NDC codes

FDA NDC Directory
Product NDC (as listed)16571-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16571-0111Add 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 NDC11-digit (billing)PackageCopy
16571-111-121657101111216571011112118 mL in 1 BOTTLE (16571-111-12)Marketed from Jul 26, 2023
16571-111-241657101112416571011124237 mL in 1 BOTTLE (16571-111-24)Marketed from Jul 26, 2023
16571-111-481657101114816571011148473 mL in 1 BOTTLE (16571-111-48)Marketed from Jul 26, 2023
16571-111-951657101119516571011195946 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

N416571011112 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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

Other Chlorhexidine Gluconate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralXttrium Laboratories, Inc.0116-199900116-1999-16
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralPAI Holdings, LLC dba PAI Pharma0121-178600121-1786-16
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralREMEDYREPACK INC.70518-449470518-4494-00
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseBuccalVistaPharm, LLC66689-10666689-0106-5066689-0106-99
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseDentalMajor Pharmaceuticals0904-703500904-7035-8000904-7035-87
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralLyne Laboratories, Inc.0374-508000374-5080-0100374-5080-02
Chlorhexidine GluconateChlorhexidine gluconate .12 mg/mLLiquidOralXttrium Laboratories, Inc.0116-010100116-0101-0100116-0101-04
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralPreferred Pharmaceuticals, Inc.68788-954668788-9546-04
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralXttrium Laboratories, Inc.0116-600000116-6000-0400116-6000-16
Chlorhexidine GluconateChlorhexidine gluconate 1.2 mg/mLRinseOralBenco Dental66975-60066975-0600-0466975-0600-16

All 24 Chlorhexidine Gluconate NDCs

Other NDCs under NDA 019258

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

FDA NDC Directory listings under NDA 019258
ProductStrengthForm · routeLabelerProduct NDC
Bactoshield CHGchlorhexidine gluconateChlorhexidine gluconate 20 mg/mLLiquidTopicalSC Johnson Professional USA, Inc.11084-126
Bactoshield CHGchlorhexidine gluconateChlorhexidine gluconate 40 mg/mLLiquidTopicalSC Johnson Professional USA, Inc.11084-128
Halyard Chlorhexidine Gluconatechlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalOwens & Minor, Inc.39892-0960
Halyard Chlorhexidine Gluconatechlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalOwens & Minor, Inc.39892-0961
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalHenry Schein, Inc.0404-0219
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalHenry Schein, Inc.0404-0220
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%chlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalHenry Schein, Inc.0404-0221
Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconateChlorhexidine gluconate 20 mg/mLSolutionTopicalAVA, Inc.42939-124
Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalAVA, Inc.42939-125
Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconateChlorhexidine gluconate 20 mg/mLSolutionTopicalAVA, Inc.42939-127
Scrub, Scrub-Stat, Foam Safe, Micro-Guardchlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalAVA, Inc.42939-128
Scrub-Statchlorhexidine gluconateChlorhexidine gluconate 20 mg/mLSolutionTopicalEcolab Inc.47593-463
Scrub-Statchlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalEcolab Inc.47593-464
Scrub-Statchlorhexidine gluconateChlorhexidine gluconate 20 mg/mLSolutionTopicalEcolab Inc.47593-467
Scrub-Statchlorhexidine gluconateChlorhexidine gluconate 40 mg/mLSolutionTopicalEcolab Inc.47593-468

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