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Medicated Body Menthol and Zinc Oxide 1.5 mg/g; 10 mg/g Powder, 226 g — NDC 52000-0038-26 package photo

Medicated Body Menthol and Zinc Oxide 1.5 mg/g; 10 mg/g Powder, 226 g

by Universal Distribution Center LLC · 226 g in 1 BOTTLE (52000-038-26)
NDC 52000-0038-26
🏷️ FDA NDC (as labeled) 52000-038-26 billing pads the product segment with a zero
This package
Contains226 g Pack sizes2 compare ↓
Also comes in: 283 g 52000-0038-25
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

⚠️
Other active recalls for Menthol And Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0213-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 52000-038-26
Product NDC 52000-038
11-digit billing NDC 52000003826
RxCUI 577232
UNII L7T10EIP3A, SOI2LOH54Z
UPC 0676979555645
Application # M016
SPL Set ID 2a59a847-cc7a-42cf-b49a-92e7254c1629
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-04
Route TOPICAL
Dosage form POWDER
Substance MENTHOL, UNSPECIFIED FORM; ZINC OXIDE
Why two NDCs? The FDA registers this code as 52000-038-26 — 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 → 52000-0038-26. 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

LabelerUniversal Distribution Center LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code52000
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio92 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 topical powder containing menthol and zinc oxide. Menthol is typically used in skin products to create a cooling sensation, while zinc oxide is commonly used as a protective barrier ingredient and mild astringent. Together, these ingredients are found in products intended for localized skin care and comfort. This product is marketed under the FDA's monograph rules for over-the-counter drugs in its category.

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 RV6J6604TK
    Eucalyptol is a natural oil compound extracted from eucalyptus plants. In medicines, it serves as a flavoring agent and aromatic component to improve taste and smell.
  • UNII H18F76G097
    Acacia seyal gum is a natural plant gum extracted from acacia trees. It acts as a binder and thickener in medicines to hold ingredients together and give the product proper texture and consistency.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 3J50XA376E
    Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.
  • UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.
  • UNII H92E6QA4FV
    Zinc stearate is a fine white powder made from zinc and stearic acid. It works as a lubricant and glidant to help the tablet or capsule move smoothly through manufacturing equipment and prevents sticking.

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

The official label also statesZea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

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: 283 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
Studio 35 External Analgesic Medicated Body 1.5 mg/g; 10 mg/g 00363-0552-38 Walgreen 283 g — — FDA listed —
Medicated Body 1.5 mg/g; 10 mg/gthis 52000-0038-26 Universal 226 g — — FDA listed —
MedPride Medicated Body Powder Powder .15 g/100g; 1 g/100g 52410-4031-00 Shield 283 g — — FDA listed —
Health Smart Medicated Body .15 g/100g; 1 g/100g 52862-0030-01 International 283 g — — FDA listed —
Amerfresh Medicated Body Powder .15 g/100g; 1 g/100g 87510-0001-01 ONEST 285 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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 Medicated BODY (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

990 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization334
Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 96 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
52000-0038-25 283 g in 1 BOTTLE (52000-038-25) 2017-12-04 Active
52000-0038-26 You're viewing this 226 g in 1 BOTTLE (52000-038-26) 2017-12-04 Active

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

Pack size FAQ

What quantity is in NDC 52000-0038-26?
NDC 52000-0038-26 contains 226 g — 226 g in 1 bottle.
What is the difference between NDC 52000-0038-26 and NDC 52000-0038-25?
Both are Medicated Body Menthol and Zinc Oxide 1.5 mg/g; 10 mg/g Powder — the drug itself is identical. NDC 52000-0038-26 is the 226 g package, while NDC 52000-0038-25 is the 283 g package.
What NDC number is used to bill for this package of Medicated Body Menthol and Zinc Oxide 1.5 mg/g; 10 mg/g Powder?
Bill NDC 52000-0038-26 — the 11-digit billing format is 52000003826. 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 52000-038-26, 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: 52000-0038-26, written without dashes as 52000003826. 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 52000-0038-26, the first segment (52000) is the labeler code FDA assigned to Universal Distribution Center LLC; the middle segment (0038) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (26) 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 Universal Distribution Center LLC. 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 283 g (52000-0038-25). 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?
Universal Distribution Center 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 47 words ▾

Uses for the temporary relief of pain and itching associated with • Backache • Minor Burn • Minor Skin Irritations • Minor Cut • Sunburn • Insect Bites • Ooozing and weeping of poison ivy, poison oak and poison sumac can be dried using Universal Medicated Powder

⏱️ Dosage and Administration 39 words ▾

Directions Adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily Children under 2 years of age: consult a doctor For best results, dry area thoroughly before applying

⚠️ Warnings 61 words ▾

WARNING for external use only. When using this product avoid contact with the eyes. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

🧪 Active Ingredient 7 words ▾

Active Ingredient Menthol 0.15% Zinc Oxide 1.0%

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients Zea mays (corn) starch, sodium bicarbonate, tricalcium phosphate, acacia seyal gum, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate

🎯 Purpose 5 words ▾

Purpose External analgesic Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52000-0022-37 · Universal 52000-0040-41 · Universal →
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.