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Pete and Pedro Control Anti Itch Dandruff COAL TAR 62.5 mg/mL Shampoo, 236 mL — NDC 84503-0508-00 package photo

Pete and Pedro Control Anti Itch Dandruff COAL TAR 62.5 mg/mL Shampoo, 236 mL

by PETE AND PEDRO LLC · 236 mL in 1 BOTTLE (84503-508-00)
NDC 84503-0508-00
🏷️ FDA NDC (as labeled) 84503-508-00 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) 84503-508-00
Product NDC 84503-508
11-digit billing NDC 84503050800
RxCUI 309381
UNII R533ESO2EC
Application # M032
SPL Set ID 34ec83c1-31b9-4ecc-8bd2-898fd85364ba
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-25
Route TOPICAL
Dosage form SHAMPOO
Substance COAL TAR
Why two NDCs? The FDA registers this code as 84503-508-00 — 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 → 84503-0508-00. 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

LabelerPETE AND PEDRO LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code84503
First marketedJun 2024
Product typeHuman Otc Drug
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

📗 Our plain-language guide HelloPharmacist
  • Coal tar is used to relieve and help prevent symptoms like itching, flaking, scaling, redness, and skin irritation caused by psoriasis, seborrheic dermatitis, and dandruff. Dependi...
  • Wet your hair first, then work the shampoo into your scalp and massage it in well. Leave the lather sitting on your scalp for several minutes before rinsing — that contact time is...
  • How do I use a coal tar shampoo correctly?
  • It can. Coal tar ointments and lotions in particular may stain clothing or bedding, so blotting off any excess and using old linens while you're being treated is a smart move. Some...
📖 Read our full Coal Tar 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.

🧪 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 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 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 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 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 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 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII B16G315W7A
    A plant-derived thickener made from guar gum that has been chemically modified to carry a positive charge. It's used in medicines as a thickening agent and to help keep ingredients evenly mixed throughout the product.
  • 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 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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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 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 statesAqua (Deionized Water), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Glycerin, SD-Alcohol 408, Menthol, Sodium Chloride, Cocamide MEA, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Caprylyl Glycol, Glycol stearate, Guar Hydroxypropyltrimonium Chloride, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Citrus Aurantium (Bergamot) Oil, FD&C 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
Thera-Gel 5 mg/mL 00904-5259-44 Major 251 ml $0.009 — Availability likely —
DHS tar gel .005 g/g 00096-0736-08 Person 249.6 g $0.043 — Availability likely —
Dhs Tar .005 g/g 00096-0737-04 Person 125.04 g — — FDA listed —
DHS Tar 5 mg/mL 00096-0813-08 Person 240 ml — — FDA listed —
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 00363-1591-01 Walgreen 1 bottle — — FDA listed —
Meijer T Plus Gel Coal Tar Anti-Dandruff 5 mg/mL 41250-0249-01 Meijer 251 ml — — FDA listed —
Medicasp Anti-Dandruff 5 mg/mL 50066-0040-06 Genomma 1 bottle — — FDA listed —
therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 50804-0887-01 GOODSENSE 473 ml — — FDA listed —
Family Wellness Therapeutic Tplus PLUS Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 55319-0485-01 FAMILY 251 ml — — FDA listed —
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 67385-0702-01 Garcoa, 1 bottle — — FDA listed —
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 72288-0043-01 AMAZON.COM 473 ml — — FDA listed —
QC Anti Dandruff T Plus 5 mg/mL 75376-0286-08 Guangzhou 236 ml — — FDA listed —
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 76162-0190-01 Topco 251 ml — — FDA listed —
meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 79481-0083-01 Meijer 473 ml — — FDA listed —
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 79903-0087-01 Wal-Mart 1 bottle — — FDA listed —
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 5 mg/mL 79903-0291-01 Wal-Mart 1 bottle — — FDA listed —
QC Anti Dandruff T Plus 5 mg/mL 83324-0286-08 Chain 236 ml — — FDA listed —
Pete and Pedro Control Anti Itch Dandruff 62.5 mg/mLthis 84503-0508-00 PETE 236 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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 Pete and Pedro Control Anti Itch Dandruff (this brand).

Top reported reactions

Psoriasis420
Malaise300
Fatigue267
Pain252
Nasopharyngitis236
Skin Exfoliation227
Fall223

Age at onset

Child1
Adult62
Elderly66

Reporter sex

757 reports
Male · 36%
Female · 64%

Serious outcomes

Hospitalization351
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 113 35
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
84503-0508-00 You're viewing this 236 mL in 1 BOTTLE (84503-508-00) 2024-06-25 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 84503-508-00, 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: 84503-0508-00, written without dashes as 84503050800. 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 84503-0508-00, the first segment (84503) is the labeler code FDA assigned to PETE AND PEDRO LLC; the middle segment (0508) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PETE AND PEDRO LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PETE AND PEDRO LLC 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 8 words ▾

Uses For relief of the symptoms of dandruff

⏱️ Dosage and Administration 16 words ▾

Directions: Apply to affected areas one to four times daily or as directed by a doctor.

⚠️ Warnings 121 words ▾

Warnings: For external use only. Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for upto 24 hours after application.

Do not use for prolonged periods without consulting doctor. Do not use before consulting your doctor, if condition covers a large area of the body. When using this product Avoid contact with the 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 a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 11 words ▾

Active Ingredients Coal Tar Solution 6.25% (Coal Tar 0.50%) Purpose Anti-dandruff

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients: Aqua (Deionized Water), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Glycerin, SD-Alcohol 408, Menthol, Sodium Chloride, Cocamide MEA, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Caprylyl Glycol, Glycol stearate, Guar Hydroxypropyltrimonium Chloride, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Citrus Aurantium (Bergamot) Oil, FD&C 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 ↗
← 84502-0115-02 · Fujian 84505-0001-01 · Hebei →
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.