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Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis Selenium Sulfide 10 mg/mL Shampoo, 400 mL — NDC 00363-9422-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis Selenium Sulfide 10 mg/mL Shampoo, 400 mL — NDC 0363-9422-01 (Billing 00363-9422-01)

by Walgreen Company · 400 mL in 1 BOTTLE, PLASTIC

This is a package of 400 mL of Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis Selenium Sulfide 10 mg/mL Shampoo from Walgreen Company, marketed since Dec 2016 and currently FDA-listed. It is this product's only package size.

NDC 00363-9422-01
🏷️ FDA NDC (as labeled) 0363-9422-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0363-9422-01
Product NDC 0363-9422
11-digit billing NDC 00363942201
RxCUI 204642
UNII Z69D9E381Q
Application # M032
SPL Set ID cc83427d-49e6-4a20-9d03-9ec8ce27e487
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-12-14
Route TOPICAL
Dosage form SHAMPOO
Substance SELENIUM SULFIDE
Quick answers
  • RxCUI (RxNorm): 204642
Why two NDCs? The FDA registers this code as 0363-9422-01 — 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 → 00363-9422-01. 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 Other antifungals for topical use class.

Drug family (ATC) Other antifungals 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 it is MedlinePlus · NLM

Selenium sulfide, an anti-infective agent, relieves itching and flaking of the scalp and removes the dry, scaly particles that are commonly referred to as dandruff or seborrhea. It is also used to treat tinea versicolor, a fungal infection of the skin. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used on the scalp to relieve flaking and itching from dandruff and seborrheic dermatitis. It also helps keep those problems from coming back. Some products also list relief of...
  • Most labels say to use it at least twice a week for best results, or as your doctor directs. Some say you can use it every time you shampoo for maximum control. Check your own prod...
  • Some people get skin irritation, or oily or dry hair and scalp. Hair discoloration and a bit more hair shedding have been reported occasionally. Rinsing thoroughly after use helps...
  • Keep it out of your eyes and away from the genital area, since it can cause irritation and burning. Don't use it on broken or inflamed skin. If you get it in your eyes, rinse well...
📖 Read our full Selenium Sulfide guide →

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.
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
00363-9422-01 You're viewing this Main listing 400 mL in 1 BOTTLE, PLASTIC 2016-12-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Anti-Dandruff 10 mg/mL 00536-1995-53 Rugby 207 ml $0.014 — Availability likely —
Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff 10 mg/mL 70000-0531-01 Cardinal 207 ml $0.014 — Availability likely —
Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruff 10 mg/mL 00363-4136-01 Walgreen 325 ml — — FDA listed —
Walgreens Dandruff Maximum Strength Anti-dandruff 10 mg/mL 00363-4139-01 Walgreen 325 ml — — FDA listed —
Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 10 mg/mL 00363-4902-01 Walgreen 325 ml — — FDA listed —
Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis 10 mg/mLthis 00363-9422-01 Walgreen 400 ml — — FDA listed —
Dandruff 10 mg/mL 37808-0816-15 H 420 ml — — FDA listed —
Selsun Blue 2-in-1 1 g/100mL 41167-1651-04 Chattem, 325 ml — — FDA listed —
Selsun Blue Itchy Dry Scalp .01 g/mL 41167-6020-03 Chattem, 325 ml — — FDA listed —
Selsun Blue Moisturizing 1 g/100mL 41167-6032-00 Chattem, 207 ml — — FDA listed —
Selsun Blue Medicated 1 g/100mL 41167-6061-01 Chattem, 325 ml — — FDA listed —
Meijer Medicated Selenium Sulfide Anti-Dandruff 10 mg/mL 41250-0545-01 Meijer 325 ml — — FDA listed —
Dandruff 10 mg/mL 41250-0816-15 Meijer, 420 ml — — FDA listed —
Equate Medicated Dandruff Anti-Dandruff 10 mg/mL 49035-0534-01 Wal-Mart 325 ml — — FDA listed —
GoodSense Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff 10 mg/mL 50804-0883-01 GOODSENSE 325 ml — — FDA listed —
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff 10 mg/mL 51316-0387-01 CVS 325 ml — — FDA listed —
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruff 10 mg/mL 51316-0719-01 CVS 325 ml — — FDA listed —
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 10 mg/mL 55319-0949-01 FAMILY 325 ml — — FDA listed —
CVS Gold 1000 mg/100mL 63148-0209-13 Apollo 400 ml — — FDA listed —
Head and Shoulders Clinical Strength Dandruff Defense Dry Scalp Rescue 1 g/100mL 69423-0523-40 The 400 ml — — FDA listed —
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control 1 g/100mL 69423-0525-40 The 400 ml — — Discontinued —
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief 1 g/100mL 69423-0526-01 The 2 bottles — — FDA listed —
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch Relief 1 g/100mL 69423-0527-40 The 400 ml — — FDA listed —
Head and Shoulders Clinical Strength Dandruff Defense Sensitive Scalp 1 g/100mL 69423-0642-40 The 400 ml — — Discontinued —
Prosoria Medicated 1.77 g/177mL 71573-0121-12 Nuvothera, 177 ml — — FDA listed —
amazon basics maximum strength dandruff Anti-dandruff 10 mg/mL 72288-0551-01 AMAZON.COM 325 ml — — FDA listed —
Careone Medicated Dandruff 10 mg/mL 72476-0025-03 Retail 325 ml — — FDA listed —
Topco Associates 10 mg/mL 76162-0171-11 Topco 325 ml — — FDA listed —
meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 10 mg/mL 79481-0071-01 Meijer 325 ml — — FDA listed —
up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 10 mg/mL 82442-0308-01 TARGET 355 ml — — FDA listed —
up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 10 mg/mL 82442-0384-01 TARGET 355 ml — — FDA listed —
Dermoia Seborrheic Dermatitis Selenium Sulfide 10 mg/mL 83524-0938-00 TREASUREWISE 355 ml — — FDA listed —
Head and Shoulders Clinical Strength Advanced Oil Control 1 g/100mL 84126-0075-01 The 2 bottles — — FDA listed —
Head and Shoulders 2in1 Clinical Strength Dry Scalp Rescue 1 g/100mL 84126-0083-40 The 400 ml — — FDA listed —
Head and Shoulders Clinical Strength Dry Scalp Rescue 1 g/100mL 84126-0108-01 The 2 bottles — — FDA listed —
Head and Shoulders Clinical Strength Cooling Itch Relief 1 g/100mL 84126-0183-01 The 2 bottles — — FDA listed —
Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief 1 g/100mL 84126-0184-40 The 400 ml — — FDA listed —
Seleniumdisulfideanti-Dandruffshampoo 1 g/100g 84778-0080-01 Guangzhou 300 g — — Discontinued —
Easyes Anti Dandruff And Anti Hair Thinning Shamp00 1 g/100mL 85004-0002-01 Qingyuan 200 ml — — FDA listed —
UCHOIZE S2 Balance Anti-Dandruff 1 g/100mL 85724-0001-01 Dreamwise 280 ml — — FDA listed —
Silvagle Selenium Sulfide Anti DandruffShampoo 1 mg/100mg 87806-0001-01 GUANGZHOU 300 mg — — 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

🏛️
2016
On the market since
Dec 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 orange
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 43ZIH89I48
    Ammonium laureth-5 sulfate is a surfactant derived from coconut oil. It helps clean and remove oils in topical products and aids in mixing water and oil-based ingredients together in formulations.
  • UNII Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • UNII 4FZY6L6XCM
    A synthetic compound derived from xylenol and ammonia. It functions as a solubilizing agent and surfactant, helping dissolve poorly water-soluble active ingredients and improve their absorption in the body.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII 229D0E1QFA
    Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 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.

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

The official label also stateswater, ammonium laureth sulfate, cocamidopropyl betaine, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, cetyl alcohol, stearyl alcohol, hydroxypropyl methylcellulose, dimethicone, sodium benzoate, fragrance, sodium citrate, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, citric acid, sodium chloride, red 40.

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

LabelerWalgreen Company
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedDec 2016
Product typeHuman Otc Drug
Portfolio468 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses Helps prevent recurrence of scalp itching and flaking associated with dandruff and seborrheic dermatitis.

⏱️ Dosage and Administration 36 words ▾

Directions shake well. wet hair. massage onto scalp. rinse. repeat if desired. for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo.

⚠️ Warnings 78 words ▾

Warnings For external use only If condition covers a large area of the body, consult your doctor before using this product. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed 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 Selenium Sulfide 1%

🧪 Inactive Ingredients 39 words ▾

Inactive ingredients water, ammonium laureth sulfate, cocamidopropyl betaine, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, cetyl alcohol, stearyl alcohol, hydroxypropyl methylcellulose, dimethicone, sodium benzoate, fragrance, sodium citrate, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, citric acid, sodium chloride, red 40.

🎯 Purpose 4 words ▾

Purpose Anti-dandruff, Anti-seborrheic dermatitis

📄 When Using This Product 17 words ▾

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed

📄 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.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-925-4733

📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label Walgreens Compare to the active ingredient in Head & Shoulders ® Clinical Strength †† • WALGREENS • PHARMACIST RECOMMENDED DANDRUFF SHAMPOO Clinical Strength SELENIUM SULFIDE 1% Medicated Strong medicated formula to help treat dandruff & seborrheic dermatitis 05-3271C

13.5 FL OZ (400 mL) PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Selenium Sulfide (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Selenium Sulfide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$190.8K
Claims incl. refills
12.2K
Beneficiaries
9.2K
Spend / beneficiary
$20.82
Spend / claim
$15.64
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis (this brand).

Top reported reactions

Pain37
Fatigue32
Nausea32
Pruritus29
Anxiety25
Condition Aggravated25
Headache24

Age at onset

Infant1
Child2
Adolescent3
Adult82
Elderly43

Reporter sex

669 reports
Male · 56%
Female · 44%

Serious outcomes

Hospitalization154
Death23
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 57 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
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 Walgreen Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen Company 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.
← 00363-9417-15 · WALGREENS 00363-9425-01 · Walgreens →
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.