Over-the-counter drug · NDA
Antiseptic Skin Cleanser (chlorhexidine gluconate 4%) NDC 0363-1061
Chlorhexidine gluconate 4 mg/100mL · Liquid · Topical · Walgreen Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1061-08 | 00363106108 | 237 mL in 1 BOTTLE, PLASTIC (0363-1061-08)Marketed from May 1, 2011 | |
| 0363-1061-15 | 00363106115 | 15 mL in 1 KIT (0363-1061-15)Marketed from Jan 1, 2017 | |
| 0363-1061-16 | 00363106116 | 473 mL in 1 BOTTLE, PUMP (0363-1061-16)Marketed from May 1, 2011 | |
| 0363-1061-18 | 00363106118 | 532 mL in 1 BOTTLE, PUMP (0363-1061-18)Marketed from Jan 11, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Antiseptic Skin Cleanser
- Generic name (nonproprietary)
- chlorhexidine gluconate 4%
- Active ingredients
- Chlorhexidine gluconate — 4 mg/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Walgreen Co.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019125
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0363-1061_26687441-6c67-cd8e-e063-6394a90a82adSPL ID 26687441-6c67-cd8e-e063-6394a90a82adSPL set ID 12aff7f5-c41e-5760-e054-00144ff8d46cRxCUI 211365UNII MOR84MUD8EUPC 0311917182728
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
N400363106108followed by a unit qualifier and the quantityPackage 00363-1061-08. 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 healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019125
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 |
|---|---|---|---|---|
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Medical-Surgical | 68599-5401 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0401 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Rite Aid Corporation | 11822-3678 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Rite Aid | 11822-0116 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0407 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Meijer Distribution, Inc. | 41250-162 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0901 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | HR Pharmaceuticals, Inc. | 69464-901 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | AmerisourceBergen Drug Corporation | 46122-137 |
| Bactoshield CHGchlorhexidine gluconate | Chlorhexidine gluconate 40 mg/mL | SolutionTopical | SC Johnson Professional USA, Inc. | 11084-039 |
| Dyna-Hex 4chlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1060 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | CVS Pharmacy, Inc. | 59779-767 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Rite Aid | 11822-0891 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0767 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
| Antiseptic Solutionchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Coloplast Corp | 11701-172 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
| Bactoshield CHGchlorhexidine gluconate 4% | Chlorhexidine gluconate 2 mg/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0039 |
Showing 20 of 32.