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ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution, 25 pouches — NDC 54365-0400-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution, 25 pouches — NDC 54365-400-35 (Billing 54365-0400-35)

by CareFusion 213, LLC · 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR

This is a package of 25 pouches of ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution from CareFusion 213, LLC, marketed since May 2019 and currently FDA-listed.

NDC 54365-0400-35
🏷️ FDA NDC (as labeled) 54365-400-35 billing pads the product segment with a zero
This package
Contains25 pouches Pack sizes22 compare ↓
Product page 54365-0400-01 Also comes in: 26 mL 54365-400-37 26 mL 54365-400-38 26 mL 54365-400-39 26 mL 54365-400-05 26 mL 54365-400-14 26 mL 54365-400-13 20 pouches 54365-400-30 20 pouches 54365-400-02 25 pouches 54365-400-32 25 pouches 54365-400-33 25 pouches 54365-400-34 25 pouches 54365-400-36 25 pouches 54365-400-04 25 pouches 54365-400-09 25 pouches 54365-400-01 25 pouches 54365-400-11 25 pouches 54365-400-12 40 pouches 54365-400-08 48 pouches 54365-400-07 60 pouches 54365-400-31 60 pouches 54365-400-06
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 54365-400-35 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54365 labeler · 400 product · 35 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5436540035 8
FDA record last changed
Oct 1, 2026
🚨
Active recall for this product.
Class II · Jul 9, 2026 — Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator (CareFusion 213, LLC) · FDA recall D-0690-2026
Lots / codes: Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 51546… · reported Jul 22, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0643-2026
Lots / codes: Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027. · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0645-2026
Lots / codes: Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2… · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0646-2026
Lots / codes: Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028. · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0647-2026
Lots / codes: Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227… · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0648-2026
Lots / codes: Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028. · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0649-2026
Lots / codes: Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028 · reported Jul 8, 2026
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0650-2026
Lots / codes: Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028. · reported Jul 8, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Chlorhexidine Gluconate And Isopropyl Alcohol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 17, 2025 — Lack of Assurance of Sterlity (CareFusion 213, LLC) · FDA recall D-0243-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Aug 25, 2023 · Completed — Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. (CareFusion 213, LLC) · FDA recall D-1168-2023

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54365-400-35
Product NDC 54365-400
11-digit billing NDC 54365040035
RxCUI 858726, 998282
UNII MOR84MUD8E, ND2M416302
Application # NDA020832
SPL Set ID f06e4f9d-6cef-b57a-e053-2a95a90a7337
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-24
Route TOPICAL
Dosage form SOLUTION
Substance CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 064179
GCN 99885
HICL code 010060
Ingredient (HICL) Chlorhexidin/Isopropyl Alcohol
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5B
Therapeutic class — specific (HIC3) Topical Preparations,Antibacterials
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name CHLORAPREP 2%-70% APPLICATOR
FDB brand name Chloraprep Clear
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 064179
  • GCN: 99885
  • HICL (First Databank): 010060
  • AHFS class code: 08:30.04.00
  • RxCUI (RxNorm): 858726
Why two NDCs? The FDA registers this code as 54365-400-35 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 54365-0400-35. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives, Biguanides and amidines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CHLORAPREP 2%-70% APPLICATOR Ingredient Chlorhexidin/Isopropyl Alcohol
📗 Our plain-language guide HelloPharmacist
  • These are professional antiseptic products used to clean your skin right before surgery or an injection. The goal is to kill bacteria on the skin's surface to lower the chance of i...
  • The solution contains alcohol, which is flammable. If any surgical equipment that creates heat or sparks — like cautery or laser tools — is used before the area is fully dry, there...
  • Why does the nurse or surgical tech have to let it dry before the procedure starts?
  • Yes — a severe allergic reaction is possible, though not common. Signs to watch for include wheezing, difficulty breathing, swelling of the face, hives, or rash. If any of those ha...
📖 Read our full Chlorhexidine / Isopropyl Alcohol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 26 mL 26 mL 26 mL 26 mL 26 mL 26 mL 20 pouches 20 pouches 25 pouches 25 pouches 25 pouches 25 pouches 25 pouches 25 pouches 25 pouches 25 pouches 25 pouches 40 pouches 48 pouches 60 pouches 60 pouches
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54365-0400-07 54365-400-07 48 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 2005-05-10 — Active
54365-0400-30 54365-400-30 20 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-31 54365-400-31 60 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-32 54365-400-32 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-33 54365-400-33 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-34 54365-400-34 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-35 You're viewing this 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-36 54365-400-36 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-37 54365-400-37 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-38 54365-400-38 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-39 54365-400-39 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2019-05-24 — Active
54365-0400-05 54365-400-05 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2002-04-26 — Discontinued by firm
54365-0400-14 54365-400-14 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2000-07-14 — Discontinued by firm
54365-0400-13 54365-400-13 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2006-08-18 — Discontinued by firm
54365-0400-04 54365-400-04 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2000-07-14 — Discontinued by firm
54365-0400-09 54365-400-09 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2002-04-26 — Discontinued by firm
54365-0400-01 54365-400-01 Main listing 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR 2000-07-14 — Discontinued by firm
54365-0400-11 54365-400-11 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 3 mL in 1 APPLICATOR 2006-08-18 — Discontinued by firm
54365-0400-12 54365-400-12 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2006-08-18 — Discontinued by firm
54365-0400-06 54365-400-06 60 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1 mL in 1 APPLICATOR 2014-07-23 — Discontinued by firm
54365-0400-02 54365-400-02 20 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.5 mL in 1 APPLICATOR 2002-04-26 — Discontinued by firm
54365-0400-08 54365-400-08 40 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 2009-06-10 — Active

Pack size FAQ

What quantity is in this package?
This package contains 25 pouches — 25 pouch in 1 carton / 1 applicator in 1 pouch / 10.5 ml in 1 applicator.
How does this package differ from NDC 54365-0400-30?
Both are ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution — the drug itself is identical. This page's package is the 25 pouches one, while NDC 54365-0400-30 is the 20 pouches package.
What NDC number is used to bill for this package of ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
3M SoluPrep S 20 mg/mL; .7 mL/mL 17518-0082-01 Solventum 1 applicator — — FDA listed —
3M SoluPrep S 20 mg/mL; .7 mL/mL 17518-0083-02 Solventum 1 applicator — — FDA listed —
ChloraPrep One-Step 20 mg/mL; .7 mL/mLthis 54365-0400-35 CareFusion 25 pouches — — FDA listed —
ChloraPrep Swabstick 20 mg/mL; .7 mL/mL 54365-0401-28 CareFusion 48 pouches — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2000
First FDA approval
Jul 2000
📍
2026
Currently FDA-listed
26 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 14, 2000 RLD RS ⏳ ~0.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7422388 — method of use (U-1397)
US 7422388 — method of use (U-1397)
US 7422388 — method of use (U-1397)
2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 7422388 ↗ Method of use U-1397 Apr 25, 2027
US 7422388 ↗ Method of use U-1397 Apr 25, 2027
US 7422388 ↗ Method of use U-1397 Apr 25, 2027
Common questions
Is there a generic version of CHLORAPREP 2%-70% APPLICATOR?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CHLORAPREP 2%-70% APPLICATOR. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2027 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Chlorhexidine / Isopropyl Alcohol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesUSP purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCareFusion 213, LLC
Application holderBECTON DICKINSON AND CO
FDA applicationNDA020832 (NDA)
Labeler code54365
First marketedMay 2019
Product typeHuman Otc Drug

More NDCs from CareFusion 213, LLC labeler code 54365

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Use for the preparation of the patient's skin prior to surgery or injection. Helps to reduce bacteria that potentially can cause skin infection.

⏱️ Dosage and Administration 162 words ▾

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2 ) tear pouch at side notch to reveal applicator handles.

Do not touch foam applicator tip. Place foam flat side down on the treatment area. completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds.

Do not blot or wipe away. moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute. Do not blot or wipe away. discard the applicator after a single use along with any portion of the solution not required to cover the prep area.

It is not necessary to use the entire amount available.

⚠️ Warnings 195 words ▾

Warnings For external use only. Flammable, keep away from fire or flame. do not use with electrocautery procedures Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.

📦 Storage and Handling 18 words ▾

Other information store between 15-30 ºC (59-86 °F) avoid freezing and excessive heat above 40 ºC (104 °F)

🧪 Active Ingredient 10 words ▾

Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

🧪 Inactive Ingredients 5 words ▾

Inactive ingredient USP purified water

🎯 Purpose 3 words ▾

Purposes Antiseptic Antiseptic

📄 Do Not Use 35 words ▾

Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser

📄 When Using This Product 36 words ▾

When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 9 words ▾

Questions? www.chloraprep.com call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

📄 Package Label / Principal Display Panel 80 words ▾

Package/Label Principal Display Panel PRINCIPAL DISPLAY PANEL-CARTON 1.75ml SINGLE SWABSTICK APPLICATORS Clear Do Not Reuse Not made with natural rubber latex 48 applicators 0.06 fl. oz. (1.75 ml) each NDC 054365-400-07 Cat. No.

2601000 ChloraPrep ® One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation Non-sterile Solution Applicator is non-sterile Professional Use Only Store between 15-30 ºC (59-86 ºF) Avoid freezing and excessive heat above 40 ºC (104 ºF) Single Swabstick carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CareFusion 213, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 21 other package presentations of this same product, including 1 applicator (54365-0400-37), 1 applicator (54365-0400-38), 1 applicator (54365-0400-39). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CareFusion 213, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 54365-0014-41 · CareFusion 54365-0401-28 · CareFusion →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.