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Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g Cream — NDC 00363-0641-18 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g Cream — NDC 0363-0641-18 (Billing 00363-0641-18)

by Walgreens · 1 TUBE in 1 PACKAGE / 51 g in 1 TUBE

This is a package of Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g Cream from Walgreens, marketed since Mar 2018 and currently FDA-listed.

NDC 00363-0641-18
🏷️ FDA NDC (as labeled) 0363-0641-18 billing pads the labeler segment with a zero
This package
Contains51 g in 1 tube Pack sizes2 compare ↓
Product page 00363-0641-09 Also comes in: 25.5 g 0363-0641-09
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0363-0641-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0363 labeler · 0641 product · 18 package
Package marketed since
Mar 25, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0311917212999
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-0641-18
Product NDC 0363-0641
11-digit billing NDC 00363064118
RxCUI 1293649
UNII 4T6H12BN9U, PDC6A3C0OX, 88AYB867L5, 04JA59TNSJ
UPC 0311917212999
Application # M015
SPL Set ID 1ac2b2ae-c090-483b-ad2c-1374552add4a
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 2018-03-25
Route TOPICAL
Dosage form CREAM
Substance PETROLATUM; GLYCERIN; PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1293649
Why two NDCs? The FDA registers this code as 0363-0641-18 — 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 → 00363-0641-18. 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.

Clinical

🧪 What is this product?

This is a topical cream marketed as an over-the-counter hemorrhoidal product under FDA's OTC monograph rules. It contains petrolatum and glycerin, which function as moisturizers and protectants for the skin. Pramoxine hydrochloride is a local anesthetic typically used to numb minor pain and itching, while phenylephrine hydrochloride is a decongestant that narrows blood vessels to reduce swelling and discomfort in the affected area.

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 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: 25.5 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
00363-0641-09 0363-0641-09 Main listing 1 TUBE in 1 PACKAGE / 25.5 g in 1 TUBE 2018-03-25 — Active
00363-0641-18 You're viewing this 1 TUBE in 1 PACKAGE / 51 g in 1 TUBE 2018-03-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 package / 51 g in 1 tube.
What NDC number is used to bill for this package of Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/g Cream?
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 Maximum Strength Pain Relief 14.4 g/100g; .25 g/100g; 1 g/100g; 15 g/100g 00113-0944-24 L. 1 tube $0.046 — Availability likely —
Hemorrhoidal Cream .28 g/28g; 4.032 g/28g; .07 g/28g; 4.2 g/28g 70000-0425-01 Cardinal 1 tube $0.084 — Availability likely —
GNP Hemorrhoidal Maximum Strength 150 mg/g; 144 mg/g; 10 mg/g; 25 mg/g 46122-0776-37 Amerisourcebergen 1 tube $0.131 — Availability likely —
Hemorrhoidal Cream 150 mg/g; 144 mg/g; 10 mg/g; 2.5 mg/gthis 00363-0641-18 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/g 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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 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 V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statesAloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

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

LabelerWalgreens
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio342 products on file

More NDCs from Walgreens labeler code 00363

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 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 64 words ▾

Directions Apply externally or in the lower portion of the anal canal only. Apply 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. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 6 words ▾

Other information store at 20-25oC (68-77oF)

🧪 Active Ingredient 13 words ▾

Active Ingredients Glycerin 14.4% Phenylephrine HCL 0.25% Pramoxine HCl 1% White petrolatum 15%

🧪 Inactive Ingredients 34 words ▾

Inactive ingredients Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

🎯 Purpose 6 words ▾

Purpose Protectant Vasoconstrictor Local anasthetic Protectant

📄 Do Not Use 31 words ▾

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

📄 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.

📄 Stop Use and Ask a Doctor If 41 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

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

📖 Instructions for Use 128 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 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.

Lubrcate 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.

📄 Package Label / Principal Display Panel 8 words ▾

Carton label carton label

Tube label Tube 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 Hemorrhoidal Cream — the ingredient across all brands.

Top reported reactions

Anaemia1
Anorectal Discomfort1
Burning Sensation1
Chills1
Depression1
Diarrhoea1
Dyschezia1

Reporter sex

3 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization1
Life-threatening1
Disabling1
Death1
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
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 Walgreens. 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 1 other package presentation of this same product, including 1 tube (00363-0641-09). 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?
Walgreens 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.
← 00363-0640-08 · Walgreen 00363-0646-01 · Walgreen →
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.