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American Red Cross Anti-Itch Hydrocortisone 1.0%(w/w) 1 g/100g Spray, 141 g — NDC 51628-4527-01 package photo

American Red Cross Anti-Itch Hydrocortisone 1.0%(w/w) 1 g/100g Spray, 141 g

by MY IMPORTS USA LLC · 141 g in 1 BOTTLE, SPRAY (51628-4527-1)
NDC 51628-4527-01
🏷️ FDA NDC (as labeled) 51628-4527-1 billing pads the package 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) 51628-4527-1
Product NDC 51628-4527
11-digit billing NDC 51628452701
RxCUI 317564
UNII WI4X0X7BPJ
Application # M016
SPL Set ID 421da126-a1c4-54d7-e063-6394a90ac401
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 2025-10-27
Route TOPICAL
Dosage form SPRAY
Substance HYDROCORTISONE
Why two NDCs? The FDA registers this code as 51628-4527-1 — 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 → 51628-4527-01. 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.

🏭 Manufacturer & labeler

LabelerMY IMPORTS USA LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code51628
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio107 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

📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anti Itch 1 g/100g 00363-9801-01 Walgreens 1 can — — FDA listed —
Rite Aid Cortisone 1 g/100g 11822-0113-03 Rite 85 g — — FDA listed —
Cooling Itch Relief 1 g/100g 13709-0310-01 NeilMed 85 g — — FDA listed —
Anti Itch 1 g/100g 13709-0327-01 Neilmed 1 can — — FDA listed —
Kroger Anti Itch 1 g/100g 30142-0270-03 The 85 g — — FDA listed —
Cortizone 10 Fast Acting Itch Relief Cooling 1 g/100g 41167-0343-00 Chattem, 76 g — — FDA listed —
Instant Cooling Itch Relief 10 mg/g 51316-0388-03 CVS 85 g — — FDA listed —
American Red Cross Anti-Itch 1 g/100gthis 51628-4527-01 MY 141 g — — FDA listed —
Hydrocortisone 1.13 g/113g 56104-0250-00 Premier 113 g — — FDA listed —
DCH Labs Cortisone 1 g/100g 72839-0113-03 Derma 85 g — — FDA listed —
American Red Cross Anti-Itch 1 g/100g 75742-0070-01 Zhejiang 141 g — — FDA listed —
Pediadermics Eczema 2 1.12 g/112g 76348-0585-04 RENU 112 g — — FDA listed —
Hydrocortisone 10 mg/mL 79481-9967-01 Meijer 74 ml — — FDA listed —
Equate Cortisone 1 g/100g 79903-0213-03 Walmart 85 g — — FDA listed —
Hydrocortisone 10 mg/mL 81522-0914-01 FSA 74 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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
51628-4527-01 You're viewing this 141 g in 1 BOTTLE, SPRAY (51628-4527-1) 2025-10-27 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 51628-4527-1, 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: 51628-4527-01, written without dashes as 51628452701. 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 51628-4527-01, the first segment (51628) is the labeler code FDA assigned to MY IMPORTS USA LLC; the middle segment (4527) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 MY IMPORTS USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
MY IMPORTS USA 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 43 words ▾

Uses for the temporary relief of itching associated with minor skin irritation and rashes due to eczema,poison ivy, oak and sumac, cosmetics, soaps and detergents, jewelry, insect bites. Other uses of this product should be only under advice and supervision of a doctor.

⏱️ Dosage and Administration 41 words ▾

Directions adults and children 2 years or older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: aks a doctor to apply to face, spray into palm of hand and gently apply.

⚠️ Warnings 132 words ▾

Warnings For external use only. Flammable, keep away from heat, spark, electrical, fire or flame. Do note use Do nost use for the treatment of diaper rash.

Consult a doctor. When using this product avoid contact with eyes avoid contact with broken skin do not inhale or ingest. Use only as directed.

Interntional misuse by deliberatebly concentrating and inhaling contents can be harmful or fatal. contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ºF.

Stop use and ask a doctor if Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again with a few days. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 17 words ▾

Other information store cap tightly closed and at controlled room temperature harmful to wood finishes and plastics

🧪 Active Ingredient 4 words ▾

Active ingredient Hydrocortisone 1.0%(w/w)

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients Water(Aqua) Ethyl alcohol Butane Propane Glycerin Polyvinylpyrrolidone Menthol

🎯 Purpose 2 words ▾

Purpose Anti-itch

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51628-4526-01 · MY 51628-4528-01 · MY →
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.