Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL .14 g/g; .749 g/g; .0025 g/g Ointment — NDC 52000-0057-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL .14 g/g; .749 g/g; .0025 g/g Ointment — NDC 52000-057-01 (Billing 52000-0057-01)

by Universal Distribution Center LLC · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL .14 g/g; .749 g/g; .0025 g/g Ointment from Universal Distribution Center LLC, no longer marketed (first marketed Dec 2020), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 52000-0057-01
🏷️ FDA NDC (as labeled) 52000-057-01 billing pads the product segment with a zero
This package
Contains28 g in 1 tube Pack sizes2 compare ↓
Main listing for product 52000-057 · Also comes in: 28 g 52000-057-02
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52000-057-01
Product NDC 52000-057
11-digit billing NDC 52000005701
RxCUI 1372298
UNII T5L8T28FGP, 4T6H12BN9U, 04JA59TNSJ
Application # M015
SPL Set ID 5307f349-a25c-4fd4-b588-38832d401192
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Marketing start 2020-12-09
Route TOPICAL
Dosage form OINTMENT
Substance MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1372298
Why two NDCs? The FDA registers this code as 52000-057-01 — 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 → 52000-0057-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical ointment marketed under FDA guidelines for hemorrhoid relief. Mineral oil and petrolatum function as lubricants and emollients to soften stools and ease discomfort. Phenylephrine hydrochloride is a decongestant that is typically used to reduce swelling and shrink inflamed tissue in the affected area. The product is applied directly to external hemorrhoids as directed on the label.

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 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: 28 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52000-0057-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2020-12-09 — Inactivated by FDA
52000-0057-02 52000-057-02 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2020-12-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 28 g in 1 tube.
What NDC number is used to bill for this package of Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL .14 g/g; .749 g/g; .0025 g/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 $0.057 — Availability likely —
Hemorrhoidal .25 g/100g; 14 g/100g; 74.9 g/100g 00536-1288-06 Rugby 1 tube $0.057 — Availability likely —
Hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 45802-0188-16 Padagis 1 tube $0.057 — Availability likely —
GNP Hemorrhoidal 2.5 mg/g; 749 mg/g; 140 mg/g 46122-0677-46 Amerisource 1 tube $0.057 — Availability likely —
Hemorrhoidal .25 g/100g; 14 g/100g; 74.9 g/100g 70000-0046-01 Cardinal 1 tube $0.057 — Availability likely —
foster and thrive hemorrhoidal 14 g/100g; 74.9 g/100g; .25 g/100g 70677-1108-01 Strategic 1 tube $0.057 — 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/gthis 52000-0057-01 Universal 1 tube — — Discontinued —
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL 14 g/100g; 74.9 g/100g; .25 g/100g 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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.

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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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 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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII 884C3FA9HE
    Lanolin alcohol is a waxy substance derived from sheep's wool. It functions as an emollient and emulsifier in medicines, helping blend oil and water-based ingredients while softening the product's texture.
  • 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 I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • 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 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.

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

The official label also statesInactive Ingredients benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, tocopherol acetate, yellow wax.

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

LabelerUniversal Distribution Center LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code52000
First marketedDec 2020
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.

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 21 words ▾

Uses For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

⏱️ Dosage and Administration 57 words ▾

Directions Cleanse the affected area with mild soap and warm water, rinse thoroughly. Dry by patting or blotting with toilet tissue or soft cloth before applying this product. Cover the entire affected area with a thin layer 1 to 3 times daily. Children under 12 years of age need to consult a doctor before using this product.

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 10 words ▾

Active Ingredients Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCL 0.25%

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, tocopherol acetate, yellow wax.

🎯 Purpose 4 words ▾

Purpose Protectant Protectant Vasoconstrictor

📄 Stop Use and Ask a Doctor If 98 words ▾

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. If you are pregnant, do not use this product without first consulting a doctor.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If ingested seek medical attention immediately or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 16 words ▾

PRINCIPAL DISPLAY PANEL Hemorrhoid Anesthetic Ointment NET WT. 1 OZ. (28 g) image of package label

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 Mineral Oil, Petrolatum, Phenylephrine HCL — the ingredient across all brands.

Top reported reactions

Haemorrhage18
Fatigue17
Rectal Haemorrhage14
Diarrhoea13
Haemorrhoids12
Pain12
Nausea11

Age at onset

Adult7
Elderly9

Reporter sex

176 reports
Male · 40%
Female · 59%
Unknown · 1%

Serious outcomes

Hospitalization44
Death12
Life-threatening5
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (52000-0057-02). 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?
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.
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.