Over-the-counter drug · NDA
Chlorhexidine Gluconate NDC 16571-111
Chlorhexidine gluconate 40 mg/mL · Solution · Topical · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-111-12 | 1657101111216571011112 | 118 mL in 1 BOTTLE (16571-111-12)Marketed from Jul 26, 2023 | |
| 16571-111-24 | 1657101112416571011124 | 237 mL in 1 BOTTLE (16571-111-24)Marketed from Jul 26, 2023 | |
| 16571-111-48 | 1657101114816571011148 | 473 mL in 1 BOTTLE (16571-111-48)Marketed from Jul 26, 2023 | |
| 16571-111-95 | 1657101119516571011195 | 946 mL in 1 BOTTLE (16571-111-95)Marketed from Jul 26, 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
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 40 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019258
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 16571-111_32cca440-c887-49ab-9c52-0b43fdf87b78SPL ID 32cca440-c887-49ab-9c52-0b43fdf87b78SPL set ID d53a01eb-7213-4f19-b74f-acbf0fd54418RxCUI 211365UNII MOR84MUD8EUPC 0316571111480
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N416571011112followed by a unit qualifier and the quantityPackage 16571-0111-12. 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 surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease skin wound and general skin cleanser: helps reduce bacteria on the skin
Excerpt only. Read the full label for complete information.
About NDC 16571-111
- What is NDC 16571-111?
- 16571-111 is the product NDC for Chlorhexidine Gluconate, Chlorhexidine gluconate 40 mg/mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlorhexidine Gluconate.
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlorhexidine Gluconate?
- 23 other product NDCs are listed under this name. See all Chlorhexidine Gluconate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlorhexidine Gluconate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-1999 | 00116-1999-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | PAI Holdings, LLC dba PAI Pharma | 0121-1786 | 00121-1786-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | REMEDYREPACK INC. | 70518-4494 | 70518-4494-00 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseBuccal | VistaPharm, LLC | 66689-106 | 66689-0106-5066689-0106-99 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseDental | Major Pharmaceuticals | 0904-7035 | 00904-7035-8000904-7035-87 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Lyne Laboratories, Inc. | 0374-5080 | 00374-5080-0100374-5080-02 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate .12 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-0101 | 00116-0101-0100116-0101-04 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Preferred Pharmaceuticals, Inc. | 68788-9546 | 68788-9546-04 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-6000 | 00116-6000-0400116-6000-16 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Benco Dental | 66975-600 | 66975-0600-0466975-0600-16 |
Other NDCs under NDA 019258
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 |
|---|---|---|---|---|
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | LiquidTopical | SC Johnson Professional USA, Inc. | 11084-126 |
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | LiquidTopical | SC Johnson Professional USA, Inc. | 11084-128 |
| Halyard Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Owens & Minor, Inc. | 39892-0960 |
| Halyard Chlorhexidine Gluconatechlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Owens & Minor, Inc. | 39892-0961 |
| Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Henry Schein, Inc. | 0404-0219 |
| Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Henry Schein, Inc. | 0404-0220 |
| Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Henry Schein, Inc. | 0404-0221 |
| Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | AVA, Inc. | 42939-124 |
| Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | AVA, Inc. | 42939-125 |
| Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | AVA, Inc. | 42939-127 |
| Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | AVA, Inc. | 42939-128 |
| Scrub-Statchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Ecolab Inc. | 47593-463 |
| Scrub-Statchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Ecolab Inc. | 47593-464 |
| Scrub-Statchlorhexidine gluconate | Chlorhexidine gluconate 20 mg/mL | SolutionTopical | Ecolab Inc. | 47593-467 |
| Scrub-Statchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | Ecolab Inc. | 47593-468 |