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Head and Shoulders Royal Oils Instant Soothe Scalp Pyrithione Zinc .1 g/100mL Lotion

by The Procter & Gamble Manufacturing Company · 1 BOTTLE, PUMP in 1 CARTON (69423-309-12) / 125 mL in 1 BOTTLE, PUMP
NDC 69423-0309-12
🏷️ FDA NDC (as labeled) 69423-309-12 billing pads the product segment with a zero
This package
Contains125 mL in 1 bottle, pump Pack sizes2 compare ↓
Also comes in: 50 ml 69423-0309-50
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 69423-309-12
Product NDC 69423-309
11-digit billing NDC 69423030912
RxCUI 1052676, 2104634
UNII R953O2RHZ5
Application # M032
SPL Set ID 7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-30
Route TOPICAL
Dosage form LOTION
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 69423-309-12 — 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 → 69423-0309-12. 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.

🏭 Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedAug 2018
Product typeHuman Otc Drug
Portfolio849 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter lotion applied to the scalp and hair. It contains pyrithione zinc, an ingredient typically used in shampoos and scalp treatments to help manage flaking and itching associated with dandruff and seborrheic dermatitis. Pyrithione zinc functions as an antimicrobial and antifungal agent commonly found in OTC dandruff care products.

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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 55A74AJ3KB
    This is a silicone-based compound that blends polyethylene glycol and polypropylene glycol. It works as an emulsifier and skin-conditioning agent, helping oils and water mix smoothly in topical formulations while improving product texture and spreadability.
  • UNII 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • UNII 71DD5V995L
    A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII Q4R969U9FR
    A chelating agent derived from ethylenediamine, used in formulations to bind metal ions and prevent oxidation, helping preserve the medicine's stability and potency over time.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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, niacinamide, PEG-40 hydrogenated castor oil, menthol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, phenoxyethanol, caffeine, bis-PEG/PPG-16/16 PEG/PPG-16/16 dimethicone, glycerin, fragrance, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, panthenol, tetrahydroxypropyl ethylenediamine, ethylhexylglycerin.

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.

💲 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: 50 ml
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.

🔁 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/100mLthis 69423-0309-12 The 1 bottle — — FDA listed —
Mielle Lavender and Lychee Scalp Soothing Daily Refresher .1 g/100mL 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

🏛️
2018
On the market since
Aug 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.

🔬 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 Pyrithione Zinc — the ingredient across all brands.

Top reported reactions

Pruritus93
Dry Skin58
Rash58
Skin Exfoliation42
Dermatitis Atopic35
Erythema35
Headache32

Age at onset

Infant3
Child31
Adolescent24
Adult140
Elderly61

Reporter sex

582 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization89
Disabling11
Death10
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 60 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69423-0309-12 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (69423-309-12) / 125 mL in 1 BOTTLE, PUMP 2018-08-30 Active
69423-0309-50 50 mL in 1 BOTTLE, PUMP (69423-309-50) 2019-11-21 Discontinued by firm

Pack size FAQ

What quantity is in NDC 69423-0309-12?
NDC 69423-0309-12 is listed by the FDA — 1 bottle, pump in 1 carton / 125 ml in 1 bottle, pump.
What NDC number is used to bill for this package of Head and Shoulders Royal Oils Instant Soothe Scalp Pyrithione Zinc .1 g/100mL Lotion?
Bill NDC 69423-0309-12 — the 11-digit billing format is 69423030912. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 69423-309-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69423-0309-12, written without dashes as 69423030912. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69423-0309-12, the first segment (69423) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0309) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 ml (69423-0309-50). 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.

📄 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
🎯 Indications and Usage 11 words ▾

Uses helps prevent recurrence of flaking and itching associated with dandruff.

⏱️ Dosage and Administration 58 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 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 34 words ▾

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

🎯 Purpose 2 words ▾

Purpose Anti-dandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69423-0307-15 · The 69423-0311-37 · 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.