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PREPARATION H Phenylephrine hydrochloride 6.25 mg Suppository, 48 suppositories — NDC 00573-1378-00 package photo

PREPARATION H Phenylephrine hydrochloride 6.25 mg Suppository, 48 suppositories

by Haleon US Holdings LLC · 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK
NDC 00573-1378-00
🏷️ FDA NDC (as labeled) 0573-1378-00 billing pads the labeler segment with a zero
This package
Contains48 suppositories Pack sizes3 compare ↓
Also comes in: 12 suppositories 00573-1378-01 24 suppositories 00573-1378-06
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) 0573-1378-00
Product NDC 0573-1378
11-digit billing NDC 00573137800
NCPDP billing unit EA — each (per item)
UNII 04JA59TNSJ
Application # M015
SPL Set ID 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-16
Route RECTAL
Dosage form SUPPOSITORY
Substance PHENYLEPHRINE HYDROCHLORIDE
GCN Seq No 021729
GCN 88861
HICL code 002087
Ingredient (HICL) Phenylephrine 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 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name PREPARATION H 0.25% SUPPOSITRY
FDB brand name Preparation H
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0573-1378-00 — 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 → 00573-1378-00. 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.

🏭 Manufacturer & labeler

LabelerHaleon US Holdings LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00573
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio405 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 0.25% SUPPOSITRY Ingredient Phenylephrine Hcl
📗 Our plain-language guide HelloPharmacist
  • Yes, it's the same active ingredient, but used in very different ways depending on the form. The nasal spray delivers a tiny amount directly to the nasal lining to temporarily shri...
  • I see phenylephrine in nasal sprays at the pharmacy AND as an IV drug in the hospital — is it really the same medication?
  • You should check with your doctor first. Phenylephrine constricts blood vessels, which can raise blood pressure and put extra strain on the heart — even from a nasal spray. If you...
  • Can I use the nasal spray if I have high blood pressure or heart disease?
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →
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 yellow
ShapeBullet
Size32 mm
ScoringNot scored
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

💲 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.
Try another pack size: 12 suppositories 24 suppositories
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
Preparation H 6.25 mgthis 00573-1378-00 Haleon 48 suppositories — — FDA listed —
Phenylephrine Hemorrhoidal 5 mg/2g 13709-0330-01 Neilmed 2 g — — FDA listed —
Bliss GVS Hemorrhoidal 2493.75 mg/1; 6.25 mg 72701-0110-12 Bliss 12 suppositories — — FDA listed —
ReVIVOL-XR 6.25 mg 43749-0432-01 Unipack 24 suppositories — — FDA listed —
Preparation H 6.25 mg 00573-2919-12 Haleon 12 suppositories — — FDA listed —
up and up 6.25 mg 82442-0060-12 Target 12 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00573-1378-00 You're viewing this 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK 2022-12-16 Active
00573-1378-01 12 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACK 2022-12-16 Active
00573-1378-06 24 BLISTER PACK in 1 CARTON (0573-1378-06) / 1 SUPPOSITORY in 1 BLISTER PACK 2022-12-16 Active

Pack size FAQ

What quantity is in NDC 00573-1378-00?
NDC 00573-1378-00 contains 48 suppositories — 48 blister pack in 1 carton / 1 suppository in 1 blister pack.
What is the difference between NDC 00573-1378-00 and NDC 00573-1378-01?
Both are PREPARATION H Phenylephrine hydrochloride 6.25 mg Suppository — the drug itself is identical. NDC 00573-1378-00 is the 48 suppositories package, while NDC 00573-1378-01 is the 12 suppositories package.
What NDC number is used to bill for this package of PREPARATION H Phenylephrine hydrochloride 6.25 mg Suppository?
Bill NDC 00573-1378-00 — the 11-digit billing format is 00573137800. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 0573-1378-00, 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: 00573-1378-00, written without dashes as 00573137800. 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 00573-1378-00, the first segment (00573) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (1378) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 2 other package presentations of this same product, including 12 suppositories (00573-1378-01), 24 suppositories (00573-1378-06). 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders

⏱️ Dosage and Administration 139 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 the 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 the 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: consult a doctor Directions Opening Guide 01 Directions Opening Guide 02

⚠️ Warnings 115 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.

🧪 Active Ingredient 5 words ▾

Active ingredient Phenylephrine HCl 0.25%

🧪 Inactive Ingredients 8 words ▾

Inactive ingredients cocoa butter, corn starch, methylparaben, propylparaben

🎯 Purpose 2 words ▾

Purpose Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00573-1174-12 · Haleon 00573-1711-14 · 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.