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Mielle Lavender and Lychee Scalp Soothing Daily Refresher Pyrithione Zinc .1 g/100mL Lotion, 118 mL — NDC 84126-0257-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mielle Lavender and Lychee Scalp Soothing Daily Refresher Pyrithione Zinc .1 g/100mL Lotion, 118 mL — NDC 84126-257-11 (Billing 84126-0257-11)

by The Procter & Gamble Manufacturing Company · 118 mL in 1 BOTTLE, PUMP

This is a package of 118 mL of Mielle Lavender and Lychee Scalp Soothing Daily Refresher Pyrithione Zinc .1 g/100mL Lotion from The Procter & Gamble Manufacturing Company, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 84126-0257-11
🏷️ FDA NDC (as labeled) 84126-257-11 billing pads the product 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

NDC database record

One package, one record: these facts belong to NDC 84126-257-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84126 labeler · 257 product · 11 package
Package marketed since
Mar 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8412625711 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84126-257-11
Product NDC 84126-257
11-digit billing NDC 84126025711
RxCUI 1052676
UNII R953O2RHZ5
Application # M032
SPL Set ID 51033795-843b-844a-e063-6394a90ad091
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-01
Route TOPICAL
Dosage form LOTION
Substance PYRITHIONE ZINC
Quick answers
  • RxCUI (RxNorm): 1052676
Why two NDCs? The FDA registers this code as 84126-257-11 — 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 → 84126-0257-11. 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 dermatologicals class.

Drug family (ATC) Other dermatologicals
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 scalp lotion containing pyrithione zinc, an over-the-counter antifungal and antibacterial agent. Pyrithione zinc is commonly used in topical products to help address scalp conditions associated with dandruff and seborrheic dermatitis. The product is applied directly to the scalp and hair as part of a daily refresher routine. This is an OTC monograph drug, meaning it is marketed under FDA's established guidelines for this class of products rather than as an individually reviewed application.

Supplement & herbal interactions

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

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
84126-0257-11 You're viewing this Main listing 118 mL in 1 BOTTLE, PUMP 2026-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sulfur 8 Oil Moisturizer Anti-Dandruff 1 mg/mL 12022-0019-00 J. 237 ml — — FDA listed —
Sulfur 8 Light Moisturizer Anti-Dandruff 1 mg/mL 12022-0020-00 J. 237 ml — — FDA listed —
Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing 1 mg/mL 12022-0029-00 J. 355 ml — — FDA listed —
Head and Shoulders Royal Oils Instant Soothe Scalp .1 g/100mL 69423-0309-12 The 1 bottle — — FDA listed —
Mielle Lavender and Lychee Scalp Soothing Daily Refresher .1 g/100mLthis 84126-0257-11 The 118 ml — — FDA listed —
Dermgentle Seborrheic Scalp Serum 1 mg/g 87261-0101-01 Dermgentle 100 g — — FDA listed —
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum .1 g/100mL 82157-0013-01 The 100 ml — — FDA listed —
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum .1 g/100mL 82157-0015-01 The 100 ml — — FDA listed —
Head and Shoulders Royal Oils Daily Moisture Scalp .1 g/100mL 69423-0307-15 The 150 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 code84126
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio850 products on file

More NDCs from The Procter & Gamble Manufacturing Company labeler code 84126

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 11 words ▾

Uses helps prevent recurrence of flaking and itching associated with dandruff

⏱️ Dosage and Administration 55 words ▾

Directions apply to affected areas one to four times daily or as directed by a doctor. section hair if needed. Remove cap and place nozzle directly onto the scalp pump to cover entire section of exposed scalp (may take 3 or more pumps) Massage into scalp. repeat to cover your entire scalp. Do not rinse.

⚠️ Warnings 65 words ▾

Warnings For external use only When using this product 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 Pyrithione zinc 0.1%

🧪 Inactive Ingredients 45 words ▾

Inactive ingredients Water, niacinamide, PEG-40 hydrogenated castor oil, phenoxyethanol, caffeine, fragrance, bis PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, benzyl alcohol, menthol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin, litchi chinensis fruit extract, mentha arvensis leaf/stem oil, mentha piperita (peppermint) flower/leaf/stem oil, lavandula angustifolia (lavender) flower extract

🎯 Purpose 2 words ▾

Purpose Antidandruff

📄 When Using This Product 16 words ▾

When using this product 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)? 1-800-436-9165

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label Mielle Pyrithione Zinc Dandruff Treatment LAVENDER & LYCHEE SCALP SOOTHING DAILY REFRESHER 4 FL OZ (118 mL) Mielle

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 Mielle Lavender and Lychee Scalp Soothing Daily Refresher (this brand).

Top reported reactions

Death2
Dehydration2
Drug Interaction2
Headache2
Nausea2
Periproctitis2
Pyrexia2

Reporter sex

29 reports
Male · 69%
Female · 31%

Serious outcomes

Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 The Procter & Gamble Manufacturing Company. Listing status can change — the directory data on this page refreshes weekly.
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.
← 84126-0256-35 · The 84126-0258-35 · 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.