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Omnicide Antimicrobial BENZALKONIUM CHLORIDE 0.13 g/100g Gel, 45 g

by SteriWeb Medical, LLC · 45 g in 1 TUBE (69085-466-02)
NDC 69085-0466-02
🏷️ FDA NDC (as labeled) 69085-466-02 billing pads the product segment with a zero
This package
Contains45 g Pack sizes2 compare ↓
Also comes in: 30 g 69085-0466-05
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 15, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2017. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 69085-466-02
Product NDC 69085-466
11-digit billing NDC 69085046602
Application # part333A
SPL Set ID 20b6fc0a-317b-4b94-b598-c53ebea114fe
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2017)
Route TOPICAL
Dosage form GEL
Substance BENZALKONIUM CHLORIDE
GCN Seq No 067723
GCN 30339
HICL code 004258
Ingredient (HICL) Benzalkonium Chloride
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8E
Therapeutic class — specific (HIC3) Antiseptics,General
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name OMNICIDE 0.13% GEL
FDB brand name Omnicide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 69085-466-02 — 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 → 69085-0466-02. 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.

🏭 Manufacturer & labeler

LabelerSteriWeb Medical, LLC
FDA applicationpart333A (OTC MONOGRAPH NOT FINAL)
Labeler code69085
Product typeHuman Otc Drug
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

Label name OMNICIDE 0.13% GEL Ingredient Benzalkonium Chloride
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.

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.

💲 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 g
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
Mentholatum Moisturizing Hand Sanitizer 1.3 mg/mL 10742-0004-01 The 192 ml — — FDA listed —
XtraCare Foaming Hand Sanitizer 3 g/207g 57337-0057-01 Rejoice 207 g — — FDA listed —
Germ Free Topical Antiseptic 1.3 mg/mL 71884-0008-02 Enviro 57 ml — — FDA listed —
My-Shield Hand Sanitizer Gel .13 g/100mL 71884-0011-01 Enviro 3 tubes — — Discontinued —
My-Shield Topical Antiseptic 1.3 mg/mL 71884-0025-01 Enviro 30 ml — — FDA listed —
Doctor Inks Topical Antiseptic 1.3 mg/mL 71884-0203-01 Enviro 30 ml — — FDA listed —
NasalGuard Antiseptic Topical Cool Menthol 1.3 mg/1000mg 81907-0101-03 TRUTEK 1 tube — — FDA listed —
Unscented NasalGuard Antiseptic Topical 1.3 mg/1000mg 81907-0102-03 TRUTEK 1 tube — — FDA listed —
Omnicide Antimicrobial 0.13 g/100gthis 69085-0466-02 SteriWeb 45 g — — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69085-0466-02 You're viewing this 45 g in 1 TUBE (69085-466-02) 2014-07-02 Inactivated by FDA
69085-0466-05 30 g in 1 TUBE (69085-466-05) 2016-05-07 Inactivated by FDA

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 69085-0466-02?
NDC 69085-0466-02 contains 45 g — 45 g in 1 tube.
What is the difference between NDC 69085-0466-02 and NDC 69085-0466-05?
Both are Omnicide Antimicrobial BENZALKONIUM CHLORIDE 0.13 g/100g Gel — the drug itself is identical. NDC 69085-0466-02 is the 45 g package, while NDC 69085-0466-05 is the 30 g package.
What NDC number is used to bill for this package of Omnicide Antimicrobial BENZALKONIUM CHLORIDE 0.13 g/100g Gel?
Bill NDC 69085-0466-02 — the 11-digit billing format is 69085046602. 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 No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 69085-466-02, 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: 69085-0466-02, written without dashes as 69085046602. 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 69085-0466-02, the first segment (69085) is the labeler code FDA assigned to SteriWeb Medical, LLC; the middle segment (0466) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 g (69085-0466-05). 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?
SteriWeb Medical, 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 17 words ▾

Uses First aid to help treat, protect and prevent skin infection associated with minor cuts scrapes burns

⏱️ Dosage and Administration 39 words ▾

Directions adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) children under 2 years: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 6 words ▾

Active Ingredient Benzalkonium Chloride 0.13% w/w

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredients USP Petrolatum, Water, Polihexanide (PHBM)

🎯 Purpose 4 words ▾

Purpose First Aid Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69079-0182-10 · Titan 69087-0158-12 · TOLMAR →
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.