Lidothol
- Product NDC
- 76420-253
- 11-digit product format
- 764200253
- Labeler code
- 76420
- Product ID
- 76420-253_e837dbef-8ea9-e5cb-e053-2995a90a8ec8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LIDOCAINE HCl, MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2019-04-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-253-04 | Lidothol | 1 in 1 BOX | GEL | 1 | | 2 |
| 76420-253-04 | Lidothol | 99.2 g in 1 TUBE | GEL | 99.2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-253 | LIDOTHOL (LIDOCAINE HCL, MENTHOL) GEL [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220911_6d7adaca-67dd-4a4b-a85c-d1c2a568dee2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-253-04 | 76420025304 | 1 TUBE in 1 BOX (76420-253-04) / 99.2 g in 1 TUBE | 1 tube | 2022-07-19 | 0000-00-00 | No | No | Current |