What is NDC 58657-322?

58657-322 is the product NDC for Sodium Fluoride, Sodium fluoride .5 mg/mL solution/ drops, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sodium Fluoride?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sodium Fluoride NDC 58657-322 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0322Add 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	Copy
58657-322-50	5865703225058657032250	50 mL in 1 BOTTLE, DROPPER (58657-322-50)Marketed from Aug 15, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Sodium Fluoride
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — .5 mg/mL
Dosage form: Solution/ drops
Route: Oral
Labeler: Method Pharmaceuticals, LLCNDC labeler code 58657
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Aug 15, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 58657-322_41b6cf2b-2810-7774-e063-6394a90ac1fbSPL ID 41b6cf2b-2810-7774-e063-6394a90ac1fbSPL set ID 35dcc144-130d-4ec7-a266-c084008ac70cRxCUI 315102UNII 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

N458657032250 followed by a unit qualifier and the quantity

Package 58657-0322-50. 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 Oct 21, 2025.

Indications (excerpt from the label)

Indications and Usage As a supplemental source of Fluoride. It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries.1 Sodium Fluoride Drops were developed to provide systemic Fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water Fluoride level does not exceed 0.6 ppm F.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-322

What is NDC 58657-322?: 58657-322 is the product NDC for Sodium Fluoride, Sodium fluoride .5 mg/mL solution/ drops, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sodium Fluoride.
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sodium Fluoride?: 5 other product NDCs are listed under this name. See all Sodium Fluoride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sodium Fluoride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
sodium fluoride	Sodium fluoride .1 mg/mL	MouthwashOral	Lidl US, LLC	71141-576	71141-0576-86
Sodium Fluorideclear mint, gel toothpaste	Sodium fluoride 220 mg/g	GelDental	Dynarex Corporation	67777-180	67777-0180-0367777-0180-0667777-0180-08+1 more
Sodium fluoride	Sodium fluoride .2 mg/mL	MouthwashOral	Demoulas Super Markets, Inc	53942-581	53942-0581-86
Sodium Fluoride	Sodium fluoride 2.43 mg/g	Paste, DentifriceDental	Safco Dental Supply LLC	67239-0226	67239-0226-00
Sodium Fluoride	Sodium fluoride 2.43 mg/g	Paste, DentifriceDental	Safco Dental Supply LLC	67239-0227	67239-0227-00