LUBRICAINE
- Product NDC
- 63135-727
- 11-digit product format
- 631350727
- Labeler code
- 63135
- Product ID
- 63135-727_47e9bd07-b72c-08ef-e063-6294a90a7389
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIDOCAINE 4%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- ESBA LABORATORIES INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-09-03
- Substance
- LIDOCAINE
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUBRICAINE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | 4 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63135-727-04 | LUBRICAINE | 113 g in 1 TUBE | GEL | 113 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63135-727 | LUBRICAINE (LIDOCAINE 4%) GEL [ESBA LABORATORIES INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240921_9d7416b1-607d-34e0-e053-2a95a90aa3c3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63135-727-04 | 63135072704 | 113 g in 1 TUBE (63135-727-04) | 113 g | 2019-09-03 | 0000-00-00 | No | No | Current |