Home › NDC Lookup › Ingredients › Hydraphex › 78003-0140-80
HydrAphex .0013 g/mL Solution, 1045000 mL — NDC 78003-0140-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HydrAphex .0013 g/mL Solution, 1045000 mL — NDC 78003-140-80 (Billing 78003-0140-80)

by Aphex Biocleanse Systems, Inc · 1045000 mL in 1 CONTAINER

This is a package of 1,045,000 mL of HydrAphex .0013 g/mL Solution from Aphex Biocleanse Systems, Inc, marketed since Jun 2012 and currently FDA-listed, this package's marketing is listed to end Jan 2029.

NDC 78003-0140-80
🏷️ FDA NDC (as labeled) 78003-140-80 billing pads the product segment with a zero
This package
Contains1045000 mL Pack sizes2 compare ↓
Product page 78003-0140-70 Also comes in: 208000 ml 78003-140-70
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 78003-140-80 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
78003 labeler · 140 product · 80 package
Package marketed since
Jun 1, 2020
Package marketing ended
Jan 31, 2029
Sample package
No — commercial package
Barcode (UPC)
0850608003329
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 78003-140-80
Product NDC 78003-140
11-digit billing NDC 78003014080
UNII F5UM2KM3W7
UPC 0850608003329
Application # part333A
SPL Set ID a6035c7d-0f5b-3295-e053-2995a90af89c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-01
Marketing end 2029-01-31
Route TOPICAL
Dosage form SOLUTION
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 78003-140-80 — 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 → 78003-0140-80. 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?

HydrAphex is a topical solution containing benzalkonium chloride, a type of antimicrobial agent. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rule-book for its category rather than an individual product review. Benzalkonium chloride is typically used in topical products for its antimicrobial properties and commonly appears in antiseptic and disinfectant formulations meant for skin use.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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: 208000 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
78003-0140-70 78003-140-70 Main listing 208000 mL in 1 DRUM 2020-06-01 Jan 31, 2029 Active
78003-0140-80 You're viewing this 1045000 mL in 1 CONTAINER 2020-06-01 Jan 31, 2029 Active

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

Pack size FAQ

What quantity is in this package?
This package contains 1045000 mL — 1045000 ml in 1 container.
How does this package differ from NDC 78003-0140-70?
Both are HydrAphex .0013 g/mL Solution — the drug itself is identical. This page's package is the 1045000 mL one, while NDC 78003-0140-70 is the 208000 ml package.
What NDC number is used to bill for this package of HydrAphex .0013 g/mL Solution?
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
HydrAphex .0013 g/mLthis 78003-0140-80 Aphex 1045000 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

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 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.

  • 0.0006 g / 1 mL UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 1 mL / 1 mL 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.

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

The official label also statesInactive ingredients: -Water 99.83% -Carbamide to 0.04%

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

LabelerAphex Biocleanse Systems, Inc
FDA applicationpart333A (OTC MONOGRAPH NOT FINAL)
Labeler code78003
First marketedJun 2012
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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Usage Section Uses : For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

⏱️ Dosage and Administration 36 words ▾

Dosage and Admnstration Directions: Refill your container. 1 - 4 pumps into your palm. Rub foam until spread evenly over the entire surface of your hands. Continue rubbing until dry. Use frequently to avoid spreading germs.

⚠️ Warnings 62 words ▾

Warnings Warnings: For External Use Only Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice. Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns. If swallowed, get medical help or contact a poison control center right away. Keep Out of Reach of Children

🧪 Active Ingredient 13 words ▾

Active ingredient Active ingredients: Benzalkonium Chloride 0.11% - 0 .13% (As sanitizing agent)

🧪 Inactive Ingredients 9 words ▾

Inactive Ingredient Inactive ingredients: -Water 99.83% -Carbamide to 0.04%

🎯 Purpose 13 words ▾

Purpose Section Active ingredients: Benzalkonium Chloride 0.11% - 0 .13% (As sanitizing agent)

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of Children Keep Out of Reach of Children

📄 Package Label / Principal Display Panel 15 words ▾

HydrAphex Hanad Sanitizer 275 Gallon HydrAphex 275 Gallon

HydrAphex 55 Gallon Drum HydrAphex 55 Gallon

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 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 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 it is currently marketed — but Aphex Biocleanse Systems, Inc has reported a marketing end date of 2029-01-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 208000 ml (78003-0140-70). 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?
Aphex Biocleanse Systems, 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.
← 77964-0006-02 · HANSCOS 78041-0023-01 · Fusion →
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.