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Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Gel, 30 mL — NDC 77238-0231-11 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 Gel, 30 mL — NDC 77238-231-11 (Billing 77238-0231-11)

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

This is a package of 30 mL of Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Gel from DGH Pharma, Inc., marketed since Sep 2020 and currently FDA-listed. It is the main listing for this product, which comes in 7 package sizes.

NDC 77238-0231-11
🏷️ FDA NDC (as labeled) 77238-231-11 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes7 compare ↓
Main listing for product 77238-231 · Also comes in: 30 ml 77238-231-31 30 ml 77238-231-41 118 ml 77238-231-14 118 ml 77238-231-24 118 ml 77238-231-44 3785 ml 77238-231-48
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 77238-231-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
77238 labeler · 231 product · 11 package
Package marketed since
Sep 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0086000361631
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) 77238-231-11
Product NDC 77238-231
11-digit billing NDC 77238023111
RxCUI 1049228
UNII F5UM2KM3W7
UPC 0086000361631
Application # M003
SPL Set ID ae4311f8-fc40-38a7-e053-2a95a90ae829
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 GEL
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1049228
Why two NDCs? The FDA registers this code as 77238-231-11 — 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 → 77238-0231-11. 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 a topical hand sanitizer gel containing benzalkonium chloride, an antimicrobial agent typically used to reduce bacteria and some other microorganisms on the skin. The product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for hand sanitizers rather than undergoing individual product review. Benzalkonium chloride functions as a broad-spectrum antimicrobial commonly found in antiseptic and disinfectant products applied directly to the hands or skin.

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.
Try another pack size: 30 ml 30 ml 118 ml 118 ml 118 ml 3785 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
77238-0231-11 You're viewing this Main listing 30 mL in 1 BOTTLE, SPRAY 2020-09-01 — Active
77238-0231-14 77238-231-14 118 mL in 1 BOTTLE 2020-09-01 — Active
77238-0231-24 77238-231-24 118 mL in 1 BOTTLE 2020-10-06 — Active
77238-0231-31 77238-231-31 30 mL in 1 BOTTLE, SPRAY 2022-06-01 — Active
77238-0231-41 77238-231-41 30 mL in 1 BOTTLE, SPRAY 2022-07-01 — Active
77238-0231-44 77238-231-44 118 mL in 1 BOTTLE 2022-07-01 — Active
77238-0231-48 77238-231-48 3785 mL in 1 JUG 2022-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 30 mL — 30 ml in 1 bottle, spray.
How does this package differ from NDC 77238-0231-31?
Both are Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Gel — the drug itself is identical. This page's package is the 30 mL one, while NDC 77238-0231-31 is the 30 ml package.
What NDC number is used to bill for this package of Hand Sanitizer BENZALKONIUM CHLORIDE .1 g/100mL Gel?
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
fomin mini Hand Sanitizer Wipes MELON POP .1 g/100mL 85755-0002-08 Fomin 6 packets — — FDA listed —
Ops Instant Hand Sanitizer .1 g/100mL 79016-0105-12 Archer 1000 ml — — FDA listed —
fomin mini Hand Sanitizer Wipes COCO-NILLA BLISS .1 g/100mL 85755-0001-08 Fomin 6 packets — — FDA listed —
Nuvik Large Roll in Bucket Antibacterial Hand Wipes .1 g/100mL 74602-0900-80 Nuvik 1 pail — — FDA listed —
fomin mini Hand Sanitizer Wipes FRAGRANCE FREE .1 g/100mL 85755-0003-08 Fomin 6 packets — — FDA listed —
Hustle Butter Antibacterial Foaming .1 g/100mL 72014-0200-07 H.B.D. 207 ml — — Discontinued —
Non -Alcohol Cherry Scented Hand Sanitizer .1 g/100mL 54860-0612-01 Shenzhen 59 ml — — FDA listed —
Hand Sanitizer .1 g/100mLthis 77238-0231-11 DGH 30 ml — — FDA listed —
Non -Alcohol Grape Scented Hand Sanitizer .1 g/100mL 54860-0611-01 Shenzhen 59 ml — — FDA listed —
Non -Alcohol Peach Scented Hand Sanitizer .1 g/100mL 54860-0610-01 Shenzhen 59 ml — — FDA listed —
Non -Alcohol Blueberry scented Hand sanitizer .1 g/100mL 54860-0613-01 Shenzhen 59 ml — — FDA listed —
Claravie .1 g/100mL 61554-0315-41 Gentell 237 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.

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

  • 0.201 g / 100 mL UNII S2QG84156O
    Cupric chloride is a copper-based chemical salt. It may be used as a colorant or to provide trace copper in fortified formulations, helping achieve the desired appearance or nutritional content of the medicine.
  • 1.65 g / 100 mL 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.
  • 0.65 g / 100 mL UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • 0.18 g / 100 mL UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • 0.05 g / 100 mL UNII NBZ3QY004S
    Magnesium hydroxide is a mineral compound that acts as a buffer and pH adjuster in medications. It helps neutralize stomach acid and keeps the medicine at the right acidity level for stability and absorption.
  • 0.4 g / 100 mL UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 1.65 g / 100 mL UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 1.95 g / 100 mL UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • 2 g / 100 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 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 statesCitrus Sinensis (Orange) Fruit Oil, Copper Chloride, Glycerin, Hydroxyethylcellulose, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, 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

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 9 words ▾

Use To eliminate viruses and bacteria on the skin

⏱️ Dosage and Administration 15 words ▾

Directions Rub thoroughly over all surfaces of both hands. Rub hands toghether briskly unitl dry.

⚠️ 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 20 words ▾

Inactive ingredients Citrus Sinensis (Orange) Fruit Oil, Copper Chloride, Glycerin, Hydroxyethylcellulose, Magnesium Hydroxide, PEG-8, PEG-90, Phenoxyethanol, Polysorbate 20, Purified Water

🎯 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 17 words ▾

Package Label - Principal Display Panel product image

Package Label for second product 118 mL Impact Glove

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 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 6 other package presentations of this same product, including 30 ml (77238-0231-31), 30 ml (77238-0231-41), 118 ml (77238-0231-14). 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.
← 77133-0003-00 · ALCOVE 77238-0241-11 · DGH →
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.