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Hydrocortisone 10 mg/g Cream, 1 tube — NDC 63629-1951-01 package photo

Hydrocortisone 10 mg/g Cream, 1 tube

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON (63629-1951-1) / 28.4 g in 1 TUBE
NDC 63629-1951-01
🏷️ FDA NDC (as labeled) 63629-1951-1 billing pads the package segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63629-1951-1
Product NDC 63629-1951
11-digit billing NDC 63629195101
NCPDP billing unit GM — per gram (weight)
RxCUI 106258
UNII WI4X0X7BPJ
Application # ANDA080706
SPL Set ID 7f262fa3-4d2a-43f2-a4a7-f49f6034cf50
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 2016-04-01
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
GPI-14 89100010003705
GPI class Hydrocortisone (Perianal)
GCN Seq No 006859
GCN 28851
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 63629-1951-1 — a 5-4-1 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 package segment → 63629-1951-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderCROWN LABORATORIES INC
FDA applicationANDA080706 (ANDA)
Labeler code63629
First marketedApr 2016
Product typeHuman Prescription Drug
Portfolio4,434 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.

🧪 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.

🧪 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.

💲 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 $11.75 / 28.4 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Hydrocortisone With Aloe .01 g/g 70000-0543-01 LEADER 1 tube $0.056 — FDA listed —
Hydrocortisone Cream with Aloe 1 g/100g 00536-1407-95 Rugby 1 tube $0.058 — Availability likely —
Hydrocortisone Cream with Aloe 1 g/100g 70000-0662-01 Cardinal 1 tube $0.058 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone with Aloe 1 g/100g 24385-0274-03 AmerisourceBergen 1 tube $0.059 — Availability likely —
good sense anti itch 1 g/100g 00113-0541-64 L. 1 tube $0.062 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers 1 g/100g 24385-0021-03 AmerisourceBergen 1 tube $0.062 — Availability likely —
hydrocortisone 1 g/100g 45802-0438-03 Padagis 1 tube $0.062 — Availability likely —
Hydrocortisone Plus 12 Moisturizers 1 g/100g 51672-2063-02 Sun 1 tube $0.062 — Availability likely —
Hydrocortisone Acetate Antipruritic (Anti-Itch) 1 g/100g 51672-2069-02 Sun 1 tube $0.062 — Availability likely —
Hydrocortisone 1 g/100g 68001-0476-46 BluePoint 1 tube $0.062 — Availability likely —
Hydrocortisone 1 g/100g 70000-0485-01 Cardinal 1 tube $0.062 — Availability likely —
Hydrocortisone 1% 1 g/100g 83324-0047-01 Chain 1 tube $0.062 — Availability likely —
Itch Relief 1 g/100g 70677-1215-01 STRATEGIC 1 tube $0.070 — Availability likely —
Hydrocortisone with Aloe 1 g/100g 70677-1216-01 STRATEGIC 1 tube $0.070 — Availability likely —
Sunmark Hydrocortisone with Aloe Maximum Strength 1 g/100g 49348-0521-72 Strategic 1 tube $0.093 — Discontinued —
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely —
hydrocortisone 10 mg/g 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 —
Hydrocortisone with Aloe 1 g/100g 51672-5330-01 Sun 1 tube $0.130 — Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.134 AT Availability likely —
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.569 AT Availability likely —
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/gthis 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

🏛️
2016
On the market since
Apr 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.

📊 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 Marketing startStatus
63629-1951-01 You're viewing this 1 TUBE in 1 CARTON (63629-1951-1) / 28.4 g in 1 TUBE 2021-03-01 Active

🧭 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 FDA registers it as 63629-1951-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63629-1951-01, written without dashes as 63629195101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63629-1951-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1951) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.

📄 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
🎯 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 55 words ▾

DOSAGE AND ADMINISTRATION Apply 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 Topical 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 ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/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 118 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.

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

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology 192 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. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

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

(See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 24 words ▾

HOW SUPPLIED Hydrocortisone Cream USP, 1% is supplied in: 1 oz (28.4 grams) tube NDC 63629-1951-1 Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📦 Storage and Handling 16 words ▾

PACKAGING AND STORAGE Store at 20° to 25°C (68° to 77°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. structure

💬 Information for Patients 122 words ▾

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

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing.

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 ↗
← 63629-1946-01 · Bryant 63629-1952-01 · Bryant →
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.