Chlorhexidine Gluconate, 0.12% Oral Rinse Solution NDC 81033-512

NDC codes

FDA NDC Directory

Product NDC (as listed)81033-512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81033-0512Add 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
81033-512-50	81033051250	100 CUP, UNIT-DOSE in 1 CARTON (81033-512-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-512-15)Marketed from Aug 15, 2023

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): Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Generic name (nonproprietary): chlorhexidine gluconate, 0.12% oral rinse
Active ingredients: Chlorhexidine gluconate — 1.2 mg/mL
Dosage form: Solution
Route: Dental
Labeler: Kesin Pharma Corporation
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075561
Marketing start: Aug 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cell Wall Integrity (Physiologic effect)
Identifiers: Product ID 81033-512_2d91fb6c-a2a4-5fcf-e063-6294a90aa15cSPL ID 2d91fb6c-a2a4-5fcf-e063-6294a90aa15cSPL set ID 326c15fc-90d8-48de-abd0-61e0c4165529RxCUI 834127UNII MOR84MUD8E

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N481033051250 followed by a unit qualifier and the quantity

Package 81033-0512-50. 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 Feb 7, 2025.

Indications (excerpt from the label)

INDICATION INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075561

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

FDA NDC Directory listings under ANDA 075561
Product	Strength	Form · route	Labeler	Product NDC
Chlorhexidine Gluconate Oral Rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Atlantic Biologicals Corp.	17856-2128
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Bajaj Medical, LLC	61037-469
Chlorhexidine Gluconate Oral Rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	NuCare Pharmaceuticals,Inc.	68071-3630
Chlorhexidine Gluconate Oral Rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Rising Pharma Holdings, Inc.	16571-128
Chlorhexidine Gluconate Oral Rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Brisk Pharmaceuticals	73614-203
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Safco Dental Supply LLC	67239-0225
CleanCare Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	Safco Dental Supply LLC	67239-0225
Chlorhexidine Gluconate, 0.12% Oral Rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	American Health Packaging	60687-714
Chlorhexidine Gluconate, 0.12% Oral Rinse Solutionchlorhexidine gluconate, 0.12% oral rinse	Chlorhexidine gluconate 1.2 mg/mL	SolutionDental	A2A Integrated Pharmaceuticals, LLC	73141-512