Mechanism of actionCorticosteroid Hormone Receptor Agonists
DEA scheduleNon-controlled
Marketing categoryOTC MONOGRAPH DRUG
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2023-05-17
RouteTOPICAL
Dosage formOINTMENT
SubstanceHYDROCORTISONE ACETATE
GPI-1490550075104208
GCN Seq No007526
GCN30851
HICL code002863
Ingredient (HICL)Hydrocortisone Acetate
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ5
Therapeutic class — intermediate (HIC2)Agents Acting Principally On The Skin
HIC3 codeQ5P
Therapeutic class — specific (HIC3)Topical Anti-Inflammatory Steroidal
AHFS code52:08.08.00
AHFS classCorticosteroids (Eent)
FDB label nameHYDROCORTISONE 1% OINTMENT
FDB brand nameHydrocortisone
Legend statusO — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 68001-526-45 — 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 → 68001-0526-45. 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 classCorticosteroid
Drug family (ATC)Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it worksCorticosteroid 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.
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
Label name HYDROCORTISONE 1% OINTMENTIngredient Hydrocortisone Acetate
📖 What it is MedlinePlus · NLM
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
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?
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.
💬 Questions about Antipruritic (Anti-Itch)?
Ask a licensed pharmacist directly — free, answered by our team.
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 T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
UNII 0W8RRI5W5A
A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
UNII B6E5W8RQJ4
White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesMineral Oil, Sorbitan Sesquioleate, White Petrolatum
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 system
Per g
Per package
Retail pharmacies payNADAC · weekly
$0.075
$2.13 / 28.4 g
Medicaid paysCMS SDUD · 12 mo
$0.3359
$9.54 / 28.4 g
Medicare drug plans payPart D · quarterly
No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
▲ Up 5% over the last 11 months.
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.
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
🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68001-0526-45, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.4K
Units reimbursed last 4 qtrs
47.3K
Gross reimbursed last 4 qtrs
$15.9K
Avg / prescription
$11.03
Avg / unit
$0.3359
Latest quarter Q4 2025
240Rx
Medicaid pays / g
$0.3359
gross reimbursed
vs
NADAC / g
$0.0750
acquisition cost
=
Spread
+$0.2609
+348% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
67% FFS33% MCO
Fee-for-service · 970 Rx Managed care · 469 Rx
State Medicaid map
Units reimbursed · per 100k residents
16.599.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1New York99.0 /100k
2Kentucky97.0 /100k
3Michigan40.1 /100k
4California33.0 /100k
5Pennsylvania30.9 /100k
6New Jersey22.6 /100k
7Mississippi16.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Hydrocortisone — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydrocortisone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
📦 Packaging — all sizes for this product
Package NDC
Description
Marketing start
Status
68001-0526-45 You're viewing this
1 TUBE in 1 CARTON (68001-526-45) / 28.4 g in 1 TUBE
2023-05-17
Active
📄 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.
Uses For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.
⏱️Dosage and Administration73 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: consult a doctor. When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching.
⚠️Warnings148 words▾
Warnings For external use only If pregnant or breast-feeding, ask a health professional before use Do not use in the eyes for diaper rash for external genital or feminine itching if you have a vaginal discharge more than the recommended daily dosage unless directed by a doctor this product in the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you are using any other hydrocortisone product 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.
Do not continue to use this or any other hydrocortisone product for longer than 7 days, or if bleeding occurs near anus when used for anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
📦Storage and Handling49 words▾
Other Information Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature Avoid excessive heat Preserve in well-closed container See crimp of tube or carton for Lot Number and Expiry Date
🧪Active Ingredient6 words▾
Active ingredient Hydrocortisone Acetate USP 1%
🧪Inactive Ingredients8 words▾
Inactive Ingredients Mineral Oil, Sorbitan Sesquioleate, White Petrolatum
🎯Purpose3 words▾
Purpose Antipruritic (Anti-Itch)
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
Active ingredient: The part of a medicine that produces its intended effect on the body.
dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.