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Marie Originals Medicated Outdoor Anti Itch Hydrocortisone Spray 10 mg/mL Spray, 177 mL — NDC 87541-0321-86 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Marie Originals Medicated Outdoor Anti Itch Hydrocortisone Spray 10 mg/mL Spray, 177 mL — NDC 87541-321-86 (Billing 87541-0321-86)

by Marie's Original Formulas LLC · 177 mL in 1 BOTTLE, SPRAY

This is a package of 177 mL of Marie Originals Medicated Outdoor Anti Itch Hydrocortisone Spray 10 mg/mL Spray from Marie's Original Formulas LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 87541-0321-86
🏷️ FDA NDC (as labeled) 87541-321-86 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 87541-321-86 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87541 labeler · 321 product · 86 package
Package marketed since
Jul 10, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850073386552
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87541-321-86
Product NDC 87541-321
11-digit billing NDC 87541032186
RxCUI 317564
UNII WI4X0X7BPJ
UPC 0850073386552
Application # M017
SPL Set ID 55188ede-68cd-fcc6-e063-6394a90a5c58
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-10
Route TOPICAL
Dosage form SPRAY
Substance HYDROCORTISONE
Quick answers
  • RxCUI (RxNorm): 317564
Why two NDCs? The FDA registers this code as 87541-321-86 — 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 → 87541-0321-86. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor Agonists
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone 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.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87541-0321-86 You're viewing this Main listing 177 mL in 1 BOTTLE, SPRAY 2026-07-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 10 mg/mL 81522-0914-01 FSA 74 ml — — FDA listed —
Hydrocortisone 10 mg/mL 79481-9967-01 Meijer 74 ml — — FDA listed —
Marie Originals Medicated Outdoor Anti Itch 10 mg/mLthis 87541-0321-86 Marie's 177 ml — — FDA listed —
Marie Originals Medicated Outdoor Anti Itch 10 mg/mL 87541-0031-63 Marie's 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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.

🧪 Avoiding an ingredient? See Hydrocortisone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 8FP93ED6H2
    Witch hazel is a plant extract made from the leaves and twigs of the witch hazel shrub. In medicines, it works as a soothing and astringent ingredient that helps reduce inflammation and tighten skin.
  • UNII G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • 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 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals 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.

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

The official label also statesWater (Aqua), Alcohol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 20, Calendula Officinalis Flower Extract, Panthenol, Saccharide Isomerate, Hamamelis Virginiana (Witch Hazel) Water, Bisabolol, Sodium Phytate.

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.

Manufacturer & labeler

LabelerMarie's Original Formulas LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code87541
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Marie's Original Formulas LLC labeler code 87541

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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and seborrheic dermatitis.

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only.

📦 Storage and Handling 21 words ▾

Other information Store at 20° to 25°C (68° to 77°F). Protect from excessive heat and direct sunlight. Keep container tightly closed.

🧪 Active Ingredient 3 words ▾

Hydrocortisone 1% Back

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Water (Aqua), Alcohol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 20, Calendula Officinalis Flower Extract, Panthenol, Saccharide Isomerate, Hamamelis Virginiana (Witch Hazel) Water, Bisabolol, Sodium Phytate.

🎯 Purpose 2 words ▾

Purpose Anti-itch

📄 Do Not Use 27 words ▾

Do not use for the treatment of diaper rash. Consult a doctor. if you have a skin infection in the affected area unless directed by a doctor.

📄 Ask a Doctor Before Use If 24 words ▾

Ask a doctor before use if condition covers a large area of the body symptoms persist or worsen you have signs of skin infection

📄 When Using This Product 26 words ▾

When using this product avoid contact with eyes do not use more than directed do not bandage or cover treated skin unless directed by a doctor

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days symptoms clear up and occur again within a few days redness, irritation, or infection develops

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-888-48-MARIE

📄 Package Label / Principal Display Panel 48 words ▾

Principal Display Panel Marie Originals Medicated Outdoor ANTI-ITCH SPRAY HYDROCORTISONE 1% Poison Ivy/Oak Relief Skin Rash Relief Insect Bite Relief Fast-Acting Relief for Skin Irritation • Temporarily Relieves Itching • Fast-Drying, Easy-to-Apply Spray • Soothes Redness, Sensitivity & Skin Discomfort NET CONTENTS 6 FL OZ (177 mL) Front

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Marie's Original Formulas LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Marie's Original Formulas 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.
← 87541-0031-63 · Marie's 87541-0370-92 · Marie's →
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.