Mirakel Pain Relief Roll-On
- Product NDC
- 78589-257
- 11-digit product format
- 785890257
- Labeler code
- 78589
- Product ID
- 78589-257_102f3618-13ae-37e3-e063-6294a90a8086
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine HCl
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Sanvio, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-03-01
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 4 g/100g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirakel Pain Relief Roll-On
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | 4 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A |
| Rxcui | 1010077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78589-257-03 | Mirakel Pain Relief Roll-On | 85 g in 1 BOTTLE | GEL | 85 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78589-257 | MIRAKEL PAIN RELIEF ROLL-ON (LIDOCAINE HCL) GEL [SANVIO, INC.] | 1 | Current NDC, 1 package rows | 20240131_102f3618-13ad-37e3-e063-6294a90a8086.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 78589-257-03 | 78589025703 | 85 g in 1 BOTTLE (78589-257-03) | 85 g | 2023-03-01 | No | No | Historical |