Comfortcaine
- Product NDC
- 65008-005
- 11-digit product format
- 650080005
- Labeler code
- 65008
- Product ID
- 65008-005_4354972c-d9c9-cd90-e063-6294a90ad4c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine HCL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- QS Key West Aloe, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2004-11-12
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 40 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
- Comfortcaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | 40 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A |
| Rxcui | 1291672, 1592290 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65008-005-04 | Comfortcaine | 113 g in 1 BOTTLE, PLASTIC | GEL | 113 | | 7 |
| 65008-005-04 | Comfortcaine | 1 in 1 CARTON | GEL | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65008-005 | COMFORTCAINE (LIDOCAINE HCL) GEL [QS KEY WEST ALOE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241124_831b7c11-e437-4e74-808e-c9c1eb8b82f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65008-005-04 | 65008000504 | 1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) / 113 g in 1 BOTTLE, PLASTIC | 2023-06-23 | 0000-00-00 | No | No | Current |