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Divine Dandrene 2% Zinc Pyrithione 2 g/100mL Shampoo, 205 mL — NDC 69188-0200-07 package photo

Divine Dandrene 2% Zinc Pyrithione 2 g/100mL Shampoo, 205 mL

by DS Healthcare Group, Inc. · 205 mL in 1 BOTTLE, PLASTIC (69188-200-07)
NDC 69188-0200-07
🏷️ FDA NDC (as labeled) 69188-200-07 billing pads the product segment with a zero
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) 69188-200-07
Product NDC 69188-200
11-digit billing NDC 69188020007
RxCUI 244458, 2059178
UNII R953O2RHZ5
Application # M032
SPL Set ID 54b0a610-dd15-4064-9feb-4d30b5e522ad
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-01
Route TOPICAL
Dosage form SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 69188-200-07 — 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 → 69188-0200-07. 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

LabelerDS Healthcare Group, Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code69188
First marketedJun 2021
Product typeHuman Otc Drug
Portfolio3 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?

Divine Dandrene is a topical shampoo containing 2% zinc pyrithione, an OTC monograph product. Zinc pyrithione is commonly used in shampoos to help reduce flaking and itching associated with dandruff and seborrheic dermatitis of the scalp. This ingredient functions by slowing the growth of yeast and bacteria on the skin. The product is applied to the scalp and hair during shampooing.

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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII D6DH1DTN7E
    Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 0WT12SX38S
    Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
  • UNII 023XA5Z50L
    Hexamidine diisethionate is a synthetic antimicrobial compound used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and stability during storage.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII 6F36Q0I0AC
    PEG-150 distearate is a waxy substance made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help blend water and oil-based ingredients, and may also function as a thickener or lubricant in the formulation.
  • 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 D9B634V4GP
    A plant extract from pomegranate flowers used as a natural colorant, flavoring agent, or antioxidant in medicines. It helps preserve product stability and may contribute to the medicine's taste or appearance.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 29MS2WI2NU
    Shikimic acid is a naturally occurring organic compound found in some plants. In medicines, it may serve as a buffer or pH adjuster to help maintain the stability and proper acidity level of the formulation.
  • 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 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII D0Y70F2B9J
    A synthetic detergent and surfactant derived from fatty acids. It reduces surface tension in formulations to help with mixing, emulsifying, and creating foams or dispersions in topical products.
  • UNII AIQ58N56TM
    Surinamine is a synthetic chemical compound used in medicines as a buffer and pH regulator. It helps maintain the proper acidity level in the formulation to ensure stability and consistent drug performance.
  • UNII S0FAJ1R9CD
    A sulfur-containing compound used in pharmaceutical formulations as an antimicrobial preservative and antioxidant. It helps prevent bacterial and fungal contamination in medicines while protecting other ingredients from degradation.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesWater, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

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.
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
Dhs Zinc 20 mg/mL 00096-0735-08 Person 240 ml — — Discontinued —
Dhs Zinc 20 mg/mL 00096-0811-08 Person 240 ml — — FDA listed —
DermaZinc 2 g/100mL 35324-0003-08 WynnPharm 240 ml — — FDA listed —
DermaZinc 2 g/100g 35324-0004-04 WynnPharm 120 g — — FDA listed —
Vanicream 2 g/100mL 45334-0206-07 Pharmaceutical 7.4 ml — — FDA listed —
Zolidyne 20 mg/mL 51326-0203-67 Topiderm, 200 ml — — FDA listed —
Flakes Cedar Mint Anti Dandruff .02 kg/kg 52261-1400-01 Cosco 266 kg — — FDA listed —
Denorex Severe Flakes Medicated Anti Dandruff .02 g/mL 62673-0176-10 Neoteric 1 bottle — — FDA listed —
Divine Dandrene 2% 2 g/100mLthis 69188-0200-07 DS 205 ml — — FDA listed —
Dermaharmony Pyrithione Zinc with Shea Butter 2 g/100g 71819-0017-37 D3 105 g — — FDA listed —
Dermaharmony Tea Tree Bar 2 g/100g 71819-0018-04 D3 113 g — — FDA listed —
Dermaharmony Unscented Bar 2 g/100g 71819-0019-04 D3 113 g — — FDA listed —
Dzul Anti-Dandruff Conditioner 2 g/100mL 83037-0002-08 Caball 236 ml — — FDA listed —
Dandrx Anti-Dandruff 2 g/100mL 85521-0002-08 dandRX 237 ml — — FDA listed —
Happy Head Anti-Dandruff 20 mg/mL 87117-0970-00 Happy 177 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69188-0200-07 You're viewing this 205 mL in 1 BOTTLE, PLASTIC (69188-200-07) 2021-06-01 Active

🧭 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 69188-200-07, 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: 69188-0200-07, written without dashes as 69188020007. 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 69188-0200-07, the first segment (69188) is the labeler code FDA assigned to DS Healthcare Group, Inc.; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 DS Healthcare Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DS Healthcare 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

Uses Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff

⏱️ Dosage and Administration 45 words ▾

Directions Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 minutes, rinse For best results use atleast 2 times per week or as direacted by a doctor For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

⚠️ Warnings 63 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 out of reach of children . If swallowed, get medical help or contact Poison Control Center right away

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Pyrithione 2%

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

🎯 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 ↗
← 69188-0100-07 · DS 69188-0300-07 · DS →
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.