Home › NDC Lookup › Ingredients › Mineral Oil, Petrolatum, Phenylephrine H... › 52000-0438-02
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL Mineral Oil, Petrolatum, Phenylephrine Hydrochloride 14 g/100g; 74.9 g/100g; .25 g/100g Ointment — NDC 52000-0438-02 package photo

0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL Mineral Oil, Petrolatum, Phenylephrine Hydrochloride 14 g/100g; 74.9 g/100g; .25 g/100g Ointment

by Universal Distribution Center LLC · 1 TUBE in 1 BOX (52000-438-02) / 57 g in 1 TUBE
NDC 52000-0438-02
🏷️ FDA NDC (as labeled) 52000-438-02 billing pads the product segment with a zero
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) 52000-438-02
Product NDC 52000-438
11-digit billing NDC 52000043802
RxCUI 1372298
UNII T5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Application # M015
SPL Set ID 90844919-f16a-4390-9dca-b0405b501445
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 2026-01-19
Route TOPICAL
Dosage form OINTMENT
Substance MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 52000-438-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52000-0438-02. 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 Softeners, emollients class.

Drug family (ATC) Softeners, emollients
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

LabelerUniversal Distribution Center LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code52000
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio92 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

🧪 What is this product?

This is an over-the-counter hemorrhoidal ointment applied topically to the skin. Phenylephrine hydrochloride is a decongestant that functions to narrow blood vessels in the area where it is applied. Mineral oil and petrolatum are emollients and lubricants commonly included in topical products to soften the area and ease discomfort. This product is an OTC monograph drug, meaning it is marketed under established FDA guidelines for this category rather than as an individually approved application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesbeeswax, ceteareth-20, cetostearyl alcohol, glycerin

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.
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 14 g/100g; 74.9 g/100g; .25 g/100g 00113-0188-16 L. 1 tube $0.054 — Availability likely —
Hemorrhoidal .25 g/100g; 14 g/100g; 74.9 g/100g 00536-1288-06 Rugby 1 tube $0.054 — Availability likely —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 45802-0188-16 Padagis 1 tube $0.054 — Availability likely —
GNP Hemorrhoidal 2.5 mg/g; 749 mg/g; 140 mg/g 46122-0677-46 Amerisource 1 tube $0.054 — Availability likely —
Hemorrhoidal .25 g/100g; 14 g/100g; 74.9 g/100g 70000-0046-01 Cardinal 1 tube $0.054 — Availability likely —
foster and thrive hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 70677-1108-01 Strategic 1 tube $0.054 — Availability likely —
Walgreens 2.5 mg/g; 140 mg/g; 749 mg/g 00363-6503-01 Walgreens 1 tube — — FDA listed —
Hemorrhoidal Pain Relief 2.5 mg/g; 140 mg/g; 749 mg/g 00363-9876-02 WALGREENS 1 tube — — FDA listed —
Preparation H 2.5 mg/g; 140 mg/g; 749 mg/g 00573-2871-04 Haleon 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 11822-0006-00 Rite 1 tube — — Discontinued —
Hemorrhoidal 2.5 mg/g; 749 mg/g; 140 mg/g 13709-0319-01 NeilMed 1 tube — — FDA listed —
Hemorrhoidal Pain Relief 749 mg/g; 140 mg/g; 2.5 mg/g 13709-0334-01 Neilmed 1 tube — — FDA listed —
signature care hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 21130-0577-16 Safeway 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 21130-0687-16 Safeway 1 tube — — FDA listed —
Signature Care Hemorrhoidal 749 mg/g; 2.5 mg/g; 140 mg/g 21130-0789-14 Better 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 30142-0188-16 Kroger 1 tube — — FDA listed —
topcare hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 36800-0499-16 Topco 1 tube — — FDA listed —
Equaline Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 41163-0188-16 United 1 tube — — FDA listed —
hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 41250-0188-16 Meijer 1 tube — — FDA listed —
careone hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 41520-0188-16 American 1 tube — — FDA listed —
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL 14 g/100g; 74.9 g/100g; .25 g/100g 43473-0094-02 Nantong 1 tube — — FDA listed —
Equate Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 49035-0188-16 Wal-Mart 1 tube — — FDA listed —
Hemorrhoidal 140 mg/g; 749 mg/g; 2.5 mg/g 51316-0228-01 CVS 1 tube — — FDA listed —
CAREALL Hemorrhoidal 140 mg/g; 749 mg/g; 2.5 mg/g 51824-0079-02 New 56 g — — FDA listed —
Hemorrhoid Anesthetic .14 g/g; .749 g/g; .0025 g/g 52000-0057-01 Universal 1 tube — — Discontinued —
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL 14 g/100g; 74.9 g/100g; .25 g/100gthis 52000-0438-02 Universal 1 tube — — FDA listed —
Exchange Select Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 55301-0188-16 Army 1 tube — — FDA listed —
Family Wellness Hemorrhoidal 749 mg/g; 140 mg/g; 2.5 mg/g 55319-0381-56 Family 1 tube — — FDA listed —
TheraPlus Plus .25 g/100g; 14 g/100g; 74.9 g/100g 55621-0005-01 Zhejiang 42 g — — FDA listed —
Family Wellness .25 g/100g; 14 g/100g; 74.9 g/100g 55621-0006-01 Zhejiang 1 tube — — FDA listed —
ProCure Hemorrhoidal 74.9 g/100g; .25 g/100g; 14 g/100g 55681-0021-02 Twin 56.6 g — — FDA listed —
DG Health Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 55910-0188-16 Dolgencorp, 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 56062-0188-16 Publix 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 63187-0505-02 Proficient 1 tube — — FDA listed —
HemorrhoidalOintment 14 g/100g; 74.9 g/100g; .25 g/100g 68016-0528-00 Pharmacy 1 tube — — FDA listed —
HemorrhoidalOintment 14 g/100g; 74.9 g/100g; .25 g/100g 69396-0020-01 Trifecta 1 tube — — FDA listed —
HemorrhoidalOintment 14 g/100g; 74.9 g/100g; .25 g/100g 69396-0082-02 Trifecta 1 tube — — FDA listed —
HemorrhoidalOintment 74.9 g/100g; .25 g/100g; 14 g/100g 69396-0083-01 Trifecta 1 tube — — FDA listed —
HemorrhoidalOintment 14 g/100g; 74.9 g/100g; .25 g/100g 69396-0133-20 Trifecta 1 tube — — FDA listed —
hemorrhoidal 749 mg/g; 2.5 mg/g; 140 mg/g 69452-0448-38 Bionpharma 1 tube — — FDA listed —
Family wellness 14 g/100g; 74.9 g/100g; .25 g/100g 69571-0006-02 FRONT 1 tube — — FDA listed —
TheraCare Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 71101-0935-01 Veridian 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 72162-2282-02 Bryant 1 tube — — FDA listed —
Basic Care Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 72288-0188-16 Amazon.com 1 tube — — FDA listed —
Hemorrhoidal .25 g/100g; 14 g/100g; 74.9 g/100g 83324-0045-02 Chain 1 tube — — FDA listed —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 85766-0140-57 Sportpharm 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
52000-0438-02 You're viewing this 1 TUBE in 1 BOX (52000-438-02) / 57 g in 1 TUBE 2026-01-19 Active

🧭 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 52000-438-02, 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: 52000-0438-02, written without dashes as 52000043802. 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 52000-0438-02, the first segment (52000) is the labeler code FDA assigned to Universal Distribution Center LLC; the middle segment (0438) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Universal Distribution Center LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Universal Distribution Center 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 44 words ▾

Uses helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue and relieves burning • 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 126 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 ointment • when first opening the tube, puncture foil seal secured on tube • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum • thoroughly cleanse applicator after each use and replace cover • also apply ointment to external area • regular use provides continual therapy for relief of symptoms • children under 12 years of age: ask a doctor.

⚠️ Warnings 133 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 Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding , ask a healthcare 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 18 words ▾

Other information ​• store at 20°–25°C (68°–77°F) • do not use if tube seal under cap is broken

🧪 Active Ingredient 10 words ▾

Active ingredient Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCl 0.25%

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients beeswax, ceteareth-20, cetostearyl alcohol, glycerin

🎯 Purpose 4 words ▾

Purpose Protectant Protectant Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52000-0437-08 · Universal 52000-0439-25 · Universal →
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.