HomeNDC LookupIngredientsSalicylic Acid › 61995-1606-08
Avalon Organics Antidandruff Salicylic Acid 2 g/414g Shampoo, 414 g — NDC 61995-1606-08 package photo

Avalon Organics Antidandruff Salicylic Acid 2 g/414g Shampoo, 414 g

by The Hain Celestial Group, Inc. · 414 g in 1 BOTTLE (61995-1606-8)
NDC 61995-1606-08
🏷️ FDA NDC (as labeled) 61995-1606-8 billing pads the package segment with a zero
This package
Contains414 g Pack sizes2 compare ↓
Also comes in: 325 g 61995-1606-09
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 →

🆔 Identity & classification

FDA NDC (as labeled) 61995-1606-8
Product NDC 61995-1606
11-digit billing NDC 61995160608
UNII O414PZ4LPZ
Application # M016
SPL Set ID 66c7f730-64f3-4eef-e053-2a91aa0a4225
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-07-28
Route TOPICAL
Dosage form SHAMPOO
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 61995-1606-8 — a 5-4-1 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 package segment → 61995-1606-08. 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.

🏭 Manufacturer & labeler

LabelerThe Hain Celestial Group, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code61995
First marketedJul 2016
Product typeHuman Otc Drug
Portfolio12 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 shampoo containing salicylic acid, a keratolytic agent typically used to help reduce flaking and itching associated with dandruff and seborrheic dermatitis of the scalp. Salicylic acid works by helping to soften and shed buildup on the skin surface. The product is formulated under FDA's over-the-counter monograph rules for antidandruff shampoos and is applied topically by washing into the hair and scalp.

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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 ZX5QRE4U60
    A fragrant plant oil derived from cedar bark, used as a natural flavoring and aroma agent in medicines. It helps mask unpleasant tastes and adds pleasant scent to the product.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII OO4K72NZ2X
    A plant-derived powder from quinoa seeds, used as a filler and binding agent to give the tablet or capsule structure and help hold its ingredients together during manufacturing and storage.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 1VH544O5AT
    A natural resin derived from the copaiba tree, used as a binder and film-former in medications. It helps hold tablet ingredients together and can create protective coatings on solid dosage forms.
  • UNII 7626GC95E5
    A natural aromatic oil extracted from coriander seeds. Used as a flavoring agent to mask bitter tastes and improve the overall taste of medicines, making them easier to take.
  • UNII MBK0CP8F5A
    Disodium cocoyl glutamate is a mild cleanser derived from coconut oil and amino acids. It acts as a surfactant and emulsifier in medicines, helping to mix oil and water-based ingredients together and improve how the product spreads or absorbs.
  • UNII H2E371EDYX
    A fragrant essential oil from geranium plant roots used as a natural flavoring agent and aromatic ingredient to improve the taste and smell of the medicine.
  • UNII 4PC054V79P
    A fatty acid derived from glycerin and oleic acid (a natural oil component). It acts as an emulsifier to help mix oil and water-based ingredients, and serves as a lubricant and surfactant in the formulation.
  • UNII ZBX50UG81V
    A salt derived from phytic acid, a natural compound found in plants. In medications, it functions as a chelating agent and buffering substance, helping to stabilize formulations and control pH levels.
  • UNII JOS53KRJ01
    Inulin is a fiber derived from plants like chicory root. It acts as a filler and binder in medicines to add bulk and help hold tablets together.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII 9MC3I34447
    A natural oil extracted from citrus peel, used as a flavoring agent and solvent to improve taste and help dissolve or distribute other ingredients in the medicine.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII G43C57162K
    A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
  • 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 79M2M2UDA9
    Mentha piperita is peppermint, a plant extract used in medicines as a flavoring agent and to provide a cooling or soothing taste. It helps make the medication more pleasant to take.
  • 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 AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII H6UKY25H2P
    A plant extract from patchouli leaves used as a fragrance and flavoring agent in medicines to improve taste and scent.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII NR1A27F29O
    A plant extract from rosemary flowers used as a natural preservative and antioxidant. It helps prevent oils and fats in the medicine from spoiling, keeping the product fresh 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 3599J29ANH
    A cleansing agent derived from coconut oil. It helps break down and mix oil and water in the formulation, and may aid in dispersing the active ingredient throughout the product.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII FE663Z8IRO
    A resinous gum extracted from the styrax tree, used as a preservative and binder in medicines. It helps prevent spoilage and holds ingredients together in solid formulations.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Juice (1), Sodium Coco-Sulfate, Coco-Glucoside, Sodium Laurylglucosides Hydroxypropylsulfonate, Glyceryl Oleate, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Mentha Arvensis Leaf Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract (1), Chenopodium Quinoa Seed (1), Rosmarinus Officinalis (Rosemary) Leaf Extract (1), Styrax Benzoin Resin Extract, Tocopheryl Acetate, Bisabolol, Citric Acid, Disodium Cocoyl Glutamate, Inulin (1), Menthol, Potassium Hydroxide, Sodium Chloride, Sodium Phytate, Sodium Sulfate, Water (Aqua), Alcohol, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool. (1) Certified Organic Ingredient

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 DailyMedingredient 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: 325 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Avalon Organics Antidandruff 2 g/414gthis 61995-1606-08 The 414 g 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
Jul 2016
📍
2026
Currently FDA-listed
10 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.

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

Medicare Part D (outpatient prescription) spending for Salicylic Acid (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 Salicylic Acid. 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
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
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 Avalon Organics Antidandruff (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization623
Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 252 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
61995-1606-08 You're viewing this 414 g in 1 BOTTLE (61995-1606-8) 2016-07-28 Active
61995-1606-09 325 g in 1 BOTTLE (61995-1606-9) 2025-07-02 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61995-1606-08?
NDC 61995-1606-08 contains 414 g — 414 g in 1 bottle.
What is the difference between NDC 61995-1606-08 and NDC 61995-1606-09?
Both are Avalon Organics Antidandruff Salicylic Acid 2 g/414g Shampoo — the drug itself is identical. NDC 61995-1606-08 is the 414 g package, while NDC 61995-1606-09 is the 325 g package.
What NDC number is used to bill for this package of Avalon Organics Antidandruff Salicylic Acid 2 g/414g Shampoo?
Bill NDC 61995-1606-08 — the 11-digit billing format is 61995160608. 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 ✓ 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 FDA registers it as 61995-1606-8, 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: 61995-1606-08, written without dashes as 61995160608. 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 61995-1606-08, the first segment (61995) is the labeler code FDA assigned to The Hain Celestial Group, Inc.; the middle segment (1606) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Hain Celestial Group, Inc.. 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 325 g (61995-1606-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
The Hain Celestial Group, Inc. 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 14 words

For relief of flaking, scaling and itching associated with dandruff. Helps prevent seborrheic dermatitis

⏱️ Dosage and Administration 22 words

For the best results use at least three times each week. Wet hair, lather, massage onto scalp. Rinse and repeat if desired.

⚠️ Warnings 27 words

For external use only. Avoid contact with eyes. Rinse eyes throughly with water in case contact ossurs. Discontinue to use and contact your physician if irritation develops.

🧪 Active Ingredient 3 words

Salicylic Acid 2.0%

🧪 Inactive Ingredients 122 words

Aloe Barbadensis Leaf Juice (1), Sodium Coco-Sulfate, Coco-Glucoside, Sodium Laurylglucosides Hydroxypropylsulfonate, Glyceryl Oleate, Cedrus Atlantica Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil (1), Mentha Arvensis Leaf Oil, Mentha Piperita (Peppermint) Oil, Pogostemon Cablin Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract (1), Chenopodium Quinoa Seed (1), Rosmarinus Officinalis (Rosemary) Leaf Extract (1), Styrax Benzoin Resin Extract, Tocopheryl Acetate, Bisabolol, Citric Acid, Disodium Cocoyl Glutamate, Inulin (1), Menthol, Potassium Hydroxide, Sodium Chloride, Sodium Phytate, Sodium Sulfate, Water (Aqua), Alcohol, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool.

(1) Certified Organic Ingredient

🎯 Purpose 8 words

Controls symptoms of dandruff, seboric dermatitis and psoriasis

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