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 |
|---|---|---|---|---|---|---|
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | 849c60fc-e455-4c50-8adf-ac59c0ee785b | 2024-10-03 | Warnings | M017 |
| rexall anti itch maximum strength relief | HYDROCORTISONE | Dolgencorp, LLC | 894cf9ab-693a-4210-96df-605947f51b63 | 2024-10-03 | Warnings | M017 |
| equaline anti itch maximum strength | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 070000d7-7d4d-439b-9a91-851ba7c027e6 | 2024-10-03 | Warnings | M017 |
| hydrocortisone anti itch | HYDROCORTISONE | H E B | a1a9fed8-4938-48b5-81f1-d3942d534bb8 | 2024-10-03 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | ef9ea069-9b97-4bf5-aaac-deb85334dbd0 | 2024-10-03 | Warnings | M017 |
| Basic Care Hydrocortisone | HYDROCORTISONE | Amazon.com Services LLC | 7fa13ab4-5f2d-4a48-816f-1b22d5f757b2 | 2024-10-03 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | A-S Medication Solutions | dc388dc1-0c4f-4bf1-8a12-fa39892317bc | 2024-10-02 | Warnings | M017 |
| Geliga Muscular | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | fb2beb08-0ad6-a89d-e053-6294a90aa6fe | 2024-10-02 | Warnings | M017 |
| Geliga Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | da28097f-4b5c-6159-e053-2a95a90a7d96 | 2024-10-02 | Warnings | M017 |
| Circatrix | CAPSAICIN | PureTek Corporation | cd3b1256-2df8-dc26-e053-2a95a90ad049 | 2024-10-02 | Warnings | M017 |
| DermacinRx Penetral Cream | CAPSAICIN | PureTek Corporation | 1e343a52-6071-3230-e054-00144ff8d46c | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 36abfc2c-d424-4df8-968d-866342c96a56 | 2024-10-02 | Warnings | M017 |
| Eagle Balm | CAMPHOR MENTHOL | Eagle Indo Pharma, PT | 87614869-9675-2c76-e053-2a95a90a48a9 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | d9a93daa-4e24-6690-e053-2a95a90a147c | 2024-10-02 | Warnings | M017 |
| Eagle Extra Strength | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | c62a4313-2c07-5f58-e053-2995a90a083a | 2024-10-02 | Warnings | M017 |
| Eagle Medicated Aromatic | CAMPHOR MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | e272ec90-3cd9-5b70-e053-2a95a90a1df4 | 2024-10-02 | Warnings | M017 |
| RUGBY HYDROCORTISONE WITH ALOE | HYDROCORTISONE | A-S Medication Solutions | b2674075-aaa4-4c77-bcaa-a76336b3c321 | 2024-10-02 | Warnings | M017 |
| Herb Street Anti-Itch Stick | HYDROCORTISONE | Balassa Laboratories Inc. | 8717faae-59c3-4c6f-9ef1-285c0d2445ed | 2024-10-01 | Warnings | M017 |
| Herb Street Backache and Sore Muscle Relief | MENTHOL | Balassa Laboratories Inc. | aeac1b64-8689-4b3d-a41c-db41061257b5 | 2024-10-01 | 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 |