What is NDC 58578-0517?

58578-0517 is the product NDC for CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse, Sodium fluoride .02 g/100mL rinse, listed with the FDA by Rowpar Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse (Sodium Fluoride).

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 Silver Sensitive Mouth Rinse Fluoride Rinse?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 58578-0517

NDC codes

FDA NDC Directory

Product NDC (as listed)58578-0517Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58578-0517Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
58578-0517-1	58578051701	1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLEMarketed from Jan 1, 2024
58578-0517-2	58578051702	2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLEMarketed from Jan 1, 2024
58578-0517-3	58578051703	3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLEMarketed from Jan 1, 2024
58578-0517-4	58578051704	946 mL in 1 BOTTLE (58578-0517-4)Marketed from Jan 1, 2024

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 Silver Sensitive Mouth Rinse Fluoride RinseSuffix: Fluoride Rinse
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — .02 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 021
Marketing start: Jan 1, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 58578-0517_5b621757-befa-4ce3-920d-b884aca94420SPL ID 5b621757-befa-4ce3-920d-b884aca94420SPL set ID 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796RxCUI 313029UNII 8ZYQ1474W7

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

N458578051701 followed by a unit qualifier and the quantity

Package 58578-0517-01. 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 Apr 1, 2026.

Indications (excerpt from the label)

Uses ▪ Aids in the prevention of dental cavities

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58578-0517

What is NDC 58578-0517?: 58578-0517 is the product NDC for CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse, Sodium fluoride .02 g/100mL rinse, listed with the FDA by Rowpar Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse (Sodium Fluoride).
What is the active ingredient?: Sodium fluoride.
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 Silver Sensitive Mouth Rinse Fluoride Rinse?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 021

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 021
Product	Strength	Form · route	Labeler	Product NDC
365 Everyday Value Cavity Fighting and Whiteningsodium monoflourophosphate	Sodium monofluorophosphate .13 g/100g	Paste, DentifriceDental	Whole Foods Market, Inc.	42681-5002
365 Everyday Value Kids Flouridesodium monofluorophosphate	Sodium monofluorophosphate .13 g/100g	Paste, DentifriceDental	Whole Foods Market, Inc.	42681-5276
3ECARE Dual FormulaToothpastefor sensitiveteethpotassium nitrate sodium monofluorophosphate	Potassium nitrate 5 g/100g; Sodium monofluorophosphate 5 g/100g	Paste, DentifriceDental	Hangzhou Namei Zhikang Technology Co., Ltd.	87514-004
3ECARE Dual FormulaWhiteningToothpastesodium fluoride	Sodium fluoride .155 g/100g	Paste, DentifriceDental	Hangzhou Namei Zhikang Technology Co., Ltd.	87514-003
A and H Plus Therabreath Breath Freshnerssodium fluoride	Sodium fluoride .243 g/100g	Paste, DentifriceOral	Church & Dwight Co., Inc.	10237-676
ACT Anticavity Fluoride Arctic Blastsodium fluoride	Sodium fluoride .2 mg/mL	MouthwashTopical	Chattem, Inc.	41167-0937
ACT Anticavity Fluoride Cinnamonsodium fluoride	Sodium fluoride .2 mg/mL	RinseTopical	Chattem, Inc.	41167-0940
ACT Anticavity Fluoride Kids Bubblegumsodium fluoride	Sodium fluoride .2 mg/mL	RinseTopical	Chattem, Inc.	41167-0944
ACT Anticavity Fluoride Kids Groovy Grapesodium fluoride	Sodium fluoride .2 mg/mL	RinseTopical	Chattem, Inc.	41167-0945
ACT Anticavity Fluoride Kids Wild Watermelonsodium fluoride 0.24 (0.14 w/v fluoride ion)	Sodium fluoride 1.4 mg/g	PasteTopical	Chattem, Inc.	41167-0924
ACT Anticavity Fluoride Mintsodium fluoride	Sodium fluoride .2 mg/mL	RinseTopical	Chattem, Inc.	41167-0942
ACT Kids Anticavity Fluoride Bubble Gum Blowoutsodium fluoride	Sodium fluoride 1.4 mg/g	PasteTopical	Chattem, Inc.	41167-0922
ACT Kids Anticavity Fluoride Groovy Grapesodium fluoride	Sodium fluoride 1.4 mg/g	Paste, DentifriceTopical	Chattem, Inc.	41167-0926
ACT Kids Anticavity Fluoride Pineapple Punchsodium fluoride	Sodium fluoride .2 mg/mL	MouthwashTopical	Chattem, Inc.	41167-0953
ACT Kids Anticavity Fluoride Wild Watermelonsodium fluoride	Sodium fluoride .5 mg/mL	RinseTopical	Chattem, Inc.	41167-0938
ACT Kids Berry Blastsodium fluoride	Sodium fluoride .5 mg/mL	RinseOral	Chattem, Inc.	41167-0976
ACT Kids Pure Protect Anticavity- Simply Strawberrysodium fluoride	Sodium fluoride .5 mg/mL	RinseOral	Chattem, Inc.	41167-0915
ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride	Sodium fluoride .2 mg/mL	MouthwashTopical	Chattem, Inc.	41167-0957
ACT Restoring Anticavity Fluoride Cool Mintsodium fluoride	Sodium fluoride .09 mg/mL	MouthwashTopical	Chattem, Inc.	41167-0981
ACT Restoring Anticavity Fluoride Mint Burstsodium fluoride	Sodium fluoride .2 mg/mL	MouthwashOral	Chattem, Inc.	41167-0978

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CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse (Sodium fluoride) NDC 58578-0517