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Hydrocortisone 1 g/100g Ointment, 28 g — NDC 11383-0268-01 package photo

Hydrocortisone 1 g/100g Ointment, 28 g

by Weeks & Leo Co., Inc. · 28 g in 1 TUBE (11383-268-01)
NDC 11383-0268-01
🏷️ FDA NDC (as labeled) 11383-268-01 billing pads the product segment with a zero
This package
Contains28 g Pack sizes2 compare ↓
Also priced by: Part D plans $0.1730/unit — full pricing hub ↓
Also comes in: 59 g 11383-0268-02
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) 11383-268-01
Product NDC 11383-268
11-digit billing NDC 11383026801
RxCUI 203105
UNII WI4X0X7BPJ
Application # M017
SPL Set ID 0c5325e3-4796-856c-e063-6394a90a1f90
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 2023-10-01
Route TOPICAL
Dosage form OINTMENT
Substance HYDROCORTISONE
Why two NDCs? The FDA registers this code as 11383-268-01 — 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 → 11383-0268-01. 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

LabelerWeeks & Leo Co., Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11383
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio10 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 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.

Read the full MedlinePlus article ↗
📗 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 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 · Q2 2026 $0.1730 $4.84 / 28 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
hydrocortisone 1 g/100g 45802-0276-03 Padagis 1 tube $0.070 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone 1 g/100g 24385-0276-03 AmerisourceBergen 1 tube $0.077 — Availability likely —
sunmark Hydrocortisone 1 g/100g 49348-0522-72 Strategic 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 51672-2018-02 Sun 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 70677-1214-01 STRATEGIC 1 tube $0.077 — Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.138 AT Availability likely —
Good Sense Anti Itch 1 g/100g 00113-0471-64 L. 1 tube — — FDA listed —
Maximum Strength Hydrocortisone 1 g/100g 00363-0230-03 Walgreens 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 00363-1333-01 Walgreens 1 tube — — FDA listed —
Aquaphor Itch Relief 1 g/100g 10356-0120-04 Beiersdorf 28 g — — FDA listed —
Hydrocortisone 1 g/100gthis 11383-0268-01 Weeks 28 g — — FDA listed —
Rite Aid Hydrocortisone 1 g/100g 11822-2685-01 Rite 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 21922-0098-04 Encube 1 tube — — FDA listed —
Maximum Strength Hydrocortisone 1 g/100g 24286-1560-01 DLC 1 tube — — FDA listed —
TopCare Hydrocortisone 1 g/100g 36800-0018-02 Topco 1 tube — — FDA listed —
Topcare Hydrocortisone 1 g/100g 36800-0471-64 Topco 1 tube — — FDA listed —
Shopko Hydrocortisone 1 g/100g 37012-0018-02 Shopko 1 tube — — FDA listed —
hydrocortisone 1 g/100g 37808-0471-64 H 1 tube — — FDA listed —
equaline anti itch 1 g/100g 41163-0471-64 United 1 tube — — FDA listed —
Cortizone 10 Water Resistant 1 g/100g 41167-0344-00 Chattem, 1 tube — — FDA listed —
hydrocortisone 1 g/100g 50090-6526-00 A-S 1 tube — — FDA listed —
CVS Health Maximum Strength Hydrocortisone 10 mg/g 51316-0165-28 CVS 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 63187-0543-01 Proficient 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 69396-0003-20 TRIFECTA 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 69396-0017-05 Trifecta 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 69396-0149-01 TRIFECTA 1 tube — — FDA listed —
Maximum Strength Cortisone 1 g/100g 69842-0259-03 CVS 1 tube — — FDA listed —
Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 ViaDerma 1 bottle — — FDA listed —
hydrocortisone 1 g/100g 72162-2284-02 Bryant 1 tube — — FDA listed —
FixMySkin Healing Balm Fragrance-Free 10 mg/mL 76314-0002-03 Lovely 14.78 ml — — FDA listed —
FixMySkin Healing Balm Unflavored 10 mg/mL 76314-0003-01 Lovely 4.43 ml — — FDA listed —
FixMySkin Healing Balm Vanilla Flavor 10 mg/mL 76314-0004-01 Lovely 4.43 ml — — FDA listed —
anti itch 1 g/100g 79481-0471-00 Meijer, 1 tube — — FDA listed —
MediBalm 1 g/100g 85529-0204-01 BalmRx, 1 jar — — FDA listed —
Quitch Anit-Ich Healing Body Balm .07 g/7g 87560-0141-92 Mor 1 cartridge — — FDA listed —
Family Wellness 1 g/100g 69571-0009-01 FRONT 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 68016-0529-01 Pharmacy 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 68016-0149-01 Pharmacy 1 tube — — FDA listed —
Alocane Anti-Itch 1 g/100g 68229-0411-02 Quest 1 tube — — FDA listed —
Anti-Itch with Aloe 1 g/100g 83324-0046-01 Chain 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 58228-2045-02 ProStat 25 packets — — FDA listed —
Itch Relief 1 g/100g 69396-0057-01 Trifecta 1 tube — — 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

🏛️
2023
On the market since
Oct 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.

📊 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 NDCDescription Marketing startStatus
11383-0268-01 You're viewing this 28 g in 1 TUBE (11383-268-01) 2023-10-01 Active
11383-0268-02 59 g in 1 TUBE (11383-268-02) 2023-10-01 Active

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

Pack size FAQ

What quantity is in NDC 11383-0268-01?
NDC 11383-0268-01 contains 28 g — 28 g in 1 tube.
What is the difference between NDC 11383-0268-01 and NDC 11383-0268-02?
Both are Hydrocortisone 1 g/100g Ointment — the drug itself is identical. NDC 11383-0268-01 is the 28 g package, while NDC 11383-0268-02 is the 59 g package.
What NDC number is used to bill for this package of Hydrocortisone 1 g/100g Ointment?
Bill NDC 11383-0268-01 — the 11-digit billing format is 11383026801. 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) — 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 11383-268-01, 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: 11383-0268-01, written without dashes as 11383026801. 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 11383-0268-01, the first segment (11383) is the labeler code FDA assigned to Weeks & Leo Co., Inc.; the middle segment (0268) 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 Weeks & Leo Co., Inc.. 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 59 g (11383-0268-02). 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?
Weeks & Leo Co., Inc. 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 57 words ▾

Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis poison ivy, poison oak, and poison sumac psoriasis insect bites cosmetics jewelry detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advise and supervision of a doctor

⏱️ Dosage and Administration 85 words ▾

Directions adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor for external anal itching in adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before applying for external anal itching in children under 12 years: ask a doctor

⚠️ Warnings 142 words ▾

Warnings For external use only Do not use for the treatment of diaper rash. Ask a doctor. for external genital itching if you have a vaginal discharge. Ask a doctor. for external anal itching if rectal bleeding occurs.

Consult a doctor promptly. When using this product do not get in the eyes for external anal itching, do not use more than directed unless told to do so by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

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

🧪 Active Ingredient 4 words ▾

Active ingredient Hydrocortisone 1%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient white petrolatum

🎯 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 ↗
← 11383-0256-04 · Weeks 11383-0292-01 · Weeks →
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.