Home › NDC Lookup › Ingredients › Pramoxine Hydrochloride › 58980-0522-40
Pramoxine Hydrochloride Anorectal 1 mg/mL Lotion — NDC 58980-0522-40 package photo

Pramoxine Hydrochloride Anorectal 1 mg/mL Lotion

by Stratus Pharmaceuticals · 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE
NDC 58980-0522-40
🏷️ FDA NDC (as labeled) 58980-522-40 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 237 mL 58980-0522-80
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 58980-522-40
Product NDC 58980-522
11-digit billing NDC 58980052240
NCPDP billing unit ML — per mL (volume)
RxCUI 1246075
UNII 88AYB867L5
Application # M015
SPL Set ID 39a16b66-b0e9-412f-8773-8dec0a1227e0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-01
Route TOPICAL
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE
GCN Seq No 007423
GCN 30520
HICL code 002977
Ingredient (HICL) Pramoxine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name PRAMOXINE HCL 1 % LOTION
FDB brand name Pramoxine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 58980-522-40 — 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 → 58980-0522-40. 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 Local anesthetics class.

Drug family (ATC) 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.

🏭 Manufacturer & labeler

LabelerStratus Pharmaceuticals
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code58980
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio4 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

Label name PRAMOXINE HCL 1 % LOTION Ingredient Pramoxine Hcl
📖 What it is MedlinePlus · NLM

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Pramoxine is a local anesthetic, which means it temporarily numbs the area where you apply it. It works right at the skin's surface to block the sensation of pain and itching. It d...
  • What exactly does pramoxine do — how does it stop the itching?
  • It depends on which product you have. Most creams, sprays, and solutions are used up to 3 to 4 times daily. Some products, like Proctofoam for the rectal area, can be used up to 5...
  • No. All pramoxine products are for external use only — that means the outside of the skin. Even products intended for the genital or rectal area, like the Terramed Intimate Wash or...
📖 Read our full Pramoxine guide →

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.

🧪 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • 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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII ECU18C66Q7
    PEG-40 stearate is a synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients together and improve how the medicine dissolves and is absorbed.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statesCarbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum.

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 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.
Try another pack size: 237 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sarna 10 mg/mL 00316-0230-75 Crown 222 ml — — Discontinued —
Walgreen Anti-Itch 1 g/100g 00363-0263-75 Walgreens 212 g — — FDA listed —
DerMend Moisturizing Anti-Itch 10 mg/mL 00496-0586-08 Ferndale 237 ml — — FDA listed —
Prax 10 mg/mL 00496-0748-03 Ferndale 237 ml — — FDA listed —
CeraVe Developed with Dermatologists Itch Relief Moisturizing 1 mg/mL 49967-0970-01 L'Oreal 237 ml — — FDA listed —
Prax 10 mg/mL 50268-0682-15 AvPAK 237 ml — — FDA listed —
CVS Itch relief moisturizing 1 g/100mL 51316-0144-01 CVS 237 ml — — FDA listed —
Pramoxine Hydrochloride Anorectal 1 mg/mLthis 58980-0522-40 Stratus 1 bottle — — FDA listed —
Peviderm Pramoxine Hydrocholride 1% 1 mg/mL 58980-0913-80 Stratus 1 bottle — — FDA listed —
CVS Anti-Itch 1 g/100g 69842-0263-75 CVS 212 g — — FDA listed —
Prosoria Anti-Itch Moisturizer .9 g/90mL 71573-0120-11 Nuvothera, 90 ml — — FDA listed —
Prequel Anti-Itch Solution Medicated Calming 1 g/100g 82800-0200-01 The 400 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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 Pramoxine Hydrochloride Anorectal (this brand).

Top reported reactions

Chest Discomfort14
Dyspnoea14
Sinusitis14
Candida Infection13
Cough13
Deep Vein Thrombosis13
Dyspnoea Exertional13

Age at onset

Child1
Adult8
Elderly5

Reporter sex

69 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization18
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 8 4
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 NDCDescription Marketing startStatus
58980-0522-40 You're viewing this 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE 2025-11-01 Active
58980-0522-80 1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE 2025-11-01 Active

Pack size FAQ

What quantity is in NDC 58980-0522-40?
NDC 58980-0522-40 is listed by the FDA — 1 bottle in 1 box / 118 ml in 1 bottle.
What NDC number is used to bill for this package of Pramoxine Hydrochloride Anorectal 1 mg/mL Lotion?
Bill NDC 58980-0522-40 — the 11-digit billing format is 58980052240. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 58980-522-40, 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: 58980-0522-40, written without dashes as 58980052240. 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 58980-0522-40, the first segment (58980) is the labeler code FDA assigned to Stratus Pharmaceuticals; the middle segment (0522) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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: this package is listed as actively marketed, with no marketing end date reported by Stratus Pharmaceuticals. Listing status can change — 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 1 bottle (58980-0522-80). 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?
Stratus Pharmaceuticals 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 13 words ▾

Use for the temporary relief of itching and discomfort in the perianal area.

⏱️ Dosage and Administration 64 words ▾

Directions Shake well before using. When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Adults and children 12 years of age and older: apply to affected area up to five times daily. Children under 12 years of age, consult a Physician.

⚠️ Warnings 96 words ▾

Warnings for external use only. Do not exceed the recommended daily dosage unless directed by a Physician. Do not put this product into rectum by using fingers or any applicator.

Stop use and ask a Physician if Condition worsens Symptoms do not improve in 7 days Allergic reactions develop to ingredients in this product Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active ingredient Pramoxine HCL 1% w/w

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Carbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum.

🎯 Purpose 3 words ▾

Purpose Local Anesthetic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58980-0415-04 · Stratus 58980-0615-40 · STRATUS →
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.