorative Skin Therapy Itch Relief Balm | PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 61824ca7-a2d3-4830-b2bb-149a3222bfc8 | 2024-11-05 | Warnings | M017 |
| Aveeno Hydrocortisone ANTI-ITCH | HYDROCORTISONE | Kenvue Brands LLC | 233de4d7-e533-40cd-a5ed-e8b09abc626e | 2024-11-05 | Warnings | M017 |
| STING MASTER | LIDOCAINE HYDROCHLORIDE | Les Technologies Ptero, Inc | 94c6fd1f-9e74-420b-9d25-61b37953b838 | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 | 2024-11-05 | Warnings | M017 |
| Alocane Max | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products LLC | 0a35ac19-6883-a733-e063-6294a90ad22d | 2024-11-05 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | cfe8114b-df65-064b-e053-2a95a90a33f6 | 2024-11-05 | Warnings | M017 |
| Alocane Botanicals | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 02a8e5c7-56f4-eb0d-e063-6294a90a80cd | 2024-11-05 | Warnings | M017 |
| Alocane Emergency Burn Pads | LIDOCAINE HYDROCHLORIDE | Quest Products, Inc. | fe58bb89-7216-4121-afd3-d1438bdfbfa2 | 2024-11-05 | Warnings | M017 |
| Licefreee AfterLice | PRAMOXINE HCI | Tec Laboratories Inc. | 06c4cc42-a215-3949-e063-6394a90a665e | 2024-11-05 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | ASO LLC | cb9505b7-222d-3a24-e053-2a95a90a0b64 | 2024-11-05 | Warnings | M017 |
| TopCare Pain Relieving Analgesic | LIDOCAINE HYDROCHLORIDE | Topco Associates LLC | 6b4783e0-1987-4838-9e8c-b95426d62b28 | 2024-11-05 | Warnings | M017 |
| Eagle Green Balm | CAMPHOR MENTHOL | Borden Company (Private) Limited | 6f7a796b-a31c-0e60-e053-2a91aa0a022b | 2024-11-04 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 248341 | benzocaine 20 % / resorcinol 3 % Topical Cream | PSN | ed34d728-0275-e209-e053-2995a90a93ff | 2 |
| 248341 | benzocaine 200 MG/ML / resorcinol 30 MG/ML Topical Cream | SCD | ed34d728-0275-e209-e053-2995a90a93ff | 2 |
| 248341 | benzocaine 20 % / resorcinol 3 % Topical Cream | SY | ed34d728-0275-e209-e053-2995a90a93ff | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78589-233-02 | 78589023302 | 95 g in 1 TUBE (78589-233-02) | 95 g | 2022-07-11 | 0000-00-00 | No | No | Current |