CloSYS
- Product NDC
- 58578-0613
- 11-digit product format
- 585780613
- Labeler code
- 58578
- Product ID
- 58578-0613_2db642d7-8842-4aac-9deb-6cdbd4d9f955
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrogen Peroxide
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- Rowpar Pharmaceuticals, Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-27
- Substance
- HYDROGEN PEROXIDE
- Active strength
- 1.5 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CloSYS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROGEN PEROXIDE | 1.5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BBX060AN9V |
| Rxcui | 358975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58578-0613 | CLOSYS (HYDROGEN PEROXIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] | 1 | Current NDC, 5 package rows | 20250128_299fc7b1-af6d-4bf9-810f-d35283423fe2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58578-0613-1 | 58578061301 | 473 mL in 1 BOTTLE (58578-0613-1) | 473 ml | 2025-01-27 | No | No | Current |
| 58578-0613-5 | 58578061305 | 1 BOTTLE in 1 CARTON (58578-0613-5) / 473 mL in 1 BOTTLE | 1 bottle | 2026-01-01 | No | No | Current |
| 58578-0613-7 | 58578061307 | 3 BOTTLE in 1 PACKAGE (58578-0613-7) / 473 mL in 1 BOTTLE | 3 bottle | 2025-11-18 | No | No | Current |