RectaSmoothe
- Product NDC
- 69315-301
- 11-digit product format
- 693150301
- Labeler code
- 69315
- Product ID
- 69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine 5%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Leading Pharma, LLC
- Application
- part346
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-04-01
- Substance
- LIDOCAINE
- Active strength
- 5 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
- RectaSmoothe
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | 5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987 |
| Rxcui | 1366789 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-301-30 | RectaSmoothe | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 69315-301-30 | RectaSmoothe | 30 g in 1 TUBE | CREAM | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-301 | RECTASMOOTHE (LIDOCAINE 5%) CREAM [LEADING PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20171223_78120481-b780-4e41-885d-11e424d1f717.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-301-30 | 69315030130 | 1 TUBE in 1 CARTON (69315-301-30) / 30 g in 1 TUBE | 1 tube | 2016-05-15 | 0000-00-00 | No | No | Current |