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Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid, 500 mL — NDC 63002-0002-50 package photo

Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid, 500 mL

by Advanced Hygienics LLC · 500 mL in 1 BOTTLE (63002-002-50)
NDC 63002-0002-50
🏷️ FDA NDC (as labeled) 63002-002-50 billing pads the product segment with a zero
This package
Contains500 mL Pack sizes4 compare ↓
Also comes in: 50 ml 63002-0002-99 1250 ml 63002-0002-12 9463 ml 63002-0002-75
OTC 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Benzalkonium Chloride (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 · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63002-002-50
Product NDC 63002-002
11-digit billing NDC 63002000250
RxCUI 1020365
UNII F5UM2KM3W7
Application # part333A
SPL Set ID 09edbc17-c443-4b0d-9c28-c4b8233c4d1a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-05-02
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 63002-002-50 — 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 → 63002-0002-50. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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

LabelerAdvanced Hygienics LLC
FDA applicationpart333A (OTC MONOGRAPH NOT FINAL)
Labeler code63002
First marketedMay 2014
Product typeHuman Otc Drug
Portfolio2 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

🧪 What is this product?

This is a topical hand sanitizer liquid containing benzalkonium chloride, an antimicrobial agent typically used to reduce bacteria and other microorganisms on the skin. It is marketed as an over-the-counter product under FDA's monograph rules for hand sanitizers, rather than as an individually approved drug application. Benzalkonium chloride functions as a disinfectant commonly found in hand sanitizers, skin antiseptics, and wound-cleaning products.

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 3XY03A79QH
    A synthetic surfactant derived from fatty alcohols, used to help dissolve, suspend, or blend oils and water-based ingredients in liquid formulations. It improves the uniform mixing and stability of the medicine.
  • UNII V109WUT6RL
    Caprylyl glucoside is a gentle, plant-derived cleanser made from coconut and glucose. It's used in medicines as a surfactant and emulsifier to help mix oil and water-based ingredients together.
  • UNII UC9PE95IBP
    A synthetic compound that works as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the shelf life of liquid formulations like eye drops and topical solutions.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 8AR51R3BL5
    A cleaning agent derived from coconut oil, used as a surfactant and emulsifier to help mix oil and water-based ingredients together in liquid formulations.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 3057VPT0KC
    A plant-based emulsifier derived from coconut oil and glycerin. It helps blend oil and water components together in formulations and improves texture and spreadability of topical products.
  • UNII A81MSI0FIC
    A quaternary ammonium compound derived from lauryl alcohol. It acts as an antimicrobial preservative and antistatic agent to help keep the product stable and prevent microbial growth during storage.
  • UNII 322U039GMF
    Polihexanide is a synthetic antimicrobial chemical used as a preservative in some liquid medications and topical products. It prevents bacterial and fungal growth to maintain product safety during storage and use.
  • 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.

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

The official label also statesInactive ingredients: Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

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.

💲 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: 50 ml 1250 ml 9463 ml
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
Instant Foam Non-alcohol PURE Hand Sanitizer .13 g/100mL 11084-0300-01 SC 47 ml — — Discontinued —
Foaming Hand 1.3 mg/mL 11344-0224-04 Nice-Pak 750 ml — — Discontinued —
Benzalkonium chloride 1.3 mg/mL 11673-0681-23 Target 68 ml — — FDA listed —
QS Plus Instant Hand Sanitizer 1.3 mg/mL 13302-0457-10 Romaine 1000 ml — — Discontinued —
X3 Clean 1.3 mg/mL 26550-0001-12 X3 75 ml — — FDA listed —
Tork Hand Sanitizer Alcohol Free Foam .13 g/100mL 49351-0103-01 Essity 6 bottles — — FDA listed —
Tork Hand Sanitizing Alcohol-Free Foam 1.3 mg/mL 49351-0303-01 Essity 1000 ml — — FDA listed —
X3 Clean Foaming Hand Sanitizer 1.3 mg/mL 49354-0055-75 HK 75 ml — — FDA listed —
Ben E. Keith FIHS 1.3 mg/mL 50980-0207-12 Ben 1000 ml — — FDA listed —
American Red Cross Antiseptic Cleansing Foam .13 g/100mL 51628-4539-01 MY 177 ml — — FDA listed —
North Woods Derma Foam Hand Sanitizer 1.3 mg/mL 53125-0700-54 Superior 1000 ml — — Discontinued —
DermaCen Non-Alcohol Foaming Hand Sanitizer .13 g/100mL 62654-0141-14 Central 532 ml — — FDA listed —
Byotrol Hand Sanitizer 1.3 mg/mLthis 63002-0002-50 Advanced 500 ml — — FDA listed —
Hand Sanitizer 1.3 g/mL 63002-0004-33 Advanced 9.76 ml — — FDA listed —
99 Plus Hand Sanitizer 1.3 mg/mL 63533-0457-10 Momar 1000 ml — — FDA listed —
Lite nFoamy Eucalyptus Mint Sanitizing Handwash 1.3 g/L 64009-0332-72 Spartan 532 l — — FDA listed —
Lite nFoamy E2 Sanitizing Handwash 1.3 g/L 64009-0333-95 Spartan 3.79 l — — FDA listed —
Enriched Foam Alcohol-Free Hand Sanitizer 13 mg/100mL 65321-0039-01 Rubbermaid 4 pouches — — FDA listed —
Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 65601-0700-04 Betco 3780 ml — — FDA listed —
Band Aid Antiseptic Cleansing 1.3 mg/mL 69968-0728-01 Kenvue 68 ml — — FDA listed —
Blue Green Foam .13 g/100mL 70411-0100-07 H2Ocean, 207 ml — — FDA listed —
ElimiShield Hunt Core Body Foam for Hunters 1.3 mg/mL 71853-0010-00 Bryson 200 ml — — FDA listed —
Germ Free 24 Hand Sanitizer 1.3 mg/mL 71884-0006-01 Enviro 50 ml — — FDA listed —
Doctor Inks Hand Sanitizer 1.3 mg/mL 71884-0201-01 Enviro 58 ml — — FDA listed —
Mountain Air Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0040-08 K7 236 ml — — FDA listed —
Pine and Honey Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0041-08 K7 236 ml — — FDA listed —
Simply Lavender Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0042-08 K7 236 ml — — FDA listed —
Vanilla Coconut Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0043-16 K7 473 ml — — FDA listed —
Foaming Hand Sanitizer 1.3 g/1000mL 75044-0280-16 American 2 bottles — — FDA listed —
American Red Cross Antiseptic Cleansing Foam .13 g/100mL 75742-0082-01 Zhejiang 177 ml — — FDA listed —
Hand Sanitizer .13 g/100mL 76370-0006-05 Tazza 1000 ml — — Discontinued —
Gentlecare Hand And Skin Sanitizer 1.3 mg/mL 78181-0020-02 PARAGON 50 ml — — FDA listed —
KleenLine Essentials Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 79258-0700-29 Brady 1000 ml — — FDA listed —
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0004-01 USA 237 ml — — FDA listed —
Hygiene Clean Leather Oak Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0005-01 USA 237 ml — — FDA listed —
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0006-01 USA 237 ml — — FDA listed —
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0007-01 USA 237 ml — — FDA listed —
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0025-08 USA 237 ml — — FDA listed —
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0026-08 USA 237 ml — — FDA listed —
Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0027-08 USA 237 ml — — FDA listed —
Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0100-01 USA 800 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0101-01 USA 800 ml — — FDA listed —
Hygiene Clean Luxury Clean Hand Sanitizer 1.3 mg/mL 80499-0102-01 USA 800 ml — — FDA listed —
Antiseptic Foaming Hand Sanitizer 1.3 mg/mL 82442-0812-20 Target 2 bottles — — FDA listed —
NOxyDERM .13 g/100mL 83823-0001-01 NOxy 100 ml — — FDA listed —
NOxyDERM .038 g/29.5mL 83823-0002-01 NOxy 29.5 ml — — FDA listed —
Foaming Hand Sanitizer 1.3 mg/mL 83986-0118-45 UpLift 1150 ml — — FDA listed —
Guardelle .13 g/100mL 85754-0000-02 Social 52 ml — — FDA listed —
GrowDefender Antibacterial Foam 1.3 mg/mL 87109-0013-01 Grow 50.68 ml — — FDA listed —
Harris Teeter Spring Fresh Body Wash 1.3 mg/mL 72036-0801-18 Harris 532 ml — — FDA listed —
HUMCO Merthiolate 1.3 mg/mL 00395-8010-92 Humco 59 ml — — FDA listed —
Tincture Merthiolate 1.3 mg/mL 24286-1532-07 DLC 30 ml — — FDA listed —
Tri-Soft Softening 1.3 mg/mL 44577-0711-08 Clinical 236.59 ml — — FDA listed —
Quality Choice Merthiolate 1.3 mg/mL 63868-0493-02 Chain 59 ml — — FDA listed —
CVS Merthiolate 1.3 mg/mL 69842-0749-92 CVS 59 ml — — FDA listed —
ElimiShield Home and Outdoor Moisturizing Hand Sanitizer 1.3 mg/mL 71853-0006-01 Bryson 50 ml — — FDA listed —
Inofoam Antibacterial Foaming Hand Wash 1.3 mg/mL 73062-0032-01 Avro 1 bottle — — FDA listed —
Inofoam Antibacterial Foaming Hand Wash 1.3 mg/mL 73062-0033-01 Avro 1000 ml — — FDA listed —
Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0001-01 USA 237 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0002-01 USA 237 ml — — FDA listed —
Hygiene Clean Unscented Hand Sanitizer 1.3 mg/mL 80499-0003-01 USA 237 ml — — FDA listed —
Hygiene Clean Pumpkin Spice Hand Sanitizer 1.3 mg/mL 80499-0008-01 USA 50 ml — — FDA listed —
Hygiene Clean Blueberry Lemonade Hand Sanitizer 1.3 mg/mL 80499-0009-01 USA 50 ml — — FDA listed —
Hygiene Clean Leather Oak Hand Sanitizer 1.3 mg/mL 80499-0010-01 USA 50 ml — — FDA listed —
Hygiene Clean Mahogany Teakwood Hand Sanitizer 1.3 mg/mL 80499-0011-01 USA 50 ml — — FDA listed —
Hygiene Clean Bubble Gum Hand Sanitizer 1.3 mg/mL 80499-0012-01 USA 50 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0013-01 USA 50 ml — — FDA listed —
Hygiene Clean Unscented Clean Hand Sanitizer 1.3 mg/mL 80499-0014-01 USA 50 ml — — FDA listed —
Hygiene Clean Balsam Fir Hand Sanitizer 1.3 mg/mL 80499-0015-01 USA 50 ml — — FDA listed —
Hygiene Clean Blueberry Lemonade Hand Sanitizer Car Safe Alcohol-Free 1.3 mg/mL 80499-0017-00 USA 237 ml — — FDA listed —
Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol Free 1.3 mg/mL 80499-0018-00 USA 237 ml — — FDA listed —
Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0030-01 USA 50 ml — — FDA listed —
Hygiene Clean Luxury Clean hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0031-01 USA 50 ml — — FDA listed —
Hygiene Clean Lavender Blossom Hand Sanitizer 1.3 mg/mL 80499-0103-01 USA 50 ml — — FDA listed —
Hygiene Clean Lilac Garden Hand Sanitizer 1.3 mg/mL 80499-0104-01 USA 50 ml — — FDA listed —
Hygiene Clean Spring Bloom Hand Sanitizer 1.3 mg/mL 80499-0105-01 USA 50 ml — — FDA listed —
Merthiolate 1.3 mg/mL 82645-0912-92 Pharma 59 ml — — FDA listed —
TopCare Antibacterial Hand Fresh and Clean 1.3 mg/mL 36800-0534-56 Topco 1656 ml — — FDA listed —
Dalan Therapy Antibacterial Hand Wash, Active Protection 1.3 mg/mL 51209-0014-00 DALAN 300 ml — — FDA listed —
Covex Antibacterial Liquid Hand Wash Cool Protection 1.3 mg/mL 51209-0031-03 DALAN 300 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 55319-0633-03 Family 1470 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 62832-0628-96 S. 221 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 75712-0575-96 Old 221 ml — — FDA listed —
FoamFresh E-2 Sanitizer Cleanser 1.3 mg/mL 11429-1002-00 Woodbine 1125 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41250-0628-45 Meijer, 946 ml — — FDA listed —
Covex Antibacterial Hand Wash Active Protection 1.3 mg/mL 51209-0030-03 DALAN 300 ml — — FDA listed —
Cold Sore Treatment, 24-7 Life by 7-Eleven 1.3 mg/mL 66715-5189-00 Lil' 1 bottle — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0001-16 Sante 500 ml — — FDA listed —
Hand Wash 1.3 mg/mL 79903-0163-32 Walmart 946 ml — — FDA listed —
MK BZK Antiseptic Towelette Non-Sterile 1.3 mg/mL 59050-0331-20 Changzhou 100 pouches — — Discontinued —
Hand Wash 1.3 mg/mL 57243-0001-96 Salado 221 ml — — FDA listed —
RELEEV Cold Sore Treatment 1.3 mg/mL 63287-0419-01 Merix 1 pouch — — FDA listed —
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent 1.3 mg/mL 78691-0022-00 Quest 40 patches — — FDA listed —
Harbor Mist E2 Sanitizing Foam with BZK 1.3 mg/mL 81792-0004-01 Von 1250 ml — — FDA listed —
First Aid Only BZK Antiseptic Towelettes 1.3 mg/mL 00924-7115-00 Acme 1.6 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41163-0628-45 United 946 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41250-0661-45 Meijer, 946 ml — — Discontinued —
Dalan Therapy Antibacterial Hand Wash, Fresh Protection 1.3 mg/mL 51209-0016-00 DALAN 300 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 55319-0792-03 Family 1470 ml — — FDA listed —
Antibacterial Foaming Hand Wash 1.3 mg/mL 57243-0628-96 Salado 221 ml — — FDA listed —
KIMBALL MIDWEST Antibacterial Hand Cleaner 1.3 mg/mL 66608-0216-01 Kimball 3785 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0003-32 Sante 947 ml — — FDA listed —
Antibacterial 2X 1.3 mg/mL 71020-0005-02 Sante 2 bottles — — FDA listed —
Antibacterial 2X 1.3 mg/mL 71020-0016-16 Sante 500 ml — — FDA listed —
Biopure Pocket Size Singles Fresh Breeze Scent 1.3 mg/mL 78691-0024-00 Quest 16 packets — — FDA listed —
El Valle Merthiolate 1.3 mg/mL 55758-0375-02 Pharmadel 30 ml — — FDA listed —
E-2 Food Processing Foam Hand Wash 1.3 mg/mL 63039-1002-03 Chemco 1000 ml — — FDA listed —
Biopure Anti-bacterial Hand Wipes Honey Wildflower Scent 1.3 mg/mL 78691-0023-00 Quest 40 patches — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 11344-0628-45 Nice-Pak 946 ml — — FDA listed —
Dalan Therapy Antibacterial Hand Wash, Cool Protection 1.3 mg/mL 51209-0015-00 DALAN 300 ml — — FDA listed —
Hand Wash 1.3 mg/mL 55910-0628-45 Old 946 ml — — FDA listed —
Antibacterial Aqua Clear 2X Ultra 1.3 mg/mL 71020-0030-30 Sante 600 ml — — FDA listed —
Hand Wash 1.3 mg/mL 70616-0628-96 Permatex 221 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0004-64 Sante 1900 ml — — FDA listed —
Antibacterial 1.3 mg/mL 76162-0279-03 Topco 1478 ml — — FDA listed —
Novex Hand Sanitizer 1.3 mg/mL 66902-0037-25 Natural 225 ml — — FDA listed —
Covex Antibacterial Hand Wash Fresh Protection 1.3 mg/mL 51209-0032-03 DALAN 300 ml — — FDA listed —
Hand Wash 1.3 mg/mL 53942-0466-45 Demoulas 946 ml — — Discontinued —
X3 Clean Hand Sanitizer 1.3 mg/mL 66902-0038-02 Natural 59 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 68016-0866-45 Pharmacy 946 ml — — FDA listed —
Walgreens Advanced Wound Wash 1.3 mg/mL 00363-9656-10 Walgreens 1 bottle — — FDA listed —
Antibacterial 2X Ultra cleansing 1.3 mg/mL 71020-0020-19 Sante 1900 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0021-32 Sante 947 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 75712-0416-96 Old 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0321-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0317-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0273-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0346-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0373-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0094-45 H 946 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0290-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0252-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0149-45 H 946 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0306-96 H 221 ml — — FDA listed —
Mercurochrome 1.3 mg/mL 69469-0013-01 Vitamex 30 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2014
On the market since
May 2014
📍
2026
Currently FDA-listed
12 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.

🔬 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 Byotrol Hand Sanitizer (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization175
Life-threatening27
Death25
Disabling18
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 24 5
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63002-0002-12 1250 mL in 1 BOTTLE (63002-002-12) 2014-06-25 Active
63002-0002-50 You're viewing this 500 mL in 1 BOTTLE (63002-002-50) 2014-06-25 Active
63002-0002-75 9463 mL in 1 BOTTLE (63002-002-75) 2015-04-01 Active
63002-0002-99 50 mL in 1 BOTTLE (63002-002-99) 2014-05-02 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63002-0002-50?
NDC 63002-0002-50 contains 500 mL — 500 ml in 1 bottle.
What is the difference between NDC 63002-0002-50 and NDC 63002-0002-99?
Both are Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid — the drug itself is identical. NDC 63002-0002-50 is the 500 mL package, while NDC 63002-0002-99 is the 50 ml package.
What NDC number is used to bill for this package of Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE 1.3 mg/mL Liquid?
Bill NDC 63002-0002-50 — the 11-digit billing format is 63002000250. 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Not Final". Products approved under an application carry an NDA, ANDA, or BLA number.
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 63002-002-50, 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: 63002-0002-50, written without dashes as 63002000250. 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 63002-0002-50, the first segment (63002) is the labeler code FDA assigned to Advanced Hygienics LLC; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Advanced Hygienics 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 3 other package presentations of this same product, including 50 ml (63002-0002-99), 1250 ml (63002-0002-12), 9463 ml (63002-0002-75). 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?
Advanced Hygienics 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

⏱️ Dosage and Administration 23 words ▾

Directions Pump a small amount of foam onto hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

⚠️ Warnings 61 words ▾

Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients: Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

🎯 Purpose 2 words ▾

Purpose Antimicrobial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62993-0810-01 · Morepen 63002-0004-33 · Advanced →
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.