BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Cupcake BENZALKONIUM CHLORIDE .12 mg/mL Liquid, 250 mL
by KAS Direct LLC dba BabyGanics · 250 mL in 1 BOTTLE, PUMP (59062-4201-1)
NDC 59062-4201-01
🏷️ FDA NDC (as labeled)
59062-4201-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 ↗
🆔 Identity & classification
FDA NDC (as labeled)
59062-4201-1
Product NDC
59062-4201
11-digit billing NDC
59062420101
UNII
F5UM2KM3W7
UPC
0813277019206, 0813277019213
Application #
505G(a)(3)
SPL Set ID
75ae3b5e-b583-4b80-b4ab-5cc40978ca30
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-06-06
Marketing end
2027-12-31
Route
TOPICAL
Dosage form
LIQUID
Substance
BENZALKONIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 59062-4201-1 — a 5-4-1 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 package segment → 59062-4201-01. 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
LabelerKAS Direct LLC dba BabyGanics
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code59062
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio17 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.
🩺 Clinical
🧪 What is this product?
This is an over-the-counter foaming hand sanitizer liquid applied topically to the skin. It contains benzalkonium chloride, an antimicrobial ingredient typically used in hand sanitizers to help reduce bacteria and certain other microorganisms on the hands. The product is marketed under FDA's standard rules for over-the-counter antimicrobial hand sanitizers and is formulated without alcohol.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzalkonium Chloride — tap one for details:
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.
💬 Questions about BENZALKONIUM CHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
-
UNII B423VGH5S9
A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
-
UNII P0M7O4Y7YD
A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
-
UNII UC9PE95IBP
A synthetic compound that works as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the shelf life of liquid formulations like eye drops and topical solutions.
-
UNII FGL3685T2X
Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
-
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 M4SL82J7HK
A foaming and cleansing agent derived from coconut oil. It's used in liquid formulations to create texture, improve spreadability, and help distribute active ingredients evenly throughout the product.
-
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 6UYK2W1W1E
A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
-
UNII 5965N8W85T
Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
-
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.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateswater, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic. Learn more about these and all our ingredients and the choices we make at babyganics.com/products, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, olea europaea (olive) leaf extract, glycerin, citric acid, fragrance Product formulated using ingredients chosen with kids in mind, including plant-derived fragrance.
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.
💲 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 system | Per mL | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry Berry .12 mg/mL 59062-4101-01 | KAS | 250 ml | — | — | FDA listed | — |
| BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Cupcake .12 mg/mLthis 59062-4201-01 | KAS | 250 ml | — | — | FDA listed | — |
| BabyGanics Alcohol-Free Foaming Hand Sanitizer Mandarin .12 mg/mL 59062-4001-01 | KAS | 473 ml | — | — | FDA listed | — |
| BabyGanics Alcohol-Free Foaming Hand Sanitizer .12 mg/mL 59062-3001-01 | KAS | 473 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
🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Cupcake (this brand).
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59062-4201-01 You're viewing this | 250 mL in 1 BOTTLE, PUMP (59062-4201-1) | 2022-06-06 | Active |
🧭 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 FDA registers it as 59062-4201-1, 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: 59062-4201-01, written without dashes as 59062420101. 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 59062-4201-01, the first segment (59062) is the labeler code FDA assigned to KAS Direct LLC dba BabyGanics; the middle segment (4201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but KAS Direct LLC dba BabyGanics has reported a marketing end date of 2027-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
KAS Direct LLC dba BabyGanics 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 ▾
Uses for hand sanitizing to decrease bacteria on the skin recommended for repeated use
⏱️ Dosage and Administration ▾
Directions pump a small amount of foam into palm of hand rub thoroughly over all surfaces of both hands rub hands together briskly until dry
⚠️ Warnings ▾
Warnings For external use only When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or redness develops, or if condition lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredient Benzalkonium chloride 0.12%
🧪 Inactive Ingredients ▾
Inactive ingredients water, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic. Learn more about these and all our ingredients and the choices we make at babyganics.com/products , calendula officinalis flower extract , chamomilla recutita (matricaria) flower extract , olea europaea (olive) leaf extract , glycerin, citric acid, fragrance Product formulated using ingredients chosen with kids in mind, including plant-derived fragrance.
🎯 Purpose ▾
Purpose Antimicrobial
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.