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Lidocaine Hemorrhoid Lidocaine HCl, Phenylephrine HCl, Witch Hazel 50 g/100g; .25 g/100g; 5 g/100g Spray, 85 g — NDC 00363-1657-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lidocaine Hemorrhoid Lidocaine HCl, Phenylephrine HCl, Witch Hazel 50 g/100g; .25 g/100g; 5 g/100g Spray, 85 g — NDC 0363-1657-03 (Billing 00363-1657-03)

by Walgreens Co · 85 g in 1 CAN

This is a package of 85 g of Lidocaine Hemorrhoid Lidocaine HCl, Phenylephrine HCl, Witch Hazel 50 g/100g; .25 g/100g; 5 g/100g Spray from Walgreens Co, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 00363-1657-03
🏷️ FDA NDC (as labeled) 0363-1657-03 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 0363-1657-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0363 labeler · 1657 product · 03 package
Package marketed since
Feb 5, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0311917040509
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-1657-03
Product NDC 0363-1657
11-digit billing NDC 00363165703
RxCUI 2099775
UNII 101I4J0U34, 04JA59TNSJ, EC2CNF7XFP
UPC 0311917040509
Application # M015
SPL Set ID 10a47899-f4a0-66e8-e063-6394a90a11dd
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-05
Route TOPICAL
Dosage form SPRAY
Substance WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Quick answers
  • RxCUI (RxNorm): 2099775
Why two NDCs? The FDA registers this code as 0363-1657-03 — a 4-4-2 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 labeler segment → 00363-1657-03. 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.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is an over-the-counter topical spray marketed under FDA's OTC monograph rules for hemorrhoid products. It contains lidocaine, a local anesthetic typically used to numb pain and itching, along with phenylephrine, a decongestant that functions to reduce swelling and blood flow to the area. Witch hazel is an astringent extract commonly included in hemorrhoid formulations. The spray is applied directly to the affected area to provide temporary relief of hemorrhoid symptoms.

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
00363-1657-03 You're viewing this Main listing 85 g in 1 CAN 2024-02-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Hemorrhoid 50 g/100g; .25 g/100g; 5 g/100gthis 00363-1657-03 Walgreens 85 g — — FDA listed —
Dr Butlers Advanced Hemorrhoid Relief 50 g/100g; 5 g/100g; .25 g/100g 70942-0127-05 Beyond 142 g — — FDA listed —
myDerm MEDICAL NEW Soothing Hemorrhoidal 50 g/100g; .25 g/100g; 5 g/100g 72667-0287-05 Inspec 127 g — — 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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII O2T154T6OG
    A natural plant extract from chamomile flowers. It's used as a flavoring and fragrance ingredient in medicines to improve taste or aroma.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 7NV86426N2
    A plant extract from narrow-leaved willowherb leaves. It's used in formulations as a natural ingredient to support texture, consistency, or sensory appeal of the product.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII STI11B5A2X
    Polysorbate 40 is a synthetic emulsifier derived from sorbitol and fatty acids. It helps keep oils and water mixed together in liquid medications and also improves how the product flows.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 1W6L629B4K
    Sulisobenzone is a chemical UV filter used in some topical products to help protect against sun damage. It works as a sunscreen ingredient that absorbs ultraviolet light before it reaches the skin.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • 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.

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

The official label also statesalcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.

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

LabelerWalgreens Co
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Walgreens Co labeler code 00363

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

Temporarily shrinks hemorrhoidal tissue Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders aids in protecting irritated anorectal areas

Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders. Aids in protecting irritated anorectal areas.

⏱️ Dosage and Administration 66 words ▾

Adults: when practical, cleanse the affected are with an appropriate cleansing wipe. Spray rectal area until thoroughly moist. Wipe off excess with tissue. Gently dry by patting or blotting with a tissue or a soft cloth. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age, consult a doctor.

⚠️ Warnings 182 words ▾

For external use only. Flammable. Do not use while smoking or near heat or flame.

When using this product keep away from children avoid spraying in eyes contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator certain persons can develop allergic reactions to ingredients in this product.

If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. Ask a doctor or pharmacist before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland are presently taking a prescription drug for high blood pressure or depression Stop use and ask a doctor if bleeding occurs condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days needed for longer than 1 week

🧪 Active Ingredient 9 words ▾

Lidocaine HCl 5%, Phenylephrine HCl 0.25%, Witch Hazel 50%

🧪 Inactive Ingredients 32 words ▾

alcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.

🎯 Purpose 4 words ▾

Anorectal; anesthetic, vasoconstrictor, astringent

🤰 If Pregnant or Breast-Feeding 6 words ▾

Ask a health professional before use.

📄 Keep Out of Reach of Children 13 words ▾

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

📄 Questions or Comments 1 words ▾

1-800-925-4733

📄 Package Label / Principal Display Panel 1 words ▾

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 ✓ 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 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 Walgreens Co. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreens Co 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.
← 00363-1652-28 · WALGREENS 00363-1686-07 · WALGREENS →
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.