NDC 69315-301
RectaSmoothe
Lidocaine 5%
RectaSmoothe is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Lidocaine.
| Product ID | 69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c |
| NDC | 69315-301 |
| Product Type | Human Otc Drug |
| Proprietary Name | RectaSmoothe |
| Generic Name | Lidocaine 5% |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2011-04-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Labeler Name | Leading Pharma, LLC |
| Substance Name | LIDOCAINE |
| Active Ingredient Strength | 5 g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 69315-301-30
1 TUBE in 1 CARTON (69315-301-30) > 30 g in 1 TUBE
| Marketing Start Date | 2016-05-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 69315-301-30 [69315030130]
RectaSmoothe CREAM
| Marketing Category | OTC monograph final |
| Application Number | part346 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2016-05-15 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LIDOCAINE | 5 g/100g |
OpenFDA Data
| SPL SET ID: | 78120481-b780-4e41-885d-11e424d1f717 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "RectaSmoothe" or generic name "Lidocaine 5%"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69315-301 | RectaSmoothe | Lidocaine 5% |
| 24357-702 | Anecream 5 | Lidocaine 5% |
| 70942-183 | Doctor Butlers Numb It All Cream | Lidocaine 5% |
| 72839-265 | Formula 2 Skin Care | Lidocaine 5% |
| 42291-400 | Lidocaine | Lidocaine 5% |
| 0363-4530 | Lidocaine 5% | Lidocaine 5% |
| 42858-118 | Lidocaine 5% | Lidocaine 5% |
| 63629-2472 | Lidocaine 5% | Lidocaine 5% |
| 68752-015 | Lidocaine 5% | Lidocaine 5% |
| 70518-3522 | Lidocaine 5% | Lidocaine 5% |
| 72275-716 | Lidovix L | Lidocaine 5% |
| 63135-811 | LIPOCAINE 5 | LIDOCAINE 5% |
| 63135-924 | LUBRICAINE 5 | LIDOCAINE 5% |
| 82429-203 | NUMB | Lidocaine 5% |
| 72839-141 | Rectal Care Cream | Lidocaine 5% |
| 11822-0265 | Rite Aid Rectal Care | Lidocaine 5% |
| 63135-581 | TOPICAINE 5 | LIDOCAINE 5% |
| 57483-108 | Xyralid | Lidocaine 5% |
Trademark Results [RectaSmoothe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RECTASMOOTHE 86653639 5037563 Live/Registered |
Leading Pharma, LLC 2015-06-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.