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Proctofoam Ns pramoxine hydrochloride 150 mg/15g Aerosol, Foam — NDC 00037-6823-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Proctofoam Ns pramoxine hydrochloride 150 mg/15g Aerosol, Foam — NDC 0037-6823-15 (Billing 00037-6823-15)

by Viatris Specialty LLC · 1 CANISTER in 1 CARTON / 15 g in 1 CANISTER

This is a package of Proctofoam Ns pramoxine hydrochloride 150 mg/15g Aerosol, Foam from Viatris Specialty LLC, marketed since Aug 2014 and currently FDA-listed; retail pharmacies pay about $6.56 per g (NADAC). It is this product's only package size.

NDC 00037-6823-15
🏷️ FDA NDC (as labeled) 0037-6823-15 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

NDC database record

One package, one record: these facts belong to NDC 0037-6823-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0037 labeler · 6823 product · 15 package
Package marketed since
Aug 18, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0037682315 0
Medicaid fills, this package
58 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0037-6823-15
Product NDC 0037-6823
11-digit billing NDC 00037682315
NCPDP billing unit GM — per gram (weight)
RxCUI 828365, 828367
UNII 88AYB867L5
Application # M346
SPL Set ID cddc8d81-21b8-11e4-8c21-0800200c9a66
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-08-18
Route RECTAL
Dosage form AEROSOL, FOAM
Substance PRAMOXINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 89200030103905
GPI class Proctofoam
GCN Seq No 062043
GCN 97827
HICL code 002977
Ingredient (HICL) Pramoxine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q3
Therapeutic class — intermediate (HIC2) Anal-Rectal Preparations
HIC3 code Q3D
Therapeutic class — specific (HIC3) Hemorrhoidal Preparations
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name PROCTOFOAM 1% FOAM
FDB brand name Proctofoam
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 062043
  • GCN: 97827
  • GPI-14 (Medi-Span): 89200030103905
  • HICL (First Databank): 002977
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 828365
Why two NDCs? The FDA registers this code as 0037-6823-15 — 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 → 00037-6823-15. 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.

Clinical

Label name PROCTOFOAM 1% FOAM 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
  • It gives short-term relief from pain and itching from minor problems like sunburn, minor burns, insect bites, and poison ivy rashes. Some products are made for specific uses, like...
  • That depends on the product. Many say not more than 3 to 4 times daily, and some allow up to 5 times daily. Check your label and follow it closely.
  • No. It is for external use only. If it gets in your eyes, rinse thoroughly with water.
  • Can I use it inside the vagina or near my eyes?
📖 Read our full Pramoxine guide →
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 $6.562 $98.42 / 15 g
Medicaid paysCMS SDUD · 12 mo $6.54 $98.16 / 15 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Jan 2026 May 2026 Jun 2026 Sep 2026 $7.173 $6.562
▼ Down 1% over the last 5 months.
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
00037-6823-15 You're viewing this Main listing 1 CANISTER in 1 CARTON / 15 g in 1 CANISTER 2014-08-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proctofoam Ns 150 mg/15gthis 00037-6823-15 Viatris 1 canister $6.561 — Availability likely —
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

🏛️
2014
On the market since
Aug 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Pramoxine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
  • UNII N72LMW566G
    A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • UNII T75W9911L6
    A flammable gas used as a propellant in aerosol formulations. It helps dispense the medicine as a fine mist or spray when you activate the inhaler or pump.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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.

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

The official label also statescetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine

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

LabelerViatris Specialty LLC
FDA applicationM346 (OTC MONOGRAPH DRUG)
Labeler code00037
First marketedAug 2014
Product typeHuman Otc Drug
Portfolio122 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 12 words ▾

Use for the temporary relief of pain and itching associated with hemorrhoids

⏱️ Dosage and Administration 71 words ▾

Directions • place cap on container. Shake well before use • adults: when practical, cleanse the 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 • dispense onto a clean tissue and apply externally to the affected area up to 5 times daily • children under 12 years of age: consult a physician

⚠️ Warnings 131 words ▾

Warnings For external use only When using this product • 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 • do not insert any part of the aerosol container into the rectum Stop use and ask a doctor if • rectal bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction occurs to the ingredients in this product • symptom being treated does not subside • redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use.

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 Pramoxine hydrochloride 1%

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine

🎯 Purpose 3 words ▾

Purpose Local anesthetic

📄 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.

📄 Other Information 53 words ▾

Other information • store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) • do not refrigerate • contents of the container are under pressure. Do not burn or puncture the aerosol container • do not store at temperatures above 49°C (120°F)

📄 Questions or Comments 27 words ▾

Questions? 1-888-350-1908 Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. © 2025 Viatris Inc. PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company..

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal Display Panel – 1% NDC 0037-6823-15 TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals ® seal on ends of carton are broken or missing. proctofoam ® non-steroid pramoxine hydrochloride 1% hemorrhoidal foam For temporary relief of hemorrhoidal pain and itching STORE UPRIGHT NET WT.

0.53OZ (15 g) Drug Facts Active ingredient Purpose Pramoxine hydrochloride 1%. . . . . . . . Local anesthetic Use for the temporary relief of pain and itching associated with hemorrhoids Warnings For external use only When using this product • 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 • do not insert any part of the aerosol container into the rectum Stop use and ask a doctor if • rectal bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction occurs to the ingredients in this product • symptom being treated does not subside • redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions • place cap on container.

Shake well before use • adults: when practical, cleanse the 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 • dispense onto a clean tissue and apply externally to the affected area up to 5 times daily • children under 12 years of age: consult a physician Drug Facts (continued) Other information • store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) • do not refrigerate • contents of the container are under pressure.

Do not burn or puncture the aerosol container • do not store at temperatures above 49°C (120°F) Drug Facts (continued) Inactive ingredients cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine Questions? 1-888-350-1908 Distributed by: MEDA PHARMACEUTICALS ® Canonsburg, PA 15317 U.S.A. ©2025 Viatris Inc. PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company.

117789 UC-82315-15-05 Proctofoam Hydrochloride Foam Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
58
Units reimbursed last 4 qtrs
975
Gross reimbursed last 4 qtrs
$6.4K
Avg / prescription
$110.01
Avg / unit
$6.5443
Latest quarter Q1 2026
16Rx
Medicaid pays / g
$6.5443
gross reimbursed
vs
NADAC / g
$6.5615
acquisition cost
=
Spread
−$0.0172
+0% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 58 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 795 units · 6.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 180 units · 9.1 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.19.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 9.1 /100k
2 Pennsylvania 6.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 PROCTOFOAM NS (this brand).

Top reported reactions

Dyspnoea29
Cough25
Gastrooesophageal Reflux Disease24
Oedema Peripheral23
Chronic Kidney Disease22
Diarrhoea22
Weight Increased21

Age at onset

Child3
Adolescent1
Adult18
Elderly12

Reporter sex

280 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization110
Death28
Disabling5
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 21 0
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.
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.