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Hydrocortisone 25 mg/g Ointment, 454 g — NDC 00168-0146-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocortisone 25 mg/g Ointment, 454 g — NDC 0168-0146-16 (Billing 00168-0146-16)

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 454 g in 1 JAR

This is a package of 454 g of Hydrocortisone 25 mg/g Ointment from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since May 1993 and currently FDA-listed; retail pharmacies pay about $0.0985 per g (NADAC).

NDC 00168-0146-16
🏷️ FDA NDC (as labeled) 0168-0146-16 billing pads the labeler segment with a zero
This package
Contains454 g Cost per g$0.0985 NADAC Per package$44.72 / 454 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1080/unit · Part D plans $0.1782/unit — full pricing hub ↓
Product page 00168-0146-30 Also comes in: 29 g 0168-0146-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1045-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0168-0146-16
Product NDC 0168-0146
11-digit billing NDC 00168014616
NCPDP billing unit GM — per gram (weight)
RxCUI 103401, 310891
UNII WI4X0X7BPJ
UPC 0301680146300, 0301680080314
Application # ANDA081203
SPL Set ID bcd103f3-3dc8-4394-b8fd-8f8ddb721f77
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-05-28
Route TOPICAL
Dosage form OINTMENT
Substance HYDROCORTISONE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90550075004215
GPI class Hydrocortisone
GCN Seq No 007548
GCN 30952
HICL code 002867
Ingredient (HICL) Hydrocortisone
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name HYDROCORTISONE 2.5% OINTMENT
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007548
  • GCN: 30952
  • GPI-14 (Medi-Span): 90550075004215
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 103401
Why two NDCs? The FDA registers this code as 0168-0146-16 — a 4-4-2 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 labeler segment → 00168-0146-16. 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

Label name HYDROCORTISONE 2.5% OINTMENT Ingredient Hydrocortisone
📖 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 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 →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 gPer package
Retail pharmacies payNADAC · weekly $0.099 $44.72 / 454 g
Medicaid paysCMS SDUD · 12 mo $0.1080 $49.03 / 454 g
Medicare drug plans payPart D · Q2 2026 $0.1782 $80.90 / 454 g
NADAC price history (per g) — tap or hover for the price & month
Feb 2025 $0.099 $0.099
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 Per unit Per pack Marketing startMarketing endStatus
00168-0146-16 You're viewing this 454 g in 1 JAR $0.0985 / g $44.72 1993-05-28 — Active
00168-0146-30 0168-0146-30 Main listing 29 g in 1 TUBE $0.0955 / g $2.77 1993-05-28 — Active

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

Per g, this pack runs about 3% above the cheapest pack (29 g, $0.0955 vs $0.0985 NADAC).

This pack accounts for about 1.2% of this product's recent Medicaid fills; most go to the 29 g pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 454 g — 454 g in 1 jar.
How does this package differ from NDC 00168-0146-30?
Both are Hydrocortisone 25 mg/g Ointment — the drug itself is identical. This page's package is the 454 g one, while NDC 00168-0146-30 is the 29 g package. Per-g NADAC also differs: $0.0985 here vs $0.0955 for the 29 g pack.
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 25 mg/gthis 00168-0146-16 E. 454 g $0.099 AT FDA listed —
Hydrocortisone 25 mg/g 00168-0080-16 E. 454 g $0.109 AT Availability likely +11%
Hydrocortisone 25 mg/g 45802-0014-02 Padagis 1 tube $0.122 AT Availability likely +24%
Hydrocortisone 25 mg/g 00472-0337-20 Actavis 1 tube $0.125 — Discontinued +27%
Hydrocortisone 25 mg/g 45802-0004-02 Padagis 1 tube $0.126 AT Availability likely +27%
Hydrocortisone 25 mg/g 62559-0431-30 ANI 1 tube $0.235 AT Availability likely +139%
Procto-Med HC 25 mg/g 69315-0312-28 Leading 1 tube $0.235 AT Availability likely +139%
Proctosol-HC 25 mg/g 10631-0407-01 Sun 1 tube $0.698 AT Availability likely +609%
Hydrocortisone 25 mg/g 50090-0527-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2527-01 Bryant 454 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2528-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8817-01 Bryant 29 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-9057-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1383-04 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0084-20 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63187-0480-20 Proficient 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 50090-5999-00 A-S 1 tube — — FDA listed —
Anusol HC 25 mg/g 65649-0401-30 Salix 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 61919-0364-30 DIRECT 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 66267-0967-01 NuCare 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 68071-2233-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1382-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-2452-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-9922-03 Preferred 1 tube — AT Discontinued —
Hydrocortisone 25 mg/g 50090-0350-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0081-30 Sportpharm 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8667-01 Bryant 1 tube — AT FDA listed —
Alacort 25 mg/g 00316-0128-16 Crown 454 g — AT FDA listed —
Hydrocortisone 25 mg/g 00316-0193-16 Crown 1 jar — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8583-02 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1764-03 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0085-30 Sportpharm 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-1952-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68071-4511-02 NuCare 20 g — — FDA listed —
Hydrocortisone 25 mg/g 71335-2954-01 Bryant 1 tube — AT FDA listed —
Procto-Med HC 25 mg/g 68071-3968-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 70518-3078-00 REMEDYREPACK 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8302-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-0244-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 51672-3003-00 Sun 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8666-01 Bryant 1 tube — AT FDA listed —
Proctosol-HC 25 mg/g 72162-2165-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0135-28 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 21922-0065-05 Encube 1 tube — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
1993
On the market since
May 1993
📍
2026
Currently FDA-listed
33 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

💡 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

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

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

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA081203 (ANDA)
Labeler code00168
First marketedMay 1993
Product typeHuman Prescription Drug
Portfolio33 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 54 words ▾

DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 60 words ▾

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

🤰 Pregnancy 92 words ▾

Pregnancy: Teratogenic Effects –Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.

Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use 119 words ▾

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

🆘 Overdosage 18 words ▾

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTION S ).

🧬 Clinical Pharmacology 193 words ▾

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics : The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED Hydrocortisone Cream USP, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g Tubes NDC 0168-0146-30 28.35 g (1 oz) Tubes NDC 0168-0080-16 453.6 g (1 Lb) Jars NDC 0168-0146-16 453.6 g (1 Lb) Jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 Rev. 07/2024

📋 Description 122 words ▾

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone Cream USP, 2.5% and Hydrocortisone Ointment USP, 2.5% contains hydrocortisone, USP. Hydrocortisone is a white to practically white crystalline powder.

Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is: Molecular Formula: C 21 H 30 O 5 Molecular Weight: 362.47 Each gram of the 2.5% Cream contains 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. chemical-structure

💬 Information for Patients 128 words ▾

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician.

It is for external use only. Avoid contact with the eyes. 2.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory tests: The following tests may be helpful in evaluating HPA axis suppression: Urinary free cortisol test; ACTH stimulation test. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy: Teratogenic Effects –Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater suscep… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 58 words ▾

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

📄 Package Label / Principal Display Panel 193 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CONTAINER NDC 0168-0146-30 Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. Net Wt. 28.35 g (1 Oz) tube-ont

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CARTON NDC 0168-0146-30 Rx only Hydrocortisone Ointment USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 28.35 g (1 Oz) carton-ont

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CONTAINER NDC 0168-0080-31 Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Rx only Each gram for topical administration contains: 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Net Wt. 30 grams tube-crm

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GM CARTON NDC 0168-0080-31 Rx only Hydrocortisone Cream USP, 2.5% For External Use Only Not for Ophthalmic Use FOUGERA ® Net Wt. 30 grams carton-crm

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

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 this package alone, 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 – Q1 2026 · 5 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
5.6K
Units reimbursed last 4 qtrs
2.4M
Gross reimbursed last 4 qtrs
$256.8K
Avg / prescription
$45.97
Avg / unit
$0.1080
Latest quarter Q1 2026
1.5KRx
Medicaid pays / g
$0.1080
gross reimbursed
vs
NADAC / g
$0.0985
acquisition cost
=
Spread
+$0.0095
+10% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 2,270 Rx Managed care · 3,315 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 32,976 units · 575 per 100k residents MN Wisconsin: 105,220 units · 1,780 per 100k residents WI Michigan: 31,476 units · 314 per 100k residents MI New York: 304,976 units · 1,558 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 38,252 units · 305 per 100k residents IL Indiana: no data reported IN Ohio: 56,700 units · 481 per 100k residents OH Pennsylvania: 143,273 units · 1,105 per 100k residents PA New Jersey: 418 units · 4.5 per 100k residents NJ Massachusetts: 5,897 units · 84.2 per 100k residents MA California: 295,352 units · 758 per 100k residents CA Utah: no data reported UT Colorado: 9,072 units · 154 per 100k residents CO Nebraska: no data reported NE Missouri: 218,239 units · 3,522 per 100k residents MO Kentucky: 15,451 units · 341 per 100k residents KY West Virginia: no data reported WV Virginia: 45,736 units · 525 per 100k residents VA Maryland: 142,688 units · 2,309 per 100k residents MD Connecticut: 18,753 units · 518 per 100k residents CT Rhode Island: no data reported RI Arizona: 21,106 units · 284 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 15,483 units · 217 per 100k residents TN North Carolina: 61,729 units · 570 per 100k residents NC South Carolina: no data reported SC Delaware: 4,142 units · 402 per 100k residents DE Oklahoma: 5,897 units · 145 per 100k residents OK Louisiana: 2,954 units · 64.6 per 100k residents LA Mississippi: 25,594 units · 871 per 100k residents MS Alabama: no data reported AL Georgia: 46,868 units · 425 per 100k residents GA D.C.: 5,107 units · 752 per 100k residents DC Hawaii: no data reported HI Texas: 661,922 units · 2,170 per 100k residents TX Florida: 62,686 units · 277 per 100k residents FL
Units reimbursed · per 100k residents
4.53,522
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
🏆 Top states by units · per 100k residents
1 Missouri 3,522 /100k
2 Maryland 2,309 /100k
3 Texas 2,170 /100k
4 Wisconsin 1,780 /100k
5 New York 1,558 /100k
6 Pennsylvania 1,105 /100k
7 Mississippi 871 /100k
8 California 758 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
29 g00168-0146-30 473,917 Rx · $5,005,655
454 g this page00168-0146-16 5,585 Rx · $256,753
Drug total (last 4 qtrs): 479,502 Rx · 18,144,947 units · $5,262,408 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 00168-0134-60 · E. 00168-0162-15 · E. →
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.