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Hydrocortisone 10 mg/g Ointment, 453.6 g — NDC 00168-0020-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrocortisone 10 mg/g Ointment, 453.6 g — NDC 0168-0020-16 (Billing 00168-0020-16)

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 453.6 g in 1 JAR

This is a package of 453.6 g of Hydrocortisone 10 mg/g Ointment from E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, marketed since Apr 1975 and currently FDA-listed; retail pharmacies pay about $0.1379 per g (NADAC).

NDC 00168-0020-16
🏷️ FDA NDC (as labeled) 0168-0020-16 billing pads the labeler segment with a zero
This package
Contains453.6 g Cost per g$0.1379 NADAC Per package$62.55 / 453.6 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1247/unit · Part D plans $0.1730/unit — full pricing hub ↓
Product page 00168-0020-31 Also comes in: 28.35 g 0168-0020-31
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

NDC database record

One package, one record: these facts belong to NDC 0168-0020-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0168 labeler · 0020 product · 16 package
Package marketed since
Apr 16, 1975
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
454 g per package
Barcode (UPC-A, from the NDC)
3 0168002016 7
Medicaid fills, this package
17,278 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0168-0020-16
Product NDC 0168-0020
11-digit billing NDC 00168002016
NCPDP billing unit GM — per gram (weight)
RxCUI 203105
UNII WI4X0X7BPJ
Application # ANDA080692
SPL Set ID 31fbb576-0e76-471c-83c8-9e0125bc1791
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 1975-04-16
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 90550075004210
GPI class Hydrocortisone
GCN Seq No 007547
GCN 30951
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 1% OINTMENT
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007547
  • GCN: 30951
  • GPI-14 (Medi-Span): 90550075004210
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 203105
Why two NDCs? The FDA registers this code as 0168-0020-16 — 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 → 00168-0020-16. 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 1% 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 $0.138 $62.55 / 453.6 g
Medicaid paysCMS SDUD · 12 mo $0.1247 $56.56 / 453.6 g
Medicare drug plans payPart D · Q2 2026 $0.1730 $78.47 / 453.6 g
NADAC price history (per g) — tap or hover for the price & month
Jun 2025 Jun 2026 Jul 2026 Sep 2026 $0.138 $0.126
▲ Up 9% over the last 5 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00168-0020-16 You're viewing this 453.6 g in 1 JAR $0.1379 / g $62.56 1975-04-16 — Active
00168-0020-31 0168-0020-31 Main listing 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE $0.1545 / g $4.38 1975-04-16 — Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.1379 NADAC).

This pack accounts for about 13% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 453.6 g — 453.6 g in 1 jar.
How does this package differ from NDC 00168-0020-31?
Both are Hydrocortisone 10 mg/g Ointment — the drug itself is identical. This page's package is the 453.6 g one, while NDC 00168-0020-31 is the 1 tube package. Per-g NADAC also differs: $0.1379 here vs $0.1545 for the 1 tube pack.
What NDC number is used to bill for this package of Hydrocortisone 10 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 1 g/100g 45802-0276-03 Padagis 1 tube $0.070 — Availability likely save 49%
Good Neighbor Pharmacy Hydrocortisone 1 g/100g 24385-0276-03 AmerisourceBergen 1 tube $0.077 — Availability likely save 44%
sunmark Hydrocortisone 1 g/100g 49348-0522-72 Strategic 1 tube $0.077 — Availability likely save 44%
Hydrocortisone 1 g/100g 51672-2018-02 Sun 1 tube $0.077 — Availability likely save 44%
Hydrocortisone 1 g/100g 70677-1214-01 STRATEGIC 1 tube $0.077 — Availability likely save 44%
hydrocortisone 10 mg/g 00168-0015-16 E. 453.6 g $0.109 AT Availability likely save 21%
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely save 18%
Hydrocortisone 10 mg/gthis 00168-0020-16 E. 453.6 g $0.138 AT Availability likely —
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.600 AT Availability likely +335%
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/100g 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 —
Proctocort 10 mg/g 65649-0501-30 Salix 1 tube — AT Discontinued —
Dr. Sheffield Hydrocortisone Anti itch 10 mg/g 11527-0052-51 Sheffield 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Anti Itch 10 mg/g 49967-0108-01 L'Oreal 1 tube — — FDA listed —
SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g 70288-0173-00 Ana-Cool, 56.7 g — — FDA listed —
Ana Cool Rapid Soothing Cooling Formula 10 mg/g 70288-0714-01 Ana-Cool, 1 bottle — — FDA listed —
Thera plus Anti-itch with aloe Hydrocortisone 10 mg/g 80684-0038-01 Fourstar 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 73141-0622-28 A2A 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0145-00 Fourstar 42.5 g — — FDA listed —
Cortizone 10 Cooling Relief 10 mg/g 41167-0036-00 Chattem, 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0397-35 Unifirst 144 packets — — FDA listed —
Quadrydern 10 mg/g 59428-0403-57 Productos 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 00924-1133-00 Acme 9 g — — FDA listed —
Alacort 10 mg/g 00316-0126-01 Crown 1 tube — AT FDA listed —
Hydrocortisone 10 mg/g 00316-0186-01 Crown 1 tube — AT FDA listed —
Winco Maximum Strength Hydrocortisone 10 mg/g 67091-0197-28 WINCO 1 tube — — FDA listed —
CVS Health Hydrocortisone Anti Itch 10 mg/g 69842-0155-10 CVS 24 packets — — Discontinued —
Aveeno 1% Hydrocortisone Anti-Itch Cream 10 mg/g 69968-0888-01 Kenvue 1 tube — — FDA listed —
Thera Plus Hydrocortisone Maximum Strength 10 mg/g 80684-0151-00 FOURSTAR 42.5 g — — FDA listed —
Quality Choice 10 mg/g 83324-0297-01 Chain 1 tube — — FDA listed —
Cortizone 10 10 mg/g 41167-0039-00 Chattem, 1 tube — — Discontinued —
Hydrocortisone 10 mg/g 51316-0227-00 CVS 1 tube — — FDA listed —
Crane Safety Hydrocortisone 10 mg/g 73408-0933-73 Crane 25 packets — — FDA listed —
Cortizone 10 Intensive Healing for Eczema 10 mg/g 41167-0331-00 Chattem, 1 tube — — FDA listed —
Family Wellness Max Strength 1 Hydrocortisone Cream 10 mg/g 55319-0982-00 Family 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 63629-1951-01 Bryant 1 tube — AT FDA listed —
Barmicil Plus 10 mg/g 69729-0103-11 OPMX 28 g — — FDA listed —
Hydrocortisone 10 mg/g 72162-1763-02 Bryant 1 tube — AT FDA listed —
THERAPLEX AIM Anti-Itch Moisturizing 10 mg/g 82280-0478-02 THERAPLEX, 56.7 g — — FDA listed —
Hydrocortisone 10 mg/g 82942-1003-01 J&A 9 g — — FDA listed —
Itch and Rash Cream 10 mg/g 84269-4506-01 Wildman 25 packets — — FDA listed —
Hydrocortisone 10 mg/g 85766-0166-10 Sportpharm 10 pouches — — FDA listed —
Hydrocortisone 10 mg/g 43473-0049-01 Nantong 9 g — — FDA listed —
SurviveX Hydrocortisone Cream 10 mg/g 43473-0313-01 Nantong 9 g — — FDA listed —
DermaCort Anti-itch 10 mg/g 54473-0117-28 Melaleuca, 28 g — — FDA listed —
Hydrocortisone 10 mg/g 00363-9981-02 Walgreens 1 tube — — FDA listed —
Cortizone 10 Intensive Healing 10 mg/g 41167-0035-00 Chattem, 1 tube — — FDA listed —
Thompson Hydrocortisone 1% 10 mg/g 73408-0937-73 Thompson 25 packets — — FDA listed —
Preparation H Soothing Relief Anti-Itch 10 mg/g 00573-0552-11 Haleon 1 tube — — FDA listed —
Equate Hydrocortisone 10 mg/g 79903-0092-01 WalMart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0211-12 Unifirst 10 pouches — — FDA listed —
Hydrocortisone anti-itch plus 10 mg/g 49035-0732-02 Wal-Mart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 51316-0230-00 CVS 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 72189-0209-28 DIRECT 28.4 g — AT FDA listed —
First Aid Only Hydrocortisone 1% Anti-Itch 10 mg/g 00924-5633-00 Acme 9 g — — FDA listed —
ProCure Hydrocortisone Cream Plus 10 mg/g 29784-0142-28 Rooftop 1 tube — — FDA listed —
Anti-itch 10 mg/g 53329-0091-01 Medline 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 61010-5800-02 Safetec 144 pouches — — FDA listed —
Aveeno Hydrocortisone ANTI-ITCH 10 mg/g 69968-0511-01 Kenvue 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0197-00 Fourstar 6 packets — — FDA listed —
Hydrocortisone 10 mg/g 84387-0005-01 ALLIED 28.4 g — — FDA listed —
WinCo Foods Hydrocortisone Cream Intensive Healing 10 mg/g 67091-0419-28 WINCO 1 tube — — FDA listed —
TheraCare Hydrocortisone Cream 10 mg/g 71101-0220-01 Veridian 1 tube — — FDA listed —
Preparation H Hydrocortisone 10 mg/g 00573-2830-10 Haleon 1 tube — — FDA listed —
Thera Plus Eczema Hydrocortisone Anti Itch 10 mg/g 80684-0146-00 Fourstar 28 g — — FDA listed —
FifthPulse Hydrocortisone 10 mg/g 87525-0003-01 WeCare 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0933-73 Unifirst 25 pouches — — FDA listed —
Hydrocortisone 1% Anti-ItchCream 10 mg/g 00924-5634-00 Acme 9 g — — FDA listed —
Drs. Hydrocortisone Aloe Vera 10 mg/g 80489-0088-01 OL 1 tube — — FDA listed —
Quadriderm NF 10 mg/g 69729-0828-02 OPMX 1 tube — — FDA listed —
Diprospan 10 mg/g 69729-0794-02 OPMX 1 tube — — FDA listed —
Barmicil Plus 10 mg/g 69729-0830-01 OPMX 1 tube — — FDA listed —
Aerosoothe 10 mg/g 55305-0136-02 Aero 25 packets — — FDA listed —
Barmicil Plus 10 mg/g 69729-0834-01 OPMX 1 tube — — FDA listed —
Terramed Just Think Comfort Hydrocortisone 1% Cream 10 mg/g 83004-0051-01 Rida 1 jar — — 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

🏛️
1975
On the market since
Apr 1975
📍
2026
Currently FDA-listed
51 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 applicationANDA080692 (ANDA)
Labeler code00168
First marketedApr 1975
Product typeHuman Prescription Drug
Portfolio33 products on file

More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168

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 🧬 Pharmacokinetics 📄 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 59 words ▾

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film three or four times a day 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 114 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-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children 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 children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology 192 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 then are excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted by the bile.

📦 How Supplied / Storage and Handling 51 words ▾

HOW SUPPLIED Hydrocortisone Ointment USP, 1% is supplied as follows: NDC 0168-0020-31 28.35 g (1 Oz) Tubes NDC 0168-0020-16 453.6 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 42 words ▾

DESCRIPTION Hydrocortisone Ointment USP, 1% contains hydrocortisone [Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11ß)-], with the molecular formula C 21 H 30 O 5 and molecular weight 362.47. Each gram contains 10 mg of hydrocortisone, USP in a base containing white petrolatum and mineral oil. structure

💬 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.

⚠️ 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 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 the 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 susceptibil… [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.

🧬 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 then are excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted by 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 34 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1LB CONTAINER NDC 0168-0020-16 Hydrocortisone Ointment USP, 1% Rx only For External Use Only Not For Ophthalmic Use Net Wt. 453.6 g (1 lb) FOUGERA ® jar-lbl

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
17.3K
Units reimbursed last 4 qtrs
7.6M
Gross reimbursed last 4 qtrs
$952.9K
Avg / prescription
$55.15
Avg / unit
$0.1247
Latest quarter Q1 2026
6.7KRx
Medicaid pays / g
$0.1247
gross reimbursed
vs
NADAC / g
$0.1379
acquisition cost
=
Spread
−$0.0132
-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 ⓘ
42% FFS 58% MCO
Fee-for-service · 7,251 Rx Managed care · 10,027 Rx
State Medicaid map
Alaska: no data reported AK Maine: 5,443 units · 390 per 100k residents ME Washington: 41,731 units · 534 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 54,387 units · 948 per 100k residents MN Wisconsin: 207,630 units · 3,513 per 100k residents WI Michigan: 208,010 units · 2,072 per 100k residents MI New York: 755,698 units · 3,861 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 4,990 units · 118 per 100k residents OR Nevada: 20,866 units · 653 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 17,720 units · 553 per 100k residents IA Illinois: 126,160 units · 1,005 per 100k residents IL Indiana: 132,736 units · 1,934 per 100k residents IN Ohio: 485,352 units · 4,118 per 100k residents OH Pennsylvania: 498,444 units · 3,846 per 100k residents PA New Jersey: 4,172 units · 44.9 per 100k residents NJ Massachusetts: 423,212 units · 6,045 per 100k residents MA California: 1,312,810 units · 3,369 per 100k residents CA Utah: no data reported UT Colorado: 20,865 units · 355 per 100k residents CO Nebraska: no data reported NE Missouri: 455,254 units · 7,348 per 100k residents MO Kentucky: 104,601 units · 2,311 per 100k residents KY West Virginia: no data reported WV Virginia: 280,069 units · 3,213 per 100k residents VA Maryland: 301,171 units · 4,873 per 100k residents MD Connecticut: 144,726 units · 4,001 per 100k residents CT Rhode Island: 77,112 units · 7,042 per 100k residents RI Arizona: 65,772 units · 885 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 174,041 units · 2,442 per 100k residents TN North Carolina: 136,453 units · 1,259 per 100k residents NC South Carolina: 45,814 units · 853 per 100k residents SC Delaware: 7,258 units · 704 per 100k residents DE Oklahoma: no data reported OK Louisiana: 42,668 units · 933 per 100k residents LA Mississippi: 89,109 units · 3,031 per 100k residents MS Alabama: 39,463 units · 773 per 100k residents AL Georgia: 361,074 units · 3,274 per 100k residents GA D.C.: 15,961 units · 2,351 per 100k residents DC Hawaii: no data reported HI Texas: 638,126 units · 2,092 per 100k residents TX Florida: 341,107 units · 1,509 per 100k residents FL
Units reimbursed · per 100k residents
44.97,348
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 7,348 /100k
2 Rhode Island 7,042 /100k
3 Massachusetts 6,045 /100k
4 Maryland 4,873 /100k
5 Ohio 4,118 /100k
6 Connecticut 4,001 /100k
7 New York 3,861 /100k
8 Pennsylvania 3,846 /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.
1 tube00168-0020-31 116,825 Rx · $1,227,722
453.6 g this page00168-0020-16 17,278 Rx · $952,877
Drug total (last 4 qtrs): 134,103 Rx · 11,682,079 units · $2,180,599 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.
← 00168-0015-16 · E. 00168-0033-15 · 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.