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Hydrocortisone 25 mg/g Cream — NDC 00316-0193-16 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 Cream — NDC 0316-0193-16 (Billing 00316-0193-16)

by Crown Laboratories · 1 JAR in 1 CARTON / 454 g in 1 JAR

This is a package of Hydrocortisone 25 mg/g Cream from Crown Laboratories, marketed since Jan 2016 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00316-0193-16
🏷️ FDA NDC (as labeled) 0316-0193-16 billing pads the labeler segment with a zero
This package
Contains454 g in 1 jar Pack sizes3 compare ↓
Also priced by: Part D plans $0.4138/unit — full pricing hub ↓
Main listing for product 0316-0193 · Also comes in: 20 g 0316-0193-20 30 g 0316-0193-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0316-0193-16
Product NDC 0316-0193
11-digit billing NDC 00316019316
NCPDP billing unit GM — per gram (weight)
RxCUI 106258, 310891
UNII WI4X0X7BPJ
UPC 0303160193309, 0303160186011
Application # ANDA080706
SPL Set ID a84830ad-73dc-4a2e-b987-0a1103526535
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 2016-01-06
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90550075003725
GPI class Hydrocortisone
GCN Seq No 007545
GCN 30943
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% CREAM
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007545
  • GCN: 30943
  • GPI-14 (Medi-Span): 90550075003725
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 106258
Why two NDCs? The FDA registers this code as 0316-0193-16 — 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 → 00316-0193-16. 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% CREAM 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 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 $0.4138 $187.87 / 454 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00316-0193-16 You're viewing this Main listing 1 JAR in 1 CARTON / 454 g in 1 JAR 2016-01-06 — Active
00316-0193-20 0316-0193-20 1 TUBE in 1 CARTON / 20 g in 1 TUBE 2016-01-06 — Active
00316-0193-30 0316-0193-30 1 TUBE in 1 CARTON / 30 g in 1 TUBE 2016-01-06 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 454 g in 1 jar.
What NDC number is used to bill for this package of Hydrocortisone 25 mg/g Cream?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 25 mg/g 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 —
Hydrocortisone 25 mg/g 45802-0014-02 Padagis 1 tube $0.122 AT Availability likely —
Hydrocortisone 25 mg/g 00472-0337-20 Actavis 1 tube $0.125 — Discontinued —
Hydrocortisone 25 mg/g 45802-0004-02 Padagis 1 tube $0.126 AT Availability likely —
Hydrocortisone 25 mg/g 62559-0431-30 ANI 1 tube $0.235 AT Availability likely —
Proctozone-Hc 25 mg/g 64980-0324-30 Rising 1 tube $0.235 AT Availability likely —
Procto-Med HC 25 mg/g 69315-0312-28 Leading 1 tube $0.235 AT Availability likely —
Proctosol-HC 25 mg/g 10631-0407-01 Sun 1 tube $0.698 AT Availability likely —
Alacort 25 mg/g 00316-0128-16 Crown 454 g — AT FDA listed —
Hydrocortisone 25 mg/gthis 00316-0193-16 Crown 1 jar — AT FDA listed —
Hydrocortisone 25 mg/g 50090-0244-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-0350-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-2452-00 A-S 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 50090-5999-00 A-S 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 51672-3003-00 Sun 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 61919-0364-30 DIRECT 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 63187-0480-20 Proficient 1 tube — — FDA listed —
Hydrocortisone 25 mg/g 63629-1952-01 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 63629-2396-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8666-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8667-01 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 63629-8847-01 Bryant 1 tube — AT FDA listed —
Anusol HC 25 mg/g 65649-0401-30 Salix 1 tube — 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 —
Procto-Med HC 25 mg/g 68071-3968-01 NuCare 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68071-4511-02 NuCare 20 g — — FDA listed —
Proctozone-Hc 25 mg/g 68788-7091-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8302-03 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-8583-02 Preferred 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 68788-9922-03 Preferred 1 tube — AT Discontinued —
Hydrocortisone 25 mg/g 70518-3078-00 REMEDYREPACK 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 71335-2954-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1382-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 72162-1764-03 Bryant 1 tube — AT FDA listed —
Proctozone-Hc 25 mg/g 72162-1805-02 Bryant 1 tube — AT FDA listed —
Proctosol-HC 25 mg/g 72162-2165-02 Bryant 1 tube — AT FDA listed —
Hydrocortisone Cream 25 mg/g 72189-0554-28 Direct_Rx 20 g — AT FDA listed —
Hydrocortisone Cream 25 mg/g 72189-0625-30 Direct_Rx 1 g — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0135-28 Proficient 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0081-30 Sportpharm 30 g — AT FDA listed —
Hydrocortisone 25 mg/g 85766-0085-30 Sportpharm 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-8817-01 Bryant 29 g — AT FDA listed —
Hydrocortisone 25 mg/g 82804-0084-20 Proficient 1 tube — AT FDA listed —
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 72162-1383-04 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-9057-01 Bryant 1 tube — AT FDA listed —
Hydrocortisone 25 mg/g 63629-2528-01 Bryant 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

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

8 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

LabelerCrown Laboratories
Application holderCROWN LABORATORIES INC
FDA applicationANDA080706 (ANDA)
Labeler code00316
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio43 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. 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

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

⏱️ Dosage and Administration 59 words ▾

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to four 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 Topcial corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 77 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. To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/

🤰 Pregnancy 96 words ▾

Pregnancy: Teratogenic effects - Pregnancy Category C 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 117 words ▾

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenaI (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children 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 17 words ▾

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systems effects (See PRECAUTIONS ).

🧬 Clinical Pharmacology 60 words ▾

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic 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.

📦 How Supplied / Storage and Handling 61 words ▾

HOW SUPPLIED Hydrocortisone Cream USP, 1% is supplied in: 1 ounce (28.4 grams) tube NDC 0316-0186-01 454 grams jar NDC 0316-0186-16 Hydrocortisone Cream USP, 2.5% is supplied in: 20 grams tube NDC 0316-0193-20 30 grams tube NDC 0316-0193-30 454 grams jar NDC 0316-0193-16 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA ​Revised Dec 2017 P6306.03

📦 Storage and Handling 22 words ▾

PACKAGING AND STORAGE Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].

📋 Description 123 words ▾

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-.

Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of Hydrocortisone Cream USP, 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. hcstructure

💬 Information for Patients 127 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 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.

🍼 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.

🧬 Pharmacokinetics 132 words ▾

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.

📄 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 ~3 min read ▾

Hydrocortisone Cream USP, 1% - 1oz Label NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use.

1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information.

TO OPEN: Use cap to pucture seal. IMPORTANT: Do not use if seal has been puctured or is not visible. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature].

See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6300.01 HC1% 1oz tube

Hydrocortisone Cream USP, 1% -1oz Carton NDC 0316-0186-01 Rx Only Hydrocortisone Cream USP, 1% Warning: Keep out of reach of children. For external use only. Not for ophthalmic use.

1oz (28.4 grams) Each gram contains: 10 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal.

Push cap down until seal is punctured. Screw cap back on to reseal tube. Store at 20 o -25 o C (68 o -77 o F)[see USP Controlled Room Temperature].

Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date.

Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P6304.02 HC1%-1oz-carton

Hydrocortisone Cream USP, 2.5% 30 grams Label NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% 30 grams WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use.

Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information.

TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°C-25°C (68°-77°F) [see USP Controlled Room Temperature].

See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11337.00 HC 2.5% 30g tube

Hydrocortisone Cream USP, 2.5% 30 grams Carton NDC 0316-0193-30 Rx Only Hydrocortisone Cream USP, 2.5% WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use.

30 grams Each gram contains: 25 mg Hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Usual Dosage: 2 to 4 applications daily. See package insert for full prescribing information.

Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured.

Screw cap back on to reseal tube. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P11338.00 HC 2.5% 30g carton

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

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.

About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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

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 Crown Laboratories. 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 2 other package presentations of this same product, including 1 tube (00316-0193-20), 1 tube (00316-0193-30). 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?
Crown Laboratories 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00316-0186-01 · Crown 00316-0221-15 · Crown →
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.