Home › NDC Lookup › Ingredients › Benzalkonium Chloride › 77238-0241-41
Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Spray, 30 mL — NDC 77238-0241-41 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Spray, 30 mL — NDC 77238-241-41 (Billing 77238-0241-41)

by DGH Pharma, Inc. · 30 mL in 1 BOTTLE

This is a package of 30 mL of Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Spray from DGH Pharma, Inc., marketed since Sep 2020 and currently FDA-listed.

NDC 77238-0241-41
🏷️ FDA NDC (as labeled) 77238-241-41 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes3 compare ↓
Product page 77238-0241-11 Also comes in: 30 ml 77238-241-11 30 ml 77238-241-21
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 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 77238-241-41 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
77238 labeler · 241 product · 41 package
Package marketed since
Jul 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0860003616352
FDA record last changed
Aug 6, 2026
⚠️
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) 77238-241-41
Product NDC 77238-241
11-digit billing NDC 77238024141
RxCUI 1052947
UNII F5UM2KM3W7
UPC 0860003616352
Application # M003
SPL Set ID afeccd10-c7e5-6193-e053-2995a90a9a5a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-01
Route TOPICAL
Dosage form SPRAY
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1052947
Why two NDCs? The FDA registers this code as 77238-241-41 — 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 → 77238-0241-41. 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical spray hand sanitizer containing benzalkonium chloride as its active ingredient. Benzalkonium chloride is an antimicrobial agent typically used in antiseptic and disinfectant products to reduce bacteria and other microorganisms on the skin. This product is formulated and marketed under FDA's over-the-counter monograph rules for hand sanitizers rather than as an individually approved drug application.

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: 30 ml 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
77238-0241-11 77238-241-11 Main listing 30 mL in 1 BOTTLE 2020-09-01 — Active
77238-0241-21 77238-241-21 30 mL in 1 BOTTLE 2020-10-05 — Active
77238-0241-41 You're viewing this 30 mL in 1 BOTTLE 2022-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 30 mL — 30 ml in 1 bottle.
How does this package differ from NDC 77238-0241-11?
Both are Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Spray — the drug itself is identical. This page's package is the 30 mL one, while NDC 77238-0241-11 is the 30 ml package.
What NDC number is used to bill for this package of Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Spray?
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
My-Shield Sanitizing Body .1 g/100mL 71884-0009-02 Enviro 58 ml — — Discontinued —
germfree24 Sanitizing Body-Spray .1 g/100mL 71884-0017-01 Enviro 10 ml — — Discontinued —
Triple Shield .1 g/100mL 71884-0034-16 Enviro 473 ml — — Discontinued —
Hand Sanitizer .1 g/100mLthis 77238-0241-41 DGH 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerDGH Pharma, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code77238
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from DGH Pharma, Inc. labeler code 77238

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Use Spray on mask and hands to sanitize & protect against bacteria and pathogens.

⏱️ Dosage and Administration 11 words ▾

Directions Spray on hands and on each side of your mask

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 8 words ▾

Active Ingredient(s) Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients D-Limonene, Copper Chloide, Glycerin, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, Purified Water, Trisodium Citrate

🎯 Purpose 4 words ▾

Purpose Antiseptic, Hand Sanitizer

📄 When Using This Product 45 words ▾

When using this product keep out of eyes. In case of contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

📄 Stop Use and Ask a Doctor If 11 words ▾

Stop use and ask a doctor if irritation or redness develops.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 13 words ▾

Package Label - Principal Display Panel product image

Additional Label 30 mL Spray

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 DGH Pharma, Inc.. 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 30 ml (77238-0241-11), 30 ml (77238-0241-21). 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?
DGH Pharma, 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.
← 77238-0231-11 · DGH 77333-0031-20 · Gendose →
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.