HomeNDC LookupIngredientsChlorhexidine Gluconate 2% › 53329-0244-03
ReadyPrep CHG Chlorhexidine gluconate 2% 500 mg Cloth, 6-count — NDC 53329-0244-03 package photo

ReadyPrep CHG Chlorhexidine gluconate 2% 500 mg Cloth, 6-count

by Medline Industries, LP · 6 CLOTH in 1 POUCH (53329-244-03)
NDC 53329-0244-03
🏷️ FDA NDC (as labeled) 53329-244-03 billing pads the product segment with a zero
This package
Contains6-count Pack sizes3 compare ↓
OTC Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 53329-244-03
Product NDC 53329-244
11-digit billing NDC 53329024403
RxCUI 846127
UNII MOR84MUD8E
Application # NDA207964
SPL Set ID 458cf999-5e3d-4d4d-82d5-02118c331893
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 2019-01-14
Route TOPICAL
Dosage form CLOTH
Substance CHLORHEXIDINE GLUCONATE
GCN Seq No 063166
GCN 98923
HICL code 004297
Ingredient (HICL) Chlorhexidine Gluconate
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 READYPREP CHG 2% CLOTH
FDB brand name Readyprep Chg
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 53329-244-03 — 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 → 53329-0244-03. 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.

🏭 Manufacturer & labeler

LabelerMedline Industries, LP
Application holderMEDLINE INDUSTRIES INC
FDA applicationNDA207964 (NDA)
Labeler code53329
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio118 products on file
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.

🩺 Clinical

Label name READYPREP CHG 2% CLOTH Ingredient Chlorhexidine Gluconate
📗 Our plain-language guide HelloPharmacist
  • It's actually a prescription-strength antimicrobial rinse, which is different from over-the-counter mouthwash. Your dentist prescribes it specifically to treat gingivitis — that's...
  • What exactly is chlorhexidine rinse for — is it just like a regular mouthwash?
  • Yes, tooth and surface staining is one of the most common side effects of chlorhexidine oral rinse. It can also increase tartar buildup on your teeth. The good news is that this is...
  • My teeth look like they're staining — is that from the rinse?
📖 Read our full Chlorhexidine guide →
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.

🧪 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.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 2Y53S6ATLU
    Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbenzalkonium chloride dimethicone emulsion glycerin isopropyl alcohol propylene glycol purified water USP

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 DailyMedingredient 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.

💲 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 eachPer 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: 2 cloths 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ReadyPrep CHG 500 mgthis 53329-0244-03 Medline 6 cloths FDA listed
Chlorhexidine Gluconate 500 mg 53462-0705-20 Sage 2 cloths FDA listed
Swab Stick 2% w/w chlorhexidine gluconate (CHG) 20 mg/mL 84128-0011-01 XINXIANG 1 applicator 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53329-0244-01 2 CLOTH in 1 POUCH (53329-244-01) 2019-01-14 Active
53329-0244-02 24 POUCH in 1 CARTON (53329-244-02) / 2 CLOTH in 1 POUCH (53329-244-01) 2019-01-14 Active
53329-0244-03 You're viewing this 6 CLOTH in 1 POUCH (53329-244-03) 2022-12-01 Active

Pack size FAQ

What quantity is in NDC 53329-0244-03?
NDC 53329-0244-03 is a 6-count package — 6 cloth in 1 pouch.
What is the difference between NDC 53329-0244-03 and NDC 53329-0244-01?
Both are ReadyPrep CHG Chlorhexidine gluconate 2% 500 mg Cloth — the drug itself is identical. NDC 53329-0244-03 is the 6-count package, while NDC 53329-0244-01 is the 2 cloths package.
What NDC number is used to bill for this package of ReadyPrep CHG Chlorhexidine gluconate 2% 500 mg Cloth?
Bill NDC 53329-0244-03 — the 11-digit billing format is 53329024403. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 53329-244-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53329-0244-03, written without dashes as 53329024403. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53329-0244-03, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0244) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Medline Industries, LP. 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 2 other package presentations of this same product, including 2 cloths (53329-0244-01), 24 pouches (53329-0244-02). 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?
Medline Industries, LP 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.

📄 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 17 words

Uses helps reduce bacteria that can potentially cause skin infection for preparation of skin prior to surgery

⏱️ Dosage and Administration ~1 min read

Directions use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. do not microwave product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products. to open package : identify the tear notch labeled on the front of the package.

Grasp with both hands on both sides of the tear notch and tear to expose cloth. transfer contents onto prep table, avoiding contact between cloth and outside of package to reduce risk of cloth contamination use [first/a] cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the [second/remaining] cloth[s] where it will not be contaminated. Use [second/additional] cloth to prepare larger areas. dry surgical sites : (such as abdomen or arm): use one cloth to cleanse each 161 cm 2 area (approximately) 5 x 5 inches) of skin to be prepared.

Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse. moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm 2 area (approximately 2 x 5 inches) of skin to be prepared.

Vigorously scrub skin back and forth for 3 minutes, competely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse. discard each cloth after a single use after package has been opened, discard any unused cloths

⚠️ Warnings 183 words

Warnings For external use only 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 punctures or in contact with the meninges on open skin wounds as a general skin cleanser Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition. When using this product keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain.

If contact occurs, rinse with cold water right away and contact a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Posion 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.

🧪 Active Ingredient 6 words

Active ingredient Chlorhexidine gluconate 2% solution

🧪 Inactive Ingredients 14 words

Inactive ingredients benzalkonium chloride dimethicone emulsion glycerin isopropyl alcohol propylene glycol purified water USP

🎯 Purpose 2 words

Purpose Antiseptic

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