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Thera Wise Natural Hemorrhoidal Witch Hazel 3.36 g/28g Ointment — NDC 43347-158-01 (Billing 43347-0158-01)

by Derma Wise Skin Care Ltd. · 1 TUBE, WITH APPLICATOR in 1 BOX / 28 g in 1 TUBE, WITH APPLICATOR

This is a package of Thera Wise Natural Hemorrhoidal Witch Hazel 3.36 g/28g Ointment from Derma Wise Skin Care Ltd., marketed since Aug 2016 and currently FDA-listed. It is this product's only package size.

NDC 43347-0158-01
🏷️ FDA NDC (as labeled) 43347-158-01 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) 43347-158-01
Product NDC 43347-158
11-digit billing NDC 43347015801
RxCUI 1804849
UNII 101I4J0U34
Application # M016
SPL Set ID a29fb680-cfc8-4a7b-9970-563fa0e2bed6
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-15
Route RECTAL, TOPICAL
Dosage form OINTMENT
Substance WITCH HAZEL
Quick answers
  • RxCUI (RxNorm): 1804849
Why two NDCs? The FDA registers this code as 43347-158-01 — 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 → 43347-0158-01. 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.

Clinical

🧪 What is this product?

Thera Wise Natural Hemorrhoidal Witch Hazel is an over-the-counter ointment applied topically to the rectal area. Witch hazel is an astringent plant extract commonly used in hemorrhoidal products to help reduce inflammation and provide temporary relief of discomfort. This product is marketed under the FDA's OTC monograph rules for hemorrhoidal preparations rather than as an individually approved drug application.

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 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.
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
43347-0158-01 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 BOX / 28 g in 1 TUBE, WITH APPLICATOR 2016-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thera Wise Natural Hemorrhoidal 3.36 g/28gthis 43347-0158-01 Derma 1 tube — — 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

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 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

LabelerDerma Wise Skin Care Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code43347
First marketedAug 2016
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Uses For the temporary relief of anorectal discomfort associated with hemorrhoids For the temporary relief of local itching associated with hemorrhoids

⏱️ Dosage and Administration 108 words ▾

Directions When first opening, tear away safety seal. Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or pat and blot with appropriate cleansing pad. Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.

FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube. Lubricate applicator well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after each use and replace cover.

Apply to the affected area up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.

⚠️ Warnings 88 words ▾

Warnings For rectal and external use only Allergy alert: contains Asteracea (daisy) plant material Do not use this product with the applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly. Stop use and consult a doctor if: Condition worsens or does not improve within 7 days Bleeding occurs When using this product do not exceed the recommended daily dosage unless directed by your doctor.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 19 words ▾

Other information Store between 2° and 25° C (35° - 77° F) Do not use if seal is broken

🧪 Active Ingredient 5 words ▾

Active ingredient Witch Hazel 12%

🧪 Inactive Ingredients 64 words ▾

Inactive ingredients Aloe Vera Extract Certified Organic , Argan Kernel Oil, Butcher's Broom Extract, Cetearyl Olivate, Chamomile Flower Extract , Citric Acid, Dehydroacetic Acid, Glycerin, Grape Seed Oil, Hydrogenated Olive Oil, Oat Beta Glucan, Olive Oil, Olive Oil Unsaponifiables Olive Squalane, Seabuckthorn Fruit Oil, Sclerotium Gum, Shea Butter, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Sodium Steroyl Glutamate, Stearyl Alcohol, Sunflower Seed Oil, Tocopherols, Water

🎯 Purpose 4 words ▾

Purpose Astringent / Anti-inflammatory

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 Derma Wise Skin Care Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Derma Wise Skin Care Ltd. 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.
← 43337-9329-07 · Chang 43353-0009-30 · Aphena →
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.