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PREPARATION H Maximum Strength glycerin, petrolatum, phenylephrine HCl, pramoxine HCl 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g Cream — NDC 00573-2868-10 package photo

PREPARATION H Maximum Strength glycerin, petrolatum, phenylephrine HCl, pramoxine HCl 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g Cream

by Haleon US Holdings LLC · 1 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBE
NDC 00573-2868-10
🏷️ FDA NDC (as labeled) 0573-2868-10 billing pads the labeler segment with a zero
This package
Contains26 g in 1 tube Pack sizes4 compare ↓
Also comes in: 51 g 00573-2868-20 26 g 00573-2868-93 51 g 00573-2868-98
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0573-2868-10
Product NDC 0573-2868
11-digit billing NDC 00573286810
NCPDP billing unit GM — per gram (weight)
RxCUI 1293649
UNII PDC6A3C0OX, 04JA59TNSJ, 88AYB867L5, 4T6H12BN9U
Application # M015
SPL Set ID 7cc03d2e-e708-589a-d9bb-58ebbda989c0
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-07-01
Route TOPICAL
Dosage form CREAM
Substance GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
GPI-14 89992004743720
GPI class Preparation H
GCN Seq No 061414
GCN 97205
HICL code 034011
Ingredient (HICL) Phenyleph/Pramoxin/Glycr/W.pet
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 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name PREPARATION H CREAM
FDB brand name Preparation H
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0573-2868-10 — 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 → 00573-2868-10. 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

LabelerHaleon US Holdings LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00573
First marketedJul 2004
Product typeHuman Otc Drug
Portfolio404 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 PREPARATION H CREAM Ingredient Phenyleph/Pramoxin/Glycr/W.pet
🧪 What is this product?

Preparation H Maximum Strength is a topical cream marketed under FDA's over-the-counter monograph rules for hemorrhoidal products. It contains phenylephrine hydrochloride, a decongestant that narrows blood vessels and is typically used to reduce swelling and itching in the rectal area. Pramoxine hydrochloride functions as a topical numbing agent commonly used to relieve pain and discomfort. Glycerin and petrolatum serve as moisturizing and protective ingredients that help soothe and soften the skin.

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.

💊 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.

💡 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 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 1O6C93RI7Z
    Dexpanthenol is a naturally derived compound related to B vitamins. It acts as a humectant and skin conditioning agent, helping the medicine absorb moisture and maintain softness in topical formulations.
  • 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 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 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredients aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

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: 51 g 26 g 51 g
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
Good Sense Hemorrhoidal Maximum Strength Pain Relief 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 00113-0944-24 L. 1 tube $0.045 — Availability likely —
Hemorrhoidal Cream .28 g/28g; 4.032 g/28g; .07 g/28g; 4.2 g/28g 70000-0425-01 Cardinal 1 tube $0.085 — Availability likely —
GNP Hemorrhoidal Maximum Strength 150 mg/g; 144 mg/g; 10 mg/g; 25 mg/g 46122-0776-37 Amerisourcebergen 1 tube $0.130 — Availability likely —
Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g 00363-0641-09 Walgreens 1 tube — — FDA listed —
Hemorrhoidal Pain Relief Cream 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 00363-9127-01 WALGREENS 1 tube — — FDA listed —
PREPARATION H Maximum Strength 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/gthis 00573-2868-10 Haleon 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 11822-2944-00 Rite 1 tube — — Discontinued —
Hemorrhoidal Pain Relief 10 mg/g; 2.5 mg/g; 144 mg/g; 150 mg/g 13709-0335-01 Neilmed 1 tube — — FDA listed —
Signature Care Hemorrhoidal Cream (with applicator) 2.5 mg/g; 10 mg/g; 144 mg/g; 150 mg/g 21130-0981-02 BETTER 1 tube — — FDA listed —
hemorrhoidal maximum strength pain relief 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 30142-0944-24 Kroger 1 tube — — FDA listed —
topcare hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 36800-0944-24 Topco 1 tube — — FDA listed —
Equaline Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 41163-0944-24 United 1 tube — — FDA listed —
hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 41250-0944-24 Meijer 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 42507-0944-24 HyVee 1 tube — — FDA listed —
equate hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 49035-0944-24 Wal-Mart 1 tube — — FDA listed —
Nikzon Hemorrhoidal 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/g 50066-0010-09 Genomma 1 tube — — FDA listed —
CVS Maximum OTC Strength Hemorrhoidal with Aloe 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 51316-0203-01 CVS 28 g — — FDA listed —
Family Wellness HEMORRHOID 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 55319-0981-25 FAMILY 1 tube — — FDA listed —
Family Wellness 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 55621-0012-01 Zhejiang 1 tube — — FDA listed —
hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 56062-0944-24 Publix 1 tube — — FDA listed —
Hemorrhoidal 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 59779-0944-24 CVS 1 tube — — FDA listed —
Hemorrhoidal Cream 1 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 69396-0033-18 Trifecta 1 tube — — FDA listed —
Hemorrhoidal Cream 1 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 69396-0171-18 Trifecta 1 tube — — FDA listed —
Family Wellness 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 69571-0004-02 FRONT 1 tube — — FDA listed —
CVS Health Hemorrhoidal Cream 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 69571-0010-28 FRONT 1 tube — — FDA listed —
Thera Plus Hemorrhoidal 144 mg/g; 150 mg/g; 2.5 mg/g; 10 mg/g 80684-0141-00 FOURSTAR 26 g — — FDA listed —
Thera Plus Hemorrhoidal 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 80684-0210-01 Fourstar 26 g — — FDA listed —
Up and Up Hemorrhoid MAX STRENGTH 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g 82442-0025-51 Target 1 tube — — FDA listed —
Hemorrhoidal Cream with Aloe 15 g/100g; .25 g/100g; 1 g/100g; 14.4 g/100g 83324-0044-09 Chain 1 tube — — FDA listed —
Maximum Strength Hemorrhoidal Cream with Aloe 15 g/100g; .25 g/100g; 1 g/100g; 14.4 g/100g 83324-0330-01 Chain 1 tube — — FDA listed —
Bloop Hemorrhoid Relief Topical 14.4 g/100g; 1 g/100g; 15 g/100g; .25 g/100g 83838-0155-01 Three 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

🏛️
2004
On the market since
Jul 2004
📍
2026
Currently FDA-listed
22 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.

🔬 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 Glycerin, petrolatum, phenylephrine HCl, pramoxine HCl — the ingredient across all brands.

Top reported reactions

Haemorrhage19
Rectal Haemorrhage14
Fatigue13
Diarrhoea11
Haemorrhoids11
Headache10
Pain9

Age at onset

Adult1
Elderly3

Reporter sex

141 reports
Male · 38%
Female · 61%
Unknown · 1%

Serious outcomes

Hospitalization32
Death7
Disabling4
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2025 2026 7 1
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
00573-2868-10 You're viewing this 1 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBE 2004-07-01 Active
00573-2868-20 1 TUBE in 1 CARTON (0573-2868-20) / 51 g in 1 TUBE 2004-07-01 Active
00573-2868-93 1 TUBE in 1 CARTON (0573-2868-93) / 26 g in 1 TUBE 2019-01-01 Active
00573-2868-98 1 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBE 2020-05-12 Active

Pack size FAQ

What quantity is in NDC 00573-2868-10?
NDC 00573-2868-10 is listed by the FDA — 1 tube in 1 carton / 26 g in 1 tube.
What NDC number is used to bill for this package of PREPARATION H Maximum Strength glycerin, petrolatum, phenylephrine HCl, pramoxine HCl 144 mg/g; 2.5 mg/g; 10 mg/g; 150 mg/g Cream?
Bill NDC 00573-2868-10 — the 11-digit billing format is 00573286810. 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 0573-2868-10, 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: 00573-2868-10, written without dashes as 00573286810. 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 00573-2868-10, the first segment (00573) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (2868) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Haleon US Holdings LLC. 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 3 other package presentations of this same product, including 1 tube (00573-2868-20), 1 tube (00573-2868-93), 1 tube (00573-2868-98). 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?
Haleon US Holdings LLC 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 46 words ▾

Uses for temporary relief of pain, soreness and burning helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

⏱️ Dosage and Administration 129 words ▾

Directions Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. when first opening the tube, puncture foil seal with top end of cap apply externally or in the lower portion of the anal canal only apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement for application in the lower anal canal: remove cover from dispensing cap.

Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus. thoroughly cleanse dispensing cap after each use and replace cover children under 12 years of age: ask a doctor

⚠️ Warnings 153 words ▾

Warnings For external use only Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or if 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.

📦 Storage and Handling 6 words ▾

Other information store at 20-25°C (68-77°F)

🧪 Active Ingredient 19 words ▾

Active ingredients Purposes Glycerin 14.4% Protectant Phenylephrine HCl 0.25% Vasoconstrictor Pramoxine HCl 1% Local anesthetic White petrolatum 15% Protectant

🧪 Inactive Ingredients 50 words ▾

Inactive ingredients aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

🎯 Purpose 19 words ▾

Active ingredients Purposes Glycerin 14.4% Protectant Phenylephrine HCl 0.25% Vasoconstrictor Pramoxine HCl 1% Local anesthetic White petrolatum 15% Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00573-2843-01 · Haleon 00573-2871-04 · Haleon →
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.