PUREGEN LABS Maximum Strength Lidocaine
- Product NDC
- 80513-813
- 11-digit product format
- 805130813
- Labeler code
- 80513
- Product ID
- 80513-813_15cfdc73-c2f3-528e-e063-6394a90a07ae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIDOCAINE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Advanced Rx LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-22
- Substance
- LIDOCAINE
- Active strength
- 50 mg/g
- 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
- PUREGEN LABS Maximum Strength Lidocaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987 |
| Rxcui | 1366789 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80513-813-06 | PUREGEN LABS Maximum Strength Lidocaine | 170 g in 1 TUBE | CREAM | 170 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80513-813 | PUREGEN LABS MAXIMUM STRENGTH LIDOCAINE (LIDOCAINE) CREAM [ADVANCED RX LLC] | 1 | Current NDC, 1 package rows | 20240423_f4f89582-49e6-424a-bea7-0694484a7c99.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 |
|---|
| 80513-813-06 | 80513081306 | 170 g in 1 TUBE (80513-813-06) | 170 g | 2024-04-22 | No | No | Current |