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Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief Selenium Sulfide 1 g/100mL Lotion/Shampoo, 400 mL — NDC 69423-0526-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief Selenium Sulfide 1 g/100mL Lotion/Shampoo, 400 mL — NDC 69423-526-40 (Billing 69423-0526-40)

by The Procter & Gamble Manufacturing Company · 400 mL in 1 BOTTLE, PLASTIC

This is a package of 400 mL of Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief Selenium Sulfide 1 g/100mL Lotion/Shampoo from The Procter & Gamble Manufacturing Company, marketed since Nov 2020 and currently FDA-listed, this package's marketing is listed to end Dec 2026.

NDC 69423-0526-40
🏷️ FDA NDC (as labeled) 69423-526-40 billing pads the product segment with a zero
This package
Contains400 mL Pack sizes2 compare ↓
Product page 69423-0526-01 Also comes in: 2 bottles 69423-526-01
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

NDC database record

One package, one record: these facts belong to NDC 69423-526-40 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69423 labeler · 526 product · 40 package
Package marketed since
Nov 17, 2020
Package marketing ended
Dec 1, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 6942352640 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69423-526-40
Product NDC 69423-526
11-digit billing NDC 69423052640
RxCUI 204642, 1549328
UNII Z69D9E381Q
Application # M032
SPL Set ID b6ad7707-9d02-31a6-e053-2a95a90ae7ad
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-17
Marketing end 2026-12-01
Route TOPICAL
Dosage form LOTION/SHAMPOO
Substance SELENIUM SULFIDE
Quick answers
  • RxCUI (RxNorm): 204642
Why two NDCs? The FDA registers this code as 69423-526-40 — 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 → 69423-0526-40. 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.
Try another pack size: 2 bottles
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
69423-0526-01 69423-526-01 Main listing 2 BOTTLE, PLASTIC in 1 CELLO PACK / 400 mL in 1 BOTTLE, PLASTIC 2023-01-17 Dec 1, 2026 Active
69423-0526-40 You're viewing this 400 mL in 1 BOTTLE, PLASTIC 2020-11-17 Dec 1, 2026 Active

Pack size FAQ

What quantity is in this package?
This package contains 400 mL — 400 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief Selenium Sulfide 1 g/100mL Lotion/Shampoo?
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
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/mL 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/100mLthis 69423-0526-40 The 400 ml — — 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

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

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 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 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 X3W0AM1JLX
    A synthetic red dye used to color medicines and products. It helps make pills, liquids, and capsules visually distinct and easier to identify.
  • 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 1AEY1M553N
    A natural oil extracted from spearmint or field mint leaves, used as a flavoring agent to give medicines a minty taste and aroma. It may also provide a cooling sensation in topical products.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII G4LZF950UR
    Sodium xylenesulfonate is a synthetic organic salt used as a solubilizer and buffering agent in liquid medications. It helps dissolve active ingredients that don't mix well with water, improving how the medicine can be formulated and absorbed.
  • 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.

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

The official label also statesWater, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.

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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedNov 2020
Product typeHuman Otc Drug
Portfolio850 products on file

More NDCs from The Procter & Gamble Manufacturing Company labeler code 69423

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 📄 Ask a Doctor Before Use If 📄 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 17 words ▾

Uses helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

⏱️ Dosage and Administration 51 words ▾

Directions for best results use at least twice a week or as directed by a doctor. for maximum dandruff control, use every time you shampoo. shake before use. wet hair, massage onto scalp, rinse, repeat if desired. caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.

⚠️ Warnings 79 words ▾

Warnings For external use only. Ask a doctor before use if you have a condition that covers a large area of the body. avoid contact with 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 this and all drugs 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 35 words ▾

Inactive ingredients Water, sodium lauryl sulfate, glycol distearate, sodium chloride, cocamidopropyl betaine, sodium citrate, sodium xylenesulfonate, dimethicone,menthol, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, hydroxypropyl methylcellulose, mentha piperita (peppermint) oil,mentha arvensis leaf oil, red 4.

🎯 Purpose 4 words ▾

Purpose Anti-dandruff, anti-seborrheic dermatitis

📄 Ask a Doctor Before Use If 18 words ▾

Ask a doctor before use if you have a condition that covers a large area of the body.

📄 When Using This Product 12 words ▾

avoid contact with 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 23 words ▾

Keep this and all drugs 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)? 1-800-723-9569

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL head & shoulders ® selenium sulfide dandruff & seborrheic dermatitis shampoo Clinical Strength Dandruff Defense Intensive Itch Relief

13.5 FL OZ (400 mL) HS

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.

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 it is currently marketed — but The Procter & Gamble Manufacturing Company has reported a marketing end date of 2026-12-01, after which this package is expected to stop being marketed. 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 2 bottles (69423-0526-01). 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?
The Procter & Gamble Manufacturing 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.
← 69423-0525-40 · The 69423-0527-40 · The →
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.