Over-the-counter drug · OTC MONOGRAPH DRUG
CloSYS (Hydrogen peroxide) NDC 58578-0613
Hydrogen peroxide 1.5 g/100mL · Rinse · Oral · Rowpar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58578-0613-1 | 5857806130158578061301 | 473 mL in 1 BOTTLE (58578-0613-1)Marketed from Jan 27, 2025 | |
| 58578-0613-5 | 5857806130558578061305 | 1 BOTTLE in 1 CARTON (58578-0613-5) / 473 mL in 1 BOTTLEMarketed from Jan 1, 2026 | |
| 58578-0613-7 | 5857806130758578061307 | 3 BOTTLE in 1 PACKAGE (58578-0613-7) / 473 mL in 1 BOTTLEMarketed from Nov 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- CloSYS
- Generic name (nonproprietary)
- hydrogen peroxide
- Active ingredients
- Hydrogen peroxide — 1.5 g/100mL
- Dosage form
- Rinse
- Route
- Oral
- Labeler
- Rowpar Pharmaceuticals, Inc.NDC labeler code 58578
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 022
- Marketing start
- Listing expires
- Identifiers
- Product ID 58578-0613_2db642d7-8842-4aac-9deb-6cdbd4d9f955SPL ID 2db642d7-8842-4aac-9deb-6cdbd4d9f955SPL set ID 299fc7b1-af6d-4bf9-810f-d35283423fe2RxCUI 358975UNII BBX060AN9VUPC 0647692000125
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458578061301followed by a unit qualifier and the quantityPackage 58578-0613-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.
Excerpt only. Read the full label for complete information.
About NDC 58578-0613
- What is NDC 58578-0613?
- 58578-0613 is the product NDC for CloSYS (hydrogen peroxide), Hydrogen peroxide 1.5 g/100mL rinse, listed with the FDA by Rowpar Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CloSYS (Hydrogen Peroxide).
- What is the active ingredient?
- Hydrogen peroxide.
- Who is the labeler?
- Rowpar Pharmaceuticals, Inc., NDC labeler code 58578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CloSYS?
- 2 other product NDCs are listed under this name. See all CloSYS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CloSYS products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CloSYSsodium fluoride | Sodium fluoride .916 mg/g | Paste, DentifriceOral | Rowpar Pharmaceuticals, Inc. | 58578-0759 | 58578-0759-0158578-0759-03 |
| CloSYSsodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental, Oral | Rowpar Pharmaceuticals, Inc. | 58578-0749 | 58578-0749-0158578-0749-0258578-0749-04 |
Other NDCs under M 022
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent ReadyInCasehydrogen peroxide | Hydrogen peroxide 3 mL/100mL | LiquidTopical | P & L Development, LLC | 49580-0268 |
| Salinenasal | Sodium chloride 6.5 mg/mL | SprayNasal | Bi-Mart | 37835-998 |
| CVS Health Sensitive Enamel Repairsodium fluoride | Sodium fluoride .15 g/100g; Potassium nitrate 5 g/100g | Paste, DentifriceOral | CVS | 51316-169 |
| Ricola Max Nasal Care Cool Mentholmenthol | Menthol 15.3 mg/1 | LozengeOral | Ricola Ag | 54305-206 |
| Orajel Medicated for Toothache and Gum, Liquidbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 1 mg/mL | LiquidTopical | Church & Dwight Co., Inc. | 10237-796 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola Ag | 54305-301 |
| Throat Balm Caramel Pectinpectin | Pectin 3.8 mg/1 | LozengeOral | Ricola USA Inc. | 63667-301 |
| Hydrogen Peroxide 3 Percenthydrogen peroxide | Hydrogen peroxide 2.65 mL/100mL | LiquidTopical | Whole Foods Market | 42681-6414 |
| Sore throat cherryphenol | Phenol 1.4 g/100mL | SprayOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-376 |
| Crest Pro-Health Gum DetoxifyWinter Mintcetylpyridinium chloride | Cetylpyridinium chloride .07 g/mL | RinseOral | The Procter & Gamble Manufacturing Company | 84126-648 |
| Crest Kids Advanced Color Changingsodium monofluorophosphate | Sodium monofluorophosphate 1.6 mg/g | Paste, DentifriceDental | Procter & Gamble Manufactura, S de R.L. de C.V. | 58933-012 |
| Sootheez Berry Lemonadepectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-4014 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Quality Choice Oral Pain Reliefbenzocaine 20%, benzalkonium chloride 1% | Benzocaine 200 mg/g; Benzalkonium chloride 10 mg/g | GelTopical | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 83324-035 |
| Rite Aid Professional Strengthbenzocaine | Benzocaine 20 g/100g | LiquidOral | Rite Aid | 11822-5340 |
| SENSODYNE Rapid Reliefstannous fluoride | Stannous fluoride 1.1 mg/g | PasteOral | Haleon US Holdings LLC | 0135-0622 |
| Iodent Oral Analgesicbenzocaine | Benzocaine 200 mg/g | GelTopical | United Exchange Corp. | 65923-094 |
| Sootheez Organic Wild Cherrypectin | Pectin 11.5 mg/3.5g | LozengeOral | BFY LLC | 72427-3714 |
| Topcare Sore Throat Menthol Flavorphenol | Phenol 1.4 g/100mL | SprayOral | TOPCO ASSOCIATES LLC | 36800-606 |
| Sensodyne Pronamel Gentle Whitening Advancedpotassium nitrate and sodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 1.15 mg/g | PasteDental | Haleon US Holdings LLC | 0135-0580 |
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