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Benzalkonium Chloride 1.3 mg/mL Gel, 1470 mL — NDC 55319-0879-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzalkonium Chloride 1.3 mg/mL Gel, 1470 mL — NDC 55319-879-03 (Billing 55319-0879-03)

by Family Dollar Stores, Inc · 1470 mL in 1 BOTTLE, PLASTIC

This is a package of 1,470 mL of Benzalkonium Chloride 1.3 mg/mL Gel from Family Dollar Stores, Inc, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 55319-0879-03
🏷️ FDA NDC (as labeled) 55319-879-03 billing pads the product segment with a zero
OTC 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

⚠️
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-0374-2026
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) 55319-879-03
Product NDC 55319-879
11-digit billing NDC 55319087903
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID c4328104-5a17-4673-925b-3d3206994e6e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-03
Route TOPICAL
Dosage form GEL
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 55319-879-03 — 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 → 55319-0879-03. 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.

Clinical

🧪 What is this product?

This is a topical gel containing benzalkonium chloride, an antimicrobial agent commonly used in over-the-counter skin care and first-aid products. Benzalkonium chloride functions as a disinfectant and preservative that is typically applied directly to the skin to help reduce bacteria. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this ingredient category rather than undergoing individual review.

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 gPer 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.
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
55319-0879-03 You're viewing this Main listing 1470 mL in 1 BOTTLE, PLASTIC 2025-06-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
North Woods Derma Foam Hand Sanitizer 1.3 mg/mL 53125-0700-54 Superior 1000 ml — — Discontinued —
WIPE OUT Antibacterial Wipes, Lemon Scent 1.3 mg/mL 34645-0009-01 Jianerkang 20 patches — — FDA listed —
WIPE OUT Antibacterial Wipes, Fresh Scent 1.3 mg/mL 34645-0010-01 Jianerkang 20 patches — — FDA listed —
Antibacterial FoamSoap 1.3 mg/mL 84194-0751-29 Ferguson 1000 ml — — FDA listed —
Antibacterial Hand Wipes 1.3 mg/mL 44119-0012-01 Peachtree 80 patches — — Discontinued —
Medi-First Plus Antiseptic Wipes 1.3 mg/mL 47682-0030-71 Unifirst 20 packets — — FDA listed —
Tork Hand Washing Antibacterial Foam 1.3 mg/mL 49351-0304-01 Essity 1000 ml — — FDA listed —
Pacific Blue Ultra Antimicrobial Pacific Citrus 1.3 mg/mL 54622-0712-01 Georgia-Pacific 1200 ml — — FDA listed —
Antibacterial Hand Wipes Lil Drug Store 1.3 mg/mL 66715-6863-00 Lil' 30 applicators — — FDA listed —
Dealmed BZK Antiseptic Towelettes 1.3 mg/mL 70082-0012-01 Dealmed 100 pouches — — FDA listed —
Biopure Antibacterial Hand Wipe Juicy Watermelon 1.3 mg/mL 78691-0034-00 Quest 50 ml — — FDA listed —
Antiseptic Wipe 1.3 mg/mL 83165-0002-00 Hubei 1 patch — — FDA listed —
Pacific Blue Ultra 1.3 mg/mL 54622-0572-01 Georgia-Pacific 1200 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mLthis 55319-0879-03 Family 1470 ml — — FDA listed —
I.C. Waterless Hand Cleaner with Micro Scrubbers 1.3 mg/mL 59555-0303-04 R 59 ml — — FDA listed —
Antibacterial Bathing 1.3 mg/mL 63517-0210-22 Cardinal 8 patches — — FDA listed —
Germ Free Topical Antiseptic 1.3 mg/mL 71884-0008-02 Enviro 57 ml — — FDA listed —
Biopure Antibacterial Hand Wipe Berry Strawberry 1.3 mg/mL 78691-0035-00 Quest 50 ml — — FDA listed —
Transcend E2 Sanitizing Foam 1.3 mg/mL 81792-0002-01 Von 1250 ml — — FDA listed —
Foaming Hand 1.3 mg/mL 83986-0224-08 UpLift 3785 ml — — FDA listed —
HEALTH E Alcohol-Free Antiseptic 1.3 mg/mL 42326-0090-01 Petra 1000 patches — — FDA listed —
Ultra Blue Antibacterial Foaming Skin Cleanser 1.3 mg/mL 65601-0759-03 Betco 750 ml — — FDA listed —
BZK Pads 1.3 mg/mL 67777-0243-03 Dynarex 100 packets — — FDA listed —
Wipex Sanitizing Wipes 1.3 mg/mL 74680-0231-75 Unico 960 ml — — FDA listed —
Antibacterial 1.3 mg/mL 75712-0897-03 Old 1478 ml — — FDA listed —
Wipe Those Hands 1.3 mg/mL 78091-0251-02 Mighty 20 applicators — — FDA listed —
Moisturizing Antibacterial 1.3 mg/mL 79903-0164-11 Walmart 332 ml — — FDA listed —
Antibacterial Hand Wash Spring Rain 1.3 mg/mL 83986-0012-32 UpLift 355 ml — — FDA listed —
Antibacterial Hand Wash 1.3 mg/mL 83986-0015-32 UpLift 355 ml — — FDA listed —
Foaming Hand 1.3 mg/mL 11344-0224-04 Nice-Pak 750 ml — — Discontinued —
Three Cleansing 1.3 mg/mL 34645-0025-01 Jianerkang 500 pouches — — FDA listed —
enMotion Antimicrobial with Moisturizers, Tranquil Aloe 1.3 mg/mL 54622-0700-01 Georgia-Pacific 1200 ml — — FDA listed —
I.C. Antibacterial Hand Cleaner 1.3 mg/mL 59555-0701-08 R 236 ml — — FDA listed —
BZK Pads 1.3 mg/mL 67777-0245-02 Dynarex 1000 packets — — FDA listed —
Hand Wash 1.3 mg/mL 69790-0466-96 ULINE 221 ml — — FDA listed —
My-Shield Topical Antiseptic 1.3 mg/mL 71884-0025-01 Enviro 30 ml — — FDA listed —
Biopure Antibacterial Hand Wipe 1.3 mg/mL 78691-0017-00 Quest 50 patches — — Discontinued —
Club Wipes Alcohol Free Antimicrobial Cleaning Wipes 1.3 mg/mL 42326-0098-01 Petra 1200 patches — — FDA listed —
Foaming Hand 1.3 mg/mL 42961-0224-71 Cintas 800 ml — — FDA listed —
Genuine First Aid Antiseptic Towelette 1.3 mg/mL 50814-0057-01 GFA 225 ml — — FDA listed —
Hand Wash 1.3 mg/mL 71897-0466-86 Veritiv 1000 ml — — FDA listed —
OP First Aid Series Antiseptic Wipe 1.3 mg/mL 72459-0011-01 Yiwu 1 patch — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 79903-0167-50 Walmart 1470 ml — — FDA listed —
Hand Wash 1.3 mg/mL 83986-0460-04 UpLift 750 ml — — FDA listed —
Antibacterial Cherry Blossom 1.3 mg/mL 83986-0913-32 UpLift 355 ml — — FDA listed —
Antiseptic Wipe 1.3 mg/mL 34645-0024-01 Jianerkang 400 pouches — — FDA listed —
Antibacterial 1.3 mg/mL 41250-0976-68 Meijer, 1656 ml — — Discontinued —
BZK Towelette 1.3 mg/mL 65517-0004-01 Dukal 1.4 ml — — FDA listed —
Foaming Hand 1.3 mg/mL 71897-0224-86 Veritiv 1000 ml — — FDA listed —
Thompson Antiseptic 1.3 mg/mL 73408-0035-50 Thompson 50 packets — — FDA listed —
Max OUT 1.3 mg/mL 74680-0221-88 Unico 480 ml — — FDA listed —
Antibacterial Hand White Tea and Eucalyptus 1.3 mg/mL 83986-0140-32 UpLift 355 ml — — FDA listed —
White Rain Antibacterial Hand Fresh and Clean 1.3 mg/mL 52862-0627-00 International 221 ml — — Discontinued —
BZK Pads 1.3 mg/mL 67777-0244-01 Dynarex 100 packets — — FDA listed —
Doctor Inks Topical Antiseptic 1.3 mg/mL 71884-0203-01 Enviro 30 ml — — FDA listed —
Moisturizing Antibacterial 1.3 mg/mL 79903-0165-50 Walmart 1470 ml — — FDA listed —
Petra Health E Wipes Alcohol Free Antiseptic 1.3 mg/mL 42326-0100-01 Petra 1 patch — — FDA listed —
Green Guard Antideptic Wipes 1.3 mg/mL 47682-0055-73 Uniforst 25 packets — — FDA listed —
North Woods Derma Foam E-2 1.3 mg/mL 53125-0817-29 Superior 1000 ml — — FDA listed —
Thompson Antiseptic 1.3 mg/mL 73408-0034-50 Thompson 50 packets — — FDA listed —
Biopure Antibacterial Hand Wipe Vallina Dream 1.3 mg/mL 78691-0036-00 Quest 50 ml — — FDA listed —
Moisturizing Antibacterial 1.3 mg/mL 79903-0166-50 Walmart 1470 ml — — FDA listed —
Mentholatum Moisturizing Hand Sanitizer 1.3 mg/mL 10742-0004-01 The 192 ml — — FDA listed —
Green Guard Antiseptic Wipes 1.3 mg/mL 47682-0075-73 UniFirst 25 packets — — FDA listed —
White Rain Antibacterial Hand Spring Water 1.3 mg/mL 52862-0626-00 International 221 ml — — Discontinued —
enMotion Antimicrobial with Moisturizers, Fragrance Free 1.3 mg/mL 54622-0703-01 Georgia-Pacific 1200 ml — — FDA listed —
Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 65601-0700-04 Betco 3780 ml — — FDA listed —
Zest Antibacterial Liquid Hand Soap, Fresh Aqua 1.3 mg/mL 81277-0013-01 Sodalis 221 ml — — Discontinued —
I.C. Sanitizer and Re-Moisturizer with Benzalkonium Chloride 1.3 mg/mL 59555-0903-03 R 50 ml — — FDA listed —
E2 Antibacterial Foaming Skin Cleanser 1.3 mg/mL 65601-0817-04 Betco 3780 ml — — FDA listed —
VLITEPRO BZK Antiseptic Towelette 1.3 mg/mL 72459-0020-01 Yiwu 1 pouch — — FDA listed —
Fresh Theory Antibacterial Hand Wipes - Peach Prosecco 1.3 mg/mL 78691-0039-00 Quest 40 ml — — FDA listed —
Fresh Theory Antibacterial Hand Wipes Fresh And Fruity 1.3 mg/mL 78691-0038-00 Quest 40 ml — — FDA listed —
Fresh Theory Antibacterial Hand Wipes - Tropical Escape 1.3 mg/mL 78691-0040-00 Quest 40 ml — — FDA listed —
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, Fresh 1.3 mg/mL 78691-0041-01 Quest 3 canisters — — FDA listed —
B-Pure Antibacterial Wipes for Hands and Face Vitamin E and Aloe 1.3 mg/mL 80684-0233-01 Fourstar 70 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

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

  • 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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 5365FJ30SC
    A synthetic emulsifier and surfactant derived from stearic acid. It helps mix water and oil-based ingredients together and improves product texture and stability in lotions, creams, and other formulations.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 I6KX160QTV
    A cleaning agent and surfactant derived from coconut oil. It helps reduce foam and improves the flow and mixing of powder ingredients in the formulation.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • UNII 3HSF539C9T
    A surfactant and foaming agent derived from myristic acid. It helps mix oil and water-based ingredients, improves product texture, and aids in even distribution of active ingredients throughout the formulation.
  • UNII 6F36Q0I0AC
    PEG-150 distearate is a waxy substance made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help blend water and oil-based ingredients, and may also function as a thickener or lubricant in the formulation.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1W6L629B4K
    Sulisobenzone is a chemical UV filter used in some topical products to help protect against sun damage. It works as a sunscreen ingredient that absorbs ultraviolet light before it reaches the skin.
  • 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.

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

The official label also stateswater, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

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

LabelerFamily Dollar Stores, Inc
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio21 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.

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 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 9 words ▾

Use for handwashing to decrease bacteria on the skin

⏱️ Dosage and Administration 11 words ▾

Directions wet hands apply palmful to hands scrub thoroughly rinse thoroughly

⚠️ Warnings 7 words ▾

Warnings For external use only: hands only

🤒 Adverse Reactions 47 words ▾

ADVERSE REACTION DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA MADE IN USA WITH US & FOREIGN COMPONENTS 100% SATISFACTION OR YOUR MONEY BACK! NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

🎯 Purpose 2 words ▾

Purpose Antibacterial

📄 When Using This Product 15 words ▾

When using this product avoid conctact with eyes. If contact occurs, rinse eyes with water.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours

📄 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 3 words ▾

Questions? Call 1-844-636-7687

📄 Package Label / Principal Display Panel 88 words ▾

principal display panel FAMILY Wellness™ COMPARE TO SOFTSOAP ® ANTIBACTERIAL HAND SOAP WHITE TEA & BERRY* BERRIES & WHITE TEA SCENT ANTIBACTERIAL HAND SOAP REFILL With moisturizers Helps kill harmful germs Dermatologist tested 50 FL OZ (1.56 QT)

1.47 L image description image description

principal display panel FAMILY Beauty™ COMPARE TO SOFTSOAP ® ANTIBACTERIAL HAND SOAP WHITE TEA & BERRY* BERRIES & WHITE TEA SCENT ANTIBACTERIAL HAND SOAP REFILL With moisturizers Helps kill harmful germs Dermatologist tested 50 FL OZ (1.56 QT)

1.47 L image description image description

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 — 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 Drug". 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 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 Family Dollar Stores, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Family Dollar Stores, Inc 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.
← 55319-0875-20 · Family 55319-0885-01 · Family →
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.