Lidothol ES
- Product NDC
- 80425-0561
- 11-digit product format
- 804250561
- Labeler code
- 80425
- Product ID
- 80425-0561_49ef3680-e34f-1fe7-e063-6294a90a959f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- menthol 5%, lidocaine 4%
- Dosage form
- SYSTEM
- Route
- TRANSDERMAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-02-02
- Substance
- LIDOCAINE; MENTHOL
- Active strength
- .056; .07 g/g; g/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lidothol ES
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | .056 g/g |
| MENTHOL | .07 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987, L7T10EIP3A |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0561-1 | Lidothol ES | 1 in 1 POUCH | SYSTEM | 1 | | 1 |
| 80425-0561-1 | Lidothol ES | 15 in 1 BOX | SYSTEM | 15 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0561-1 | 80425056101 | 15 POUCH in 1 BOX (80425-0561-1) / 1 PATCH in 1 POUCH / 1.38 g in 1 PATCH | 15 pouch | 2026-02-02 | No | No | Historical |