HomeNDC LookupIngredientsHydrocortisone › 00168-0015-16
hydrocortisone 10 mg/g Cream, 453.6 g — NDC 00168-0015-16 package photo

hydrocortisone 10 mg/g Cream, 453.6 g

by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC · 453.6 g in 1 JAR (0168-0015-16)
NDC 00168-0015-16
🏷️ FDA NDC (as labeled) 0168-0015-16 billing pads the labeler segment with a zero
This package
Contains453.6 g Cost per g$0.1128 NADAC Per package$51.17 / 453.6 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0816/unit · Part D plans $0.4138/unit — full pricing hub ↓
Also comes in: 28.35 g 00168-0015-31
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0168-0015-16
Product NDC 0168-0015
11-digit billing NDC 00168001516
NCPDP billing unit GM — per gram (weight)
RxCUI 106258
UNII WI4X0X7BPJ
UPC 0301680015316
Application # ANDA080693
SPL Set ID bc374fa4-ac8b-408e-9321-8bab97a18770
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 1976-04-30
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
GPI-14 90550075003720
GPI class Hydrocortisone
GCN Seq No 007544
GCN 30942
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% CREAM
FDB brand name Hydrocortisone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0168-0015-16 — 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 → 00168-0015-16. 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.

🏭 Manufacturer & labeler

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA080693 (ANDA)
Labeler code00168
First marketedApr 1976
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.

🩺 Clinical

Label name HYDROCORTISONE 1% 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's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 Read our full Hydrocortisone guide →
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.

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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII 13A4J4NH9I
    A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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.

11 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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.113 $51.17 / 453.6 g
Medicaid paysCMS SDUD · 12 mo $0.0816 $37.01 / 453.6 g
Medicare drug plans payPart D · Q2 2026 $0.4138 $187.70 / 453.6 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.117 $0.113
▼ Down 2% over the last 9 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Hydrocortisone With Aloe .01 g/g 70000-0543-01 LEADER 1 tube $0.056 FDA listed save 50%
Hydrocortisone Cream with Aloe 1 g/100g 00536-1407-95 Rugby 1 tube $0.058 Availability likely save 49%
Hydrocortisone Cream with Aloe 1 g/100g 70000-0662-01 Cardinal 1 tube $0.058 Availability likely save 49%
Good Neighbor Pharmacy Hydrocortisone with Aloe 1 g/100g 24385-0274-03 AmerisourceBergen 1 tube $0.059 Availability likely save 48%
good sense anti itch 1 g/100g 00113-0541-64 L. 1 tube $0.062 Availability likely save 45%
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers 1 g/100g 24385-0021-03 AmerisourceBergen 1 tube $0.062 Availability likely save 45%
hydrocortisone 1 g/100g 45802-0438-03 Padagis 1 tube $0.062 Availability likely save 45%
Hydrocortisone Plus 12 Moisturizers 1 g/100g 51672-2063-02 Sun 1 tube $0.062 Availability likely save 45%
Hydrocortisone Acetate Antipruritic (Anti-Itch) 1 g/100g 51672-2069-02 Sun 1 tube $0.062 Availability likely save 45%
Hydrocortisone 1 g/100g 68001-0476-46 BluePoint 1 tube $0.062 Availability likely save 45%
Hydrocortisone 1 g/100g 70000-0485-01 Cardinal 1 tube $0.062 Availability likely save 45%
Hydrocortisone 1% 1 g/100g 83324-0047-01 Chain 1 tube $0.062 Availability likely save 45%
Itch Relief 1 g/100g 70677-1215-01 STRATEGIC 1 tube $0.070 Availability likely save 38%
Hydrocortisone with Aloe 1 g/100g 70677-1216-01 STRATEGIC 1 tube $0.070 Availability likely save 38%
Sunmark Hydrocortisone with Aloe Maximum Strength 1 g/100g 49348-0521-72 Strategic 1 tube $0.093 Discontinued save 18%
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely +0%
hydrocortisone 10 mg/gthis 00168-0015-16 E. 453.6 g $0.113 AT Availability likely
Hydrocortisone with Aloe 1 g/100g 51672-2013-01 Sun 1 tube $0.130 Availability likely +15%
Hydrocortisone with Aloe 1 g/100g 51672-5330-01 Sun 1 tube $0.130 Availability likely +15%
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.134 AT Availability likely +19%
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.569 AT Availability likely +404%
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
Hydrocortisone Cream Intensive Healing 1 g/100g 00363-0237-03 Walgreens 1 tube FDA listed
Maximum Strength Hydrocortisone Cream with Aloe 1 g/100g 00363-0620-03 Walgreens 1 tube FDA listed
Maximum Strength Hydrocortisone Cream 1 g/100g 00363-0638-04 Walgreens 1 tube FDA listed
Hydrocortisone 1 g/100g 00363-0972-02 Walgreen 1 tube FDA listed
Hydrocortisone 1 g/100g 00363-1973-16 Walgreen 1 tube FDA listed
Hydrocortisone 10 mg/g 00363-9981-02 Walgreens 1 tube FDA listed
Hydrocortisone 1 g/100g 00404-0166-50 Henry 1 tube FDA listed
Hydrocortisone 10 mg/g 00924-1133-00 Acme 9 g FDA listed
First Aid Only Hydrocortisone 1% Anti-Itch 10 mg/g 00924-5633-00 Acme 9 g FDA listed
Anti itch 1 g/100g 11383-0292-01 Weeks 28 g FDA listed
Anti-itch Paraben Free 1 g/100g 11383-0313-01 Weeks 1 tube FDA listed
Dr. Sheffield Hydrocortisone Anti itch 10 mg/g 11527-0052-51 Sheffield 1 tube FDA listed
Hydrocortisone Intensive Healing Formula 1 g/100g 11673-0398-02 TARGET 1 tube FDA listed
Hydrocortisone Plus 12 Moisturizers 1 g/100g 11673-0399-02 TARGET 1 tube FDA listed
up and up hydrocortisone anti itch 1 g/100g 11673-0842-00 Target 2 tubes Discontinued
Maximum Strength Hydrocortisone Anti-itch 10 mg/g 11673-0890-56 Target 2 tubes FDA listed
Hydrocortisone 1 g/100g 11822-2069-02 Rite 1 tube FDA listed
Hydrocortisone Plus 12 Moisturizers 1 g/100g 11822-2090-02 RITE 1 tube FDA listed
Rite Aid anti-itch 1 g/100g 11822-2099-03 Rite 1 tube FDA listed
Rite Aid Anti-itch 1 g/100g 11822-3130-01 Rite 1 tube FDA listed
Signature Care Anti Itch 1 g/100g 21130-0278-64 Safeway 1 tube FDA listed
Signature Care Hydrocortisone 1 g/100g 21130-0369-64 Safeway 1 tube FDA listed
Signature Care Hydrocortisone 1 g/100g 21130-0395-16 Safeway 1 tube FDA listed
Anti Itch 1 g/100g 21130-0433-64 Safeway 1 tube FDA listed
hydrocortisone 1 g/100g 21130-0449-16 Safeway 1 tube FDA listed
Signature Care Hydrocortisone 1 g/100g 21130-0993-64 Safeway 1 tube FDA listed
Hydrocortisone 1 g/100g 21922-0096-04 Encube 1 tube FDA listed
Hydrocortisone with aloe 1 g/100g 21922-0097-04 Encube 1 tube FDA listed
Hydrocortisone 1% Anti-Itch Cream 1 g/100g 24286-1578-01 DLC 1 tube FDA listed
ProCure Hydrocortisone Cream Plus 10 mg/g 29784-0142-28 Rooftop 1 tube FDA listed
hydrocortisone 1 1 g/100g 30142-0369-64 Kroger 1 tube FDA listed
Hydrocortisone 1 g/100g 30142-0411-16 Kroger 1 tube FDA listed
hydrocortisone 1 g/100g 30142-0973-64 Kroger 1 tube FDA listed
TopCare Hydrocortisone Plus 12 Moisturizers 1 g/100g 36800-0051-06 Topco 1 tube FDA listed
TopCare Hydrocortisone Intensive Healing Formula 1 g/100g 36800-0099-02 Topco 1 tube FDA listed
topcare hydrocortisone 1 g/100g 36800-0524-26 Topco 2 tubes FDA listed
topcare hydrocortisone 1 g/100g 36800-0939-64 Topco 1 tube FDA listed
Topcare Hydrocortisone 1 g/100g 36800-0981-64 Topco 1 tube FDA listed
Shopko Hydrocortisone Maximum Strength 1 g/100g 37012-0059-02 Shopko 1 tube FDA listed
Hydrocortisone 1 g/100g 37808-0319-64 H 1 tube FDA listed
hydrocortisone anti itch 1 g/100g 37808-0369-64 H 1 tube FDA listed
hydrocortisone 1 g/100g 37808-0973-64 H 1 tube FDA listed
equaline anti itch 1 g/100g 41163-0319-16 United 1 tube FDA listed
equaline anti itch maximum strength 1 g/100g 41163-0369-64 United 1 tube FDA listed
equaline anti itch maximum strength 1 g/100g 41163-0973-64 United 1 tube FDA listed
Cortizone-10 Soothing Aloe Creme 1 g/100g 41167-0021-00 Chattem, 1 tube FDA listed
Cortisone 10 Intensive Moisture Creme 1 g/100g 41167-0022-00 Chattem, 1 tube FDA listed
Cortizone 10 Intensive Healing Itch Relief Cream 1 g/100g 41167-0023-00 Chattem, 1 tube FDA listed
Cortizone 10 Soothing Aloe Itch Relief 1 g/100g 41167-0024-00 Chattem, 1 tube FDA listed
Cortizone 10 Ultra Soothing Creme 1 g/100g 41167-0027-00 Chattem, 1 tube FDA listed
Cortisone 10 Sensitive Skin Creme 1 g/100g 41167-0028-00 Chattem, 1 tube FDA listed
Cortizone 10 Ultra Soothing Itch Relief 1 g/100g 41167-0029-00 Chattem, 1 tube FDA listed
Cortizone 10 Intensive Healing 10 mg/g 41167-0035-00 Chattem, 1 tube FDA listed
Cortizone 10 10 mg/g 41167-0039-00 Chattem, 1 tube Discontinued
Cortisone 10 Overnight Creme 1 g/100g 41167-0109-02 Chattem, 1 tube FDA listed
Cortizone 10 Feminine Itch Relief 1 g/100g 41167-0330-03 Chattem, 1 tube FDA listed
Cortizone 10 Itch Relief Massaging Rollerball 1 g/100g 41167-0338-00 Chattem, 1 bottle FDA listed
anti itch 1 g/100g 41250-0369-16 Meijer 1 tube Discontinued
Publix Hydro 1 g/100g 41415-0047-75 Publix 1 tube FDA listed
Publix hydro plus 1 g/100g 41415-0048-75 Publix 1 tube FDA listed
Hydrocortisone Cream 1% 1 g/100g 41415-0330-02 Publix 1 tube FDA listed
careone anti itch 1 g/100g 41520-0033-64 American 1 tube FDA listed
Care One hydrocortisone maximum strength 1 g/100g 41520-0319-64 American 1 tube FDA listed
Anti Itch 1 g/100g 42507-0319-64 HyVee 1 tube FDA listed
anti itch 1 g/100g 42507-0973-64 HyVee 1 tube FDA listed
Xpect Hydrocortisone .01 g/g 42961-0237-02 Cintas 10 packets FDA listed
Hydrocortisone 10 mg/g 43473-0049-01 Nantong 9 g FDA listed
Aosi Healthcare 1 g/100g 43473-0054-01 Nantong 9 g FDA listed
health beyond 1 g/100g 43473-0092-01 Nantong 9 g FDA listed
SurviveX Hydrocortisone Cream 10 mg/g 43473-0313-01 Nantong 9 g FDA listed
Avedana Hydrocortisone Cream with Aloe 10.2 mg/g 43749-0620-02 Unipack 1 tube FDA listed
Kera Hc 1 g/100g 44577-0623-02 Clinical 56 g FDA listed
Vanicream HC Anti-Itch 1.12 g/100g 45334-0327-02 Pharmaceutical 1 tube FDA listed
Hydrocortisone with Aloe 1 g/100g 46122-0822-36 AMERISOURCE 1 tube FDA listed
Medi-First Hydrocortisone 1% 10 mg/g 47682-0207-12 Unifirst 10 packets FDA listed
Hydrocortisone 10 mg/g 47682-0211-12 Unifirst 10 pouches FDA listed
Hydrocortisone 10 mg/g 47682-0397-35 Unifirst 144 packets FDA listed
Green Guard Hydrocortisone 1% 10 mg/g 47682-0398-73 Unifirst 25 packets FDA listed
Medi-First 1% Hydrocortisone 10 mg/g 47682-0923-73 Unifirst 25 packets FDA listed
Hydrocortisone 10 mg/g 47682-0933-73 Unifirst 25 pouches FDA listed
Medi-First Hydrocortisone 1% 10 mg/g 47682-0980-35 Unifirst 144 packets FDA listed
Medi-First Plus Hydrocortisone 1% 10 mg/g 47682-0981-73 Unifirst 25 packets FDA listed
equate hydrocortisone 1 g/100g 49035-0707-16 Wal-Mart 1 tube Discontinued
Hydrocortisone anti-itch plus 10 mg/g 49035-0732-02 Wal-Mart 1 tube FDA listed
Equate Hydrocortisone Intensive Healing Formula 1 g/100g 49035-0973-27 Wal-Mart 1 tube FDA listed
Unishield 1% 1 g/100g 49314-0005-01 Unishield 25 packets FDA listed
CeraVe Developed with Dermatologists Anti Itch 10 mg/g 49967-0108-01 L'Oreal 1 tube FDA listed
Rugby Hydrocortisone With Aloe .01 g/g 50090-5470-00 A-S 1 tube FDA listed
good sense anti itch 1 g/100g 50090-7255-00 A-S 1 tube FDA listed
Hydrocortisone with Aloe 1 g/100g 50090-7428-00 A-S 1 tube FDA listed
Live Better Hydrocortisone with Aloe 1 g/100g 51143-0059-02 The 1 tube FDA listed
Hydrocortisone 10 mg/g 51316-0227-00 CVS 1 tube FDA listed
Hydrocortisone 10 mg/g 51316-0230-00 CVS 1 tube FDA listed
Aloe Cort .57 g/57g 51326-0108-57 Topiderm, 57 g FDA listed
CAREALL Hydrocortisone Maximum Strength 1 g/g 51824-0050-01 New 28 g FDA listed
CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0097-01 New 28 g FDA listed
CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0098-14 New 144 packets FDA listed
CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0197-02 New 72 tubes FDA listed
Hydrocortisone Anti-Itch .01 g/g 52000-0022-37 Universal 1 tube Discontinued
Anti-itch 10 mg/g 53329-0091-01 Medline 1 tube FDA listed
Discount Drug Mart Anti-itch 1 g/100g 53943-0269-01 DISCOUNT 1 tube FDA listed
DermaCort Anti-itch 10 mg/g 54473-0117-28 Melaleuca, 28 g FDA listed
Exchange Select Hydrocortisone 1 g/100g 55301-0201-64 Army 1 tube FDA listed
Freds Hydrocortisone with Aloe 1 g/100g 55315-0181-56 FRED'S, 1 tube FDA listed
Freds Hydrocortisone Plus 12 Moisturizers 1 g/100g 55315-0182-56 FRED'S, 1 tube FDA listed
Family Wellness Max Strength 1 Hydrocortisone Cream 10 mg/g 55319-0982-00 Family 1 tube FDA listed
Thera Plus 1 g/100g 55621-0001-01 Zhejiang 28 g FDA listed
Family Wellness 1 g/100g 55621-0008-01 Zhejiang 28 g FDA listed
Assured 1 g/100g 55621-0018-28 Zhejiang 1 tube FDA listed
ProCure Hydrocortisone 1% 1 g/100g 55681-0018-01 Twin 28.3 g FDA listed
ProCure Hydrocortisone 1% 1 g/100g 55681-0019-14 Twin 144 packets FDA listed
Rapidol 1 g/100g 55758-0420-03 Pharmadel 1 tube FDA listed
rexall anti itch maximum strength relief 1 g/100g 55910-0225-64 Dolgencorp, 1 tube FDA listed
DG Health Hydrocortisone Maximum Strength 1 g/100g 55910-0319-64 Dolgencorp 1 tube FDA listed
DG health hydrocortisone 1 g/100g 55910-0504-16 Dolgencorp, 1 tube FDA listed
Hydrocortisone 1% 1 g/100g 57896-0146-14 Geri-Care 144 packets FDA listed
Hydrocortisone 1% 1 g/100g 58228-2045-02 ProStat 25 packets FDA listed
PS-2896 Hydrocortisone Cream 1%, 0.9g 1 g/100g 58228-2896-01 ProStat 2000 packets FDA listed
Hydrocortisone Cream 1% 1 g/100g 58228-6245-01 Front 25 packets FDA listed
Hydrocortisone 1% 1 g/100g 58228-7020-01 ProStat 2000 packets FDA listed
Hydrocortisone 1% 1 g/100g 58228-7030-01 ProStat 25 packets FDA listed
Audiologist Anti-itch 1 g/100g 59256-0004-01 OAKTREE 1 tube FDA listed
Quadrydern 10 mg/g 59428-0403-57 Productos 1 tube FDA listed
CVS Cortisone 1 g/100g 59779-0099-02 CVS 1 tube FDA listed
Hydrocortisone 10 mg/g 61010-5800-02 Safetec 144 pouches FDA listed
TrueLipids 1% Hydrocortisone Barrier Cream 1 g/100g 61387-0252-01 Claridei 50 g FDA listed
Hydrocortisone with Aloe 1 g/100g 63187-0504-01 Proficient 1 tube FDA listed
Hydrocortisone 10 mg/g 63629-1951-01 Bryant 1 tube AT FDA listed
kirkland signature hydrocortisone plus maximum strength 1 g/100g 63981-0973-34 Costco 4 tubes FDA listed
Proctocort 10 mg/g 65649-0501-30 Salix 1 tube AT Discontinued
Gelmicin Hydrocortisone with Aloe 1 g/100g 65923-0035-40 United 1 tube FDA listed
Family Care Anti-Itch 1 g/100g 65923-0494-14 United 1 tube FDA listed
Family Care Anti-Itch 1 g/100g 65923-0925-14 United 1 tube FDA listed
WINCO Hydrocortisone 10 mg/g 67091-0055-28 WinCo 1 tube FDA listed
Winco Maximum Strength Hydrocortisone 10 mg/g 67091-0197-28 WINCO 1 tube FDA listed
WinCo Foods Hydrocortisone Cream Intensive Healing 10 mg/g 67091-0419-28 WINCO 1 tube FDA listed
Natureplex Hydrocortisone Hydro .01 g/g 67234-0010-01 Natureplex, 28 g FDA listed
Hydrocortisone 1 g/100g 67777-0004-01 Dynarex 1 tube FDA listed
Hydrocortisone 1 g/100g 68016-0149-01 Pharmacy 1 tube FDA listed
Hydrocortisone 1 g/100g 68016-0529-01 Pharmacy 1 tube FDA listed
hydrocortisone 1 g/100g 68071-5205-01 NuCare 28 g FDA listed
Hydrocortisone with Aloe 1 g/100g 68071-5305-01 NuCare 1 tube FDA listed
members mark hydrocortisone 1 g/100g 68196-0973-34 Sam's 4 tubes FDA listed
berkley and jensen anti itch 1 g/100g 68391-0100-16 BJWC 2 tubes FDA listed
CliniCalm 1 g/100g 68726-0504-01 CP 7 g FDA listed
Hydrocortisone 1% 1 g/100g 68788-4109-02 Preferred 1 tube FDA listed
good sense anti itch 1 g/100g 68788-4122-02 Preferred 1 tube FDA listed
hydrocortisone 1 g/100g 68788-8078-02 Preferred 1 tube FDA listed
Hydrocortisone 1% with healing aloe 1 g/100g 69396-0005-05 Trifecta 1 tube FDA listed
Hydrocortisone Cream 1 g/100g 69396-0028-01 Trifecta 1 tube FDA listed
Hydrocortisone 1% 1 g/100g 69396-0050-01 Trifecta 1 tube FDA listed
Hydrocortisone 1% 1 g/100g 69396-0055-01 Trifecta 1 tube FDA listed
Itch Relief 1 g/100g 69396-0057-01 Trifecta 1 tube FDA listed
Hydrocortisone 1% 1 g/100g 69396-0081-01 Trifecta 1 tube FDA listed
Hydrocortisone Cream 1 g/100g 69396-0096-16 Trifecta 454 g FDA listed
Hydrocortisone 1% 1 g/100g 69396-0118-09 Trifecta 144 packets FDA listed
Hydrocortisone 1% 1 g/100g 69396-0129-01 Trifecta 1 tube FDA listed
Hydrocortisone Cream 1 g/100g 69396-0147-01 Trifecta 1 tube FDA listed
Alumier MD Intensive Recovery 10 mg/mL 69473-0017-01 Alumier 1 tube FDA listed
Alumier MD Post Procedure Kit with Hydrocortisone 69473-0020-01 Alumier 1 kit FDA listed
Family Wellness 1 g/100g 69571-0009-01 FRONT 1 tube FDA listed
Barmicil Plus 10 mg/g 69729-0103-11 OPMX 28 g FDA listed
Quatriderm Anti-itch 1 g/100g 69729-0269-53 OPMX 1 tube FDA listed
Barmicil Anti-itch 1 g/100g 69729-0301-51 OPMX 1 tube FDA listed
CVS Health Hydrocortisone Anti Itch 10 mg/g 69842-0155-10 CVS 24 packets Discontinued
CVS Anti itch 1 g/100g 69842-0292-01 CVS 1 tube FDA listed
Maximum Strength Cortisone Cream with Aloe 1 g/100g 69842-0630-03 CVS 1 tube FDA listed
Aveeno Hydrocortisone ANTI-ITCH 10 mg/g 69968-0511-01 Kenvue 1 tube FDA listed
Aveeno 1% Hydrocortisone Anti-Itch Cream 10 mg/g 69968-0888-01 Kenvue 1 tube FDA listed
Ana Cool Rapid Soothing Cooling Formula 10 mg/g 70288-0714-01 Ana-Cool, 1 bottle FDA listed
Post-Treatment Repair Cream 1 g/100mL 70484-0007-02 Vi 22 ml FDA listed
Caring Mills Hydrocortisone 1 g/100g 71101-0021-01 Veridian 1 tube FDA listed
TheraCare Hydrocortisone Cream 10 mg/g 71101-0220-01 Veridian 1 tube FDA listed
hydrocortisone 1 g/100g 71205-0571-01 Proficient 1 tube FDA listed
Hydrocortisone 1 mg/100g 71399-0180-01 AKRON 454 g FDA listed
American Safety and First Aid 10 mg/g 71927-0031-02 Orazen 25 pouches FDA listed
Medi-First 10 mg/g 71927-0032-02 Orazen 25 pouches FDA listed
Medi First Plus 10 mg/g 71927-0033-02 Orazen 25 pouches FDA listed
Hydrocortisone 10 mg/g 72162-1763-02 Bryant 1 tube AT FDA listed
hydrocortisone 1 g/100g 72162-2283-02 Bryant 1 tube FDA listed
Hydrocortisone 10 mg/g 72189-0209-28 DIRECT 28.4 g AT FDA listed
Basic Care Hydrocortisone 1 g/100g 72288-0369-64 Amazon.com 1 tube FDA listed
basic care hydrocortisone 1 g/100g 72288-0973-16 Amazon.com 1 tube FDA listed
Hydrocortisone 10 mg/g 73141-0622-28 A2A 1 tube FDA listed
Crane Safety Hydrocortisone 10 mg/g 73408-0933-73 Crane 25 packets FDA listed
Thompson Hydrocortisone 1% 10 mg/g 73408-0937-73 Thompson 25 packets FDA listed
Thompson Hydrocortisone 1% 10 mg/g 73408-0981-73 Thompson 25 packets FDA listed
Gembooxt ECZEMA RELIEF Cream .01 g/g 76986-0019-01 Guangdong 2 bottles FDA listed
Meijer Hydrocortsione Cream 1 g/100g 79481-0018-01 Meijer 1 tube FDA listed
anti itch 1 g/100g 79481-0319-00 Meijer, 1 tube FDA listed
anti itch 1 g/100g 79481-0973-00 Meijer, 1 tube FDA listed
Equate Hydrocortisone Topical .01 g/g 79903-0091-01 WalMart 1 tube FDA listed
Equate Hydrocortisone 10 mg/g 79903-0092-01 WalMart 1 tube FDA listed
Hydrocortisone 10 mg/g 80489-0001-01 OL 1 tube FDA listed
Thera plus Anti-itch with aloe Hydrocortisone 10 mg/g 80684-0038-01 Fourstar 1 tube FDA listed
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0145-00 Fourstar 42.5 g FDA listed
Thera Plus Eczema Hydrocortisone Anti Itch 10 mg/g 80684-0146-00 Fourstar 28 g FDA listed
Thera Plus Hydrocortisone Maximum Strength 10 mg/g 80684-0151-00 FOURSTAR 42.5 g FDA listed
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0197-00 Fourstar 6 packets FDA listed
ZCort Ultra 10 mg/g 81335-0532-15 RxDino, 15 g FDA listed
THERAPLEX AIM Anti-Itch Moisturizing 10 mg/g 82280-0478-02 THERAPLEX, 56.7 g FDA listed
Westlake Anti-itch 1 g/100g 82895-0716-30 Westlake 1 tube FDA listed
Hydrocortisone 10 mg/g 82942-1003-01 J&A 9 g FDA listed
Anti-Itch with Aloe 1 g/100g 83324-0046-01 Chain 1 tube FDA listed
Quality Choice 10 mg/g 83324-0297-01 Chain 1 tube FDA listed
Hydrocortisone 1% 1 g/100g 83324-0329-01 Chain 1 tube FDA listed
Bloop Itch Soothing Topical 1 g/100g 83838-0415-01 Three 1 tube FDA listed
Itch and Rash Cream 10 mg/g 84269-4506-01 Wildman 25 packets FDA listed
Hydrocortisone 10 mg/g 84387-0005-01 ALLIED 28.4 g FDA listed
Hydrocortisone 1 g/100g 84722-3031-01 VIVE 4 g FDA listed
Serynth Eczema Relief 1 g/100g 85248-0104-01 Jiangxi 20 g FDA listed
DERMFREE Anti-itch 1 g/100g 85248-0126-01 Jiangxi 42.5 g FDA listed
NATUHEAL RELIEF Cream FOR ECZEMA 1 g/100g 85248-0157-01 Jiangxi 20 g FDA listed
Drmitsui Eczema Relief 1 g/100g 85248-0181-01 Jiangxi 20 g FDA listed
Hydrocortisone 1 g/100g 85402-0001-01 Medrock 1 tube FDA listed
hydrocortisone 1 g/100g 85766-0151-28 Sportpharm 1 tube FDA listed
Hydrocortisone 10 mg/g 85766-0166-10 Sportpharm 10 pouches FDA listed
Proheal Hydrocortisone 1% Maximum Strength Plus Aloe 1 g/100g 86173-0005-04 Click 113 g FDA listed
zourunan Relieve itching cream ANTIFUNGAL 1 g/100g 87083-0003-01 Guchutang 20 g FDA listed
Absolut Skin Corticosoothe Anti-Itch 10 mg/mL 87184-0899-00 Absolut 1 tube FDA listed
Hydrocortisone with Aloe 1 g/100g 87236-0003-01 Aldermed 1 tube FDA listed
Hydrocortisone 1 g/100g 87236-0004-09 Aldermed 144 packets FDA listed
DERMFREE Anti-itch Cream 1 g/100g 87686-0001-01 Jiangxi 42.5 g FDA listed
SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g 70288-0173-00 Ana-Cool, 56.7 g FDA listed
Cortizone 10 Cooling Relief 10 mg/g 41167-0036-00 Chattem, 1 tube FDA listed
Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 ViaDerma 1 bottle FDA listed
Cortizone 10 Intensive Healing for Eczema 10 mg/g 41167-0331-00 Chattem, 1 tube FDA listed
Preparation H Soothing Relief Anti-Itch 10 mg/g 00573-0552-11 Haleon 1 tube FDA listed
Preparation H Hydrocortisone 10 mg/g 00573-2830-10 Haleon 1 tube FDA listed
FifthPulse Hydrocortisone 10 mg/g 87525-0003-01 WeCare 1 tube 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

🏛️
1976
On the market since
Apr 1976
📍
2026
Currently FDA-listed
50 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.

🗺️ 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 00168-0015-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.4K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$113.8K
Avg / prescription
$33.31
Avg / unit
$0.0816
Latest quarter Q4 2025
817Rx
Medicaid pays / g
$0.0816
gross reimbursed
vs
NADAC / g
$0.1128
acquisition cost
=
Spread
−$0.0312
-28% 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
66% FFS 34% MCO
Fee-for-service · 2,248 Rx Managed care · 1,170 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: 8,647 units · 151 per 100k residents MN Wisconsin: 17,861 units · 302 per 100k residents WI Michigan: 21,629 units · 215 per 100k residents MI New York: 100,435 units · 513 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 6,439 units · 202 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 31,007 units · 247 per 100k residents IL Indiana: 16,216 units · 236 per 100k residents IN Ohio: 52,164 units · 443 per 100k residents OH Pennsylvania: 24,115 units · 186 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 89,362 units · 1,276 per 100k residents MA California: 282,384 units · 725 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 465,774 units · 7,517 per 100k residents MO Kentucky: 51,087 units · 1,129 per 100k residents KY West Virginia: no data reported WV Virginia: 21,447 units · 246 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 26,693 units · 375 per 100k residents TN North Carolina: 18,607 units · 172 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 2,849 units · 62.3 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 112,002 units · 367 per 100k residents TX Florida: 47,202 units · 209 per 100k residents FL
Units reimbursed · per 100k residents
62.37,517
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 7,517 /100k
2 Massachusetts 1,276 /100k
3 Kentucky 1,129 /100k
4 California 725 /100k
5 New York 513 /100k
6 Ohio 443 /100k
7 Tennessee 375 /100k
8 Texas 367 /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 tube00168-0015-31 108,784 Rx · $1,017,016
453 gs this page00168-0015-16 3,418 Rx · $113,840
Drug total (last 4 qtrs): 112,202 Rx · 4,946,781 units · $1,130,856 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydrocortisone — the ingredient across all brands.

Top reported reactions

Fatigue12,539
Pain10,830
Arthralgia9,700
Nausea9,667
Diarrhoea9,066
Rash9,002
Condition Aggravated8,913

Age at onset

Neonate382
Infant378
Child1,276
Adolescent928
Adult13,999
Elderly6,577

Reporter sex

123,954 reports

Serious outcomes

Hospitalization47,559
Life-threatening12,667
Disabling10,100
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 9,888 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00168-0015-16 You're viewing this 453.6 g in 1 JAR (0168-0015-16) $0.1128 / g $51.17 1976-04-30 Active
00168-0015-31 1 TUBE in 1 CARTON (0168-0015-31) / 28.35 g in 1 TUBE $0.1118 / g $3.17 1976-04-30 Active

This pack accounts for about 3.0% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00168-0015-16?
NDC 00168-0015-16 contains 453.6 g — 453.6 g in 1 jar.
What is the difference between NDC 00168-0015-16 and NDC 00168-0015-31?
Both are hydrocortisone 10 mg/g Cream — the drug itself is identical. NDC 00168-0015-16 is the 453.6 g package, while NDC 00168-0015-31 is the 1 tube package. Per-g NADAC also differs: $0.1128 here vs $0.1118 for the 1 tube pack.
What NDC number is used to bill for this package of hydrocortisone 10 mg/g Cream?
Bill NDC 00168-0015-16 — the 11-digit billing format is 00168001516. 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.

📄 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 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 two or three 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 53 words

HOW SUPPLIED Hydrocortisone Cream USP, 1%, a white cream, is supplied as follows: NDC 0168-0015-31 28.35 g (1 Oz) Tubes NDC 0168-0015-16 453.6 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 60 words

DESCRIPTION Hydrocortisone Cream 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 glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid, and purified water. Structural Formula

💬 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.