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ChloraPrep Swabstick Chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution, 48 pouches — NDC 54365-0401-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ChloraPrep Swabstick Chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution, 48 pouches — NDC 54365-401-28 (Billing 54365-0401-28)

by CareFusion 213 LLC · 48 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR

This is a package of 48 pouches of ChloraPrep Swabstick Chlorhexidine gluconate and isopropyl alcohol 20 mg/mL; .7 mL/mL Solution from CareFusion 213 LLC, marketed since May 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 54365-0401-28
🏷️ FDA NDC (as labeled) 54365-401-28 billing pads the product segment with a zero
This package
Contains48 pouches Pack sizes2 compare ↓
Main listing for product 54365-401 · Also comes in: 40 pouches 54365-401-29
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 54365-401-28 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54365 labeler · 401 product · 28 package
Package marketed since
May 13, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5436540128 7
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Dec 17, 2025 — Lack of Assurance of Sterlity (CareFusion 213, LLC) · FDA recall D-0243-2026
Lots / codes: Lot #: 5086623, Exp. Date 03/31/2028 · reported Jan 7, 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) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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
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-0652-2026
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
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
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-0651-2026
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
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54365-401-28
Product NDC 54365-401
11-digit billing NDC 54365040128
RxCUI 1918214
UNII MOR84MUD8E, ND2M416302
Application # NDA021555
SPL Set ID 1666069b-38f6-bfde-e063-6394a90ad1b8
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 2024-05-13
Route TOPICAL
Dosage form SOLUTION
Substance CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 1918214
Why two NDCs? The FDA registers this code as 54365-401-28 — 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 → 54365-0401-28. 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

📗 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: 40 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
54365-0401-28 You're viewing this Main listing 48 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR 2024-05-13 — Active
54365-0401-29 54365-401-29 40 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 5.25 mL in 1 APPLICATOR 2024-05-13 — Active

Pack size FAQ

What quantity is in this package?
This package contains 48 pouches — 48 pouch in 1 carton / 1 applicator in 1 pouch / 1.75 ml in 1 applicator.
What NDC number is used to bill for this package of ChloraPrep Swabstick 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
ChloraPrep Swabstick 20 mg/mL; .7 mL/mLthis 54365-0401-28 CareFusion 48 pouches — — FDA listed —
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA) 20 mg/mL; .7 mL/mL 84128-0008-03 XINXIANG 1 applicator — — FDA listed —
Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA) 20 mg/mL; .7 mL/mL 84128-0010-01 XINXIANG 1 applicator — — FDA listed —
ChloraPrep One-Step 20 mg/mL; .7 mL/mL 54365-0400-07 CareFusion 48 pouches — — FDA listed —
3M SoluPrep S 20 mg/mL; .7 mL/mL 17518-0083-02 Solventum 1 applicator — — FDA listed —
3M SoluPrep S 20 mg/mL; .7 mL/mL 17518-0082-01 Solventum 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

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 applicationNDA021555 (NDA)
Labeler code54365
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio3 products on file

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 42 words ▾

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

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

⏱️ Dosage and Administration ~2 min read ▾

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 one single swabstick 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 repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 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 repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 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.

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 using three swabsticks sequentially is approximately 5 in. x 5 in. (160 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): using each swabstick sequentially, use repeated back-and-forth strokes for a total of 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): using each swabstick sequentially, use repeated back-and-forth strokes for a total of 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 102 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.

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.

📦 Storage and Handling 36 words ▾

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

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

🧪 Active Ingredient 37 words ▾

BD ChloraPrep™ Single Swabstick 1.75 mL Applicators Active ingredients Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v

BD ChloraPrep™ Triple Swabstick 5.25 mL Applicators Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

🧪 Inactive Ingredients 10 words ▾

Inactive ingredient USP purified water

Inactive ingredient USP purified water

🎯 Purpose 5 words ▾

Purpose Antiseptic

Purposes Antiseptic Antiseptic

📄 Do Not Use 70 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

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 72 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.

When using this product keep out of eyes, ears, and mouth. May cause serious or permanent inury 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 42 words ▾

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

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 38 words ▾

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

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

📄 Questions or Comments 18 words ▾

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

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

📄 Package Label / Principal Display Panel 105 words ▾

BD ChloraPrep™ Single Swabstick Package/Label Principal Display Panel PRINCIPAL DISPLAY PANEL-CARTON BD ChloraPrep™ Single Swabstick Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 1.75 mL Applicators NDC 054365-401-28 Ref 930100 Foil Pouch Front-Single Swabstick Foil Pouch Back-Single Swabstick Carton - Single Swabstick

BD ChloraPrep™ Triple Swabsticks Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v Swab Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact 5.25 mL Applicators NDC 54365-401-29 REF 930103 Foil Pouch front-Triple Swabsticks Foil Pouch Back-Triple Swabsticks Carton-Triple Swabsticks

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ChloraPrep Swabstick (this brand).

Top reported reactions

Hand Deformity16
Helicobacter Infection16
Rheumatoid Arthritis16
Swelling16
Systemic Lupus Erythematosus16
Glossodynia15
Infusion Related Reaction15

Reporter sex

20 reports

Serious outcomes

Hospitalization18
Disabling18
Life-threatening14
Death11
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 9 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 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 1 other package presentation of this same product, including 40 pouches (54365-0401-29). 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.
← 54365-0400-07 · CareFusion 54382-0112-01 · CU →
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.