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Witch Hazel 86 g/100mL Liquid, 473 mL — NDC 10565-040-16 (Billing 10565-0040-16)

by Hydrox Laboratories · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Witch Hazel 86 g/100mL Liquid from Hydrox Laboratories, marketed since Dec 2011 and currently FDA-listed. It is this product's only package size.

NDC 10565-0040-16
🏷️ FDA NDC (as labeled) 10565-040-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10565-040-16
Product NDC 10565-040
11-digit billing NDC 10565004016
RxCUI 200295
UNII 101I4J0U34
Application # 505G(a)(3)
SPL Set ID 73391eb3-c17c-4104-93b1-2decfb2ebdf9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-12-21
Route TOPICAL
Dosage form LIQUID
Substance WITCH HAZEL
Quick answers
  • RxCUI (RxNorm): 200295
Why two NDCs? The FDA registers this code as 10565-040-16 — 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 → 10565-0040-16. 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?

Witch Hazel is a liquid applied directly to the skin as an over-the-counter product. It is an astringent derived from the witch hazel plant and is typically used to help reduce skin irritation, minor inflammation, and excess oils on the skin. This product is marketed under the FDA's monograph system for astringent skin treatments.

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.
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
10565-0040-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2017-11-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Health Mart Witch Hazel 855 mg/mL 62011-0268-01 Strategic 473 ml $0.006 — FDA listed —
Sunmark Witch Hazel 855 mg/mL 49348-0181-38 Strategic 473 ml $0.007 — Availability likely —
GNP Witch Hazel 855 mg/mL 46122-0335-43 Amerisource 473 ml $0.008 — Availability likely —
Witch Hazel 842 mg/mL 70000-0615-01 Cardinal 473 ml $0.008 — Availability likely —
Witch Hazel 842 mg/mL 70677-1252-01 Strategic 473 ml $0.008 — Availability likely —
Witch Hazel 860 mg/mL 00363-0803-43 Walgreen 473 ml — — FDA listed —
Witch Hazel 86 g/100mLthis 10565-0040-16 Hydrox 473 ml — — FDA listed —
Witch Hazel 86 g/100mL 10733-0801-08 Medical 236 ml — — FDA listed —
Witch Hazel 860 mg/mL 11344-0822-43 Nice-Pak 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 21130-0822-43 Better 473 ml — — FDA listed —
Kroger Witch Hazel .86 g/mL 30142-0418-16 Kroger 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 30142-0822-43 The 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 37808-0822-43 H 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 41163-0822-43 United 473 ml — — FDA listed —
Witch Hazel 86 kg/100L 41250-0822-43 Meijer, 473 l — — FDA listed —
Witch Hazel 860 mg/mL 41520-0822-43 ADUSA 473 ml — — FDA listed —
Witch Hazel ReadyInCase 86 g/100mL 49580-0390-06 P 473 ml — — FDA listed —
TN Dickinsons Witch Hazel Astringent 86 g/100mL 52651-0001-04 Dickinson 3785 ml — — FDA listed —
Witch Hazel 860 mg/mL 55301-0822-43 Your 473 l — — FDA listed —
Witch Hazel 860 mg/mL 56062-0822-43 Publix 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 59779-0045-43 CVS 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 63941-0822-43 Valu 473 ml — — FDA listed —
Witch Hazel 86 g/100mL 70082-0008-16 DealMed 473 ml — — FDA listed —
Witch Hazel 86 g/100mL 71990-0001-01 Arcadia 473 ml — — FDA listed —
Witch Hazel 860 mg/mL 72288-0922-26 Amazon.com 118 ml — — Discontinued —
Witch Hazel 860 mg/mL 76162-0822-43 Topco 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

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 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

LabelerHydrox Laboratories
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code10565
First marketedDec 2011
Product typeHuman Otc Drug
Portfolio13 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.

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses For relief of minor skin irritations due to insect bites, minor cuts, minor scrapes.

⏱️ Dosage and Administration 19 words ▾

Directions Apply to the affected area as often as necessary. When using this product, avoid contact with the eyes.

⚠️ Warnings 24 words ▾

Warnings FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Witch Hazel 86%

🧪 Inactive Ingredients 6 words ▾

Inactive ingredient Alcohol 14% by volume

🎯 Purpose 2 words ▾

Purpose Astringent

📄 Stop Use and Ask a Doctor If 17 words ▾

Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days.

📄 Keep Out of Reach of Children 19 words ▾

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 39 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label Personal Care FreshMoment Witch Hazel Natural Astringent Cleans and Refreshes Skin No Artificial Fragrance or Dyes MADE IN USA 16 FL. OZ. (473mL) Principal Display Panel - 473 mL Bottle Label

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 — 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 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 Hydrox Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hydrox Laboratories 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.
← 10565-0007-04 · Hydrox 10565-0066-02 · Hydrox →
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.