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Preparation H cocoa butter, phenylephrine hydrochloride, and witch hazel Kit — NDC 00573-2884-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Preparation H cocoa butter, phenylephrine hydrochloride, and witch hazel Kit — NDC 0573-2884-12 (Billing 00573-2884-12)

by Haleon US Holdings LLC · 1 KIT in 1 CARTON * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR

This is a package of Preparation H cocoa butter, phenylephrine hydrochloride, and witch hazel Kit from Haleon US Holdings LLC, marketed since Jul 2015 and currently FDA-listed. It is this product's only package size.

NDC 00573-2884-12
🏷️ FDA NDC (as labeled) 0573-2884-12 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 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

NDC database record

One package, one record: these facts belong to NDC 0573-2884-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0573 labeler · 2884 product · 12 package
Package marketed since
Jul 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0573288412 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0573-2884-12
Product NDC 0573-2884
11-digit billing NDC 00573288412
RxCUI 844379, 1438497
Application # M015
SPL Set ID 2f370875-0225-47b7-b43f-8fa4600d2a0e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-01
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 844379
Why two NDCs? The FDA registers this code as 0573-2884-12 — 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 → 00573-2884-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Preparation H is an over-the-counter topical kit marketed under FDA's OTC monograph rules for hemorrhoidal products. It contains phenylephrine hydrochloride, a decongestant typically used to reduce swelling and discomfort, along with cocoa butter and witch hazel, which are commonly included in hemorrhoidal formulations for their soothing and astringent properties. This kit is applied directly to the affected area as directed on the package label.

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 eachPer 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
00573-2884-12 You're viewing this Main listing 1 KIT in 1 CARTON * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR 2015-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Hemorrhoidal 2211 mg/1; 6.5 mg 00113-0279-53 L. 12 suppositories $0.288 — Availability likely —
rugby hemorrhoidal 2211 mg/1; 6.5 mg 00536-1186-12 Rugby 12 suppositories $0.288 — Availability likely —
Hemorrhoidal 2.39 g/1; 6.75 mg 46122-0777-65 Amerisourcebergen 12 suppositories $0.288 — Availability likely —
Leader Hemorrhoidal 2211 mg/1; 6.5 mg 70000-0223-01 Cardinal 12 suppositories $0.288 — Availability likely —
foster and thrive hemorrhoidal 2211 mg/1; 6.5 mg 70677-1292-01 Strategic 12 suppositories $0.288 — Availability likely —
Walgreens Hemorrhoidal 2211 mg/1; 6.25 mg 00363-0476-24 Walgreens 24 suppositories — — FDA listed —
Preparation Hthis 00573-2884-12 Haleon 12 suppositories — — FDA listed —
hemorrhoidal relief 2211 mg/1; 6.5 mg 11822-0005-01 Rite 12 suppositories — — FDA listed —
Hemorrhoidal cocoa butter 2.5 mg/g; 884.4 mg/g 13709-0323-01 NeilMed 24 capsules — — FDA listed —
Signature Care Hemorrhoidal 2211 mg/1; 6.5 mg 21130-0628-53 Safeway 12 suppositories — — Discontinued —
hemorrhoidal 2211 mg/1; 6.5 mg 30142-0279-62 Kroger 24 suppositories — — FDA listed —
topcare hemorrhoidal 2211 mg/1; 6.5 mg 36800-0279-53 Topco 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 37808-0279-62 H 24 suppositories — — FDA listed —
Equaline Hemorrhoidal 2211 mg/1; 6.5 mg 41163-0279-53 United 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 41250-0279-62 Meijer 24 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 42507-0279-53 HyVee 12 suppositories — — FDA listed —
equate hemorrhoidal 2211 mg/1; 6.5 mg 49035-0463-62 Wal-Mart 24 suppositories — — FDA listed —
Exchange Select Hemorrhoidal 2211 mg/1; 6.5 mg 55301-0279-62 Army 24 suppositories — — FDA listed —
rexall hemorrhoidal 2211 mg/1; 6.5 mg 55910-0279-53 Dolgencorp 12 suppositories — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 56062-0279-53 Publix 12 suppositories — — FDA listed —
Xyralid Hemorrhoidal 88.5 g/100g; .26 g/100g 57483-0410-13 Innovus 24 g — — FDA listed —
hemorrhoidal 2211 mg/1; 6.5 mg 59779-0279-53 CVS 12 suppositories — — FDA listed —
Hemorrhoidal 1768.8 mg/1; 5 mg 70795-1021-02 GRAXCELL 12 suppositories — — FDA listed —
basic care hemorrhoidal 2211 mg/1; 6.5 mg 72288-0800-62 Amazon.com 24 suppositories — — 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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 yellow / 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.

From the label’s inactive-ingredient sectioncorn starch, methylparaben, propylparaben aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00573
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio405 products on file

More NDCs from Haleon US Holdings LLC labeler code 00573

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 64 words ▾

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily relieves burning and 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

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

⏱️ Dosage and Administration 187 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 insertion of this product. detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: hold suppository with rounded end up as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down" slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository remove exposed suppository from wrapper insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age: ask a doctor Image 1 Image 2

Directions adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area. use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor

⚠️ Warnings 200 words ▾

Warnings For rectal 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 Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days 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.

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 Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days 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 24 words ▾

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

Other information store at 20-25°C (68-77°F) for best results, flush only one or two wipes at a time

🧪 Active Ingredient 16 words ▾

Active Ingredients Cocoa butter 88.44% Phenylephrine HCl 0.25% Purposes Protectant Vasoconstrictor

Active ingredient Witch hazel 50.0%

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients corn starch, methylparaben, propylparaben

Inactive ingredients aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

🎯 Purpose 5 words ▾

Purposes Protectant Vasoconstrictor

Purpose Astringent

📄 Ask a Doctor Before Use If 26 words ▾

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 21 words ▾

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 49 words ▾

When using this product do not exceed the recommended daily dosage unless directed by a doctor

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

📄 Stop Use and Ask a Doctor If 36 words ▾

Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days

Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days

🤰 If Pregnant or Breast-Feeding 20 words ▾

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 38 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 45 words ▾

Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 For most recent product information, visit www.preparationh.com

Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374 . For most recent product information, visit www.preparationh.com.

📄 Package Label / Principal Display Panel 52 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton SAME AMOUNT Smaller Package PREPARATION H ® HEMORRHOIDAL SUPPOSITORIES Provides Relief from MULTIPLE SYMPTOMS Reduces Internal Swelling, Soothes & Protects Prompt Soothing Relief from Painful Burning, Itching and Discomfort Also for Nighttime Relief + 4 FREE WIPES INSIDE 12 SUPPOSITORIES Principal Display Panel - Kit Carton

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

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 Cocoa butter, phenylephrine hydrochloride, and witch hazel — the ingredient across all brands.

Top reported reactions

Haemorrhage18
Fatigue13
Rectal Haemorrhage12
Diarrhoea11
Haemorrhoids9
Headache9
Pain8

Age at onset

Adult1
Elderly3

Reporter sex

127 reports
Male · 37%
Female · 63%
Unknown · 1%
Reports over time (by year) — tap or hover for the count & year
2024 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 00573-2883-10 · Haleon 00573-2890-01 · 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.