Lidothol
- Product NDC
- 80425-0516
- 11-digit product format
- 804250516
- Labeler code
- 80425
- Product ID
- 80425-0516_3467f4f8-72ee-4446-e063-6294a90a80c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HCl, MENTHOL
- Dosage form
- GEL
- Route
- CUTANEOUS
- Labeler
- Advanced Rx of Tennessee, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2025-05-05
- Substance
- LIDOCAINE HYDROCHLORIDE; MENTHOL
- Active strength
- 4.5; 5 g/100g; 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
- Lidothol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | 4.5 g/100g |
| MENTHOL | 5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A, L7T10EIP3A |
| Rxcui | 2257313 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0516-1 | Lidothol | 99.2 g in 1 TUBE | GEL | 99.2 | | 1 |
| 80425-0516-1 | Lidothol | 1 in 1 BOX | GEL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0516 | LIDOTHOL (LIDOCAINE HCL, MENTHOL) GEL [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20250508_3467f4c7-122c-40df-e063-6394a90ae36e.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 |
|---|
| 80425-0516-1 | 80425051601 | 1 TUBE in 1 BOX (80425-0516-1) / 99.2 g in 1 TUBE | 1 tube | 2025-05-05 | No | No | Historical |