NDC 11868-390
Tronolane
Pramoxine Hcl
Tronolane is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by New Genesis/monticello Drug Llc. The primary component is Pramoxine Hydrochloride; Zinc Oxide.
| Product ID | 11868-390_db8319e2-0939-4b4d-85e9-ec9d96214865 |
| NDC | 11868-390 |
| Product Type | Human Otc Drug |
| Proprietary Name | Tronolane |
| Generic Name | Pramoxine Hcl |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2011-12-04 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part347 |
| Labeler Name | New Genesis/Monticello Drug LLC |
| Substance Name | PRAMOXINE HYDROCHLORIDE; ZINC OXIDE |
| Active Ingredient Strength | 10 mg/g; mg/g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 11868-390-59
1 TUBE in 1 CARTON (11868-390-59) > 57 g in 1 TUBE (11868-390-58)
| Marketing Start Date | 2015-03-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 11868-390-59 [11868039059]
Tronolane CREAM
| Marketing Category | OTC monograph final |
| Application Number | part347 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-03-04 |
NDC 11868-390-58 [11868039058]
Tronolane CREAM
| Marketing Category | OTC monograph final |
| Application Number | part347 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-12-04 |
NDC 11868-390-28 [11868039028]
Tronolane CREAM
| Marketing Category | OTC monograph final |
| Application Number | part347 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-12-04 |
NDC 11868-390-48 [11868039048]
Tronolane CREAM
| Marketing Category | OTC monograph final |
| Application Number | part347 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-12-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
OpenFDA Data
| SPL SET ID: | 0d5ba4f1-1178-490d-8524-143d0aa2f0ef |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Tronolane" or generic name "Pramoxine Hcl"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 11868-390 | Tronolane | Pramoxine HCl |
| 69842-263 | CVS Anti-Itch | Pramoxine HCL |
| 63868-877 | Poison Ivy Wash | Pramoxine HCl |
| 0363-0263 | Walgreen Anti-Itch | Pramoxine HCL |
Trademark Results [Tronolane]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRONOLANE 86665145 4907878 Live/Registered |
New Genesis/Monticello Drug, LLC 2015-06-17 |
 TRONOLANE 86238203 4628603 Live/Registered |
Monticello Drug Company 2014-04-01 |
 TRONOLANE 73282245 1200811 Dead/Cancelled |
Abbott Laboratories 1980-10-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.