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Proctocort HYDROCORTISONE 10 mg/g Cream, 1 tube — NDC 65649-0501-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Proctocort HYDROCORTISONE 10 mg/g Cream, 1 tube — NDC 65649-501-30 (Billing 65649-0501-30)

by Salix Pharmaceuticals, Inc · 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE

This is a package of 1 tube of Proctocort HYDROCORTISONE 10 mg/g Cream from Salix Pharmaceuticals, Inc, no longer marketed (first marketed Jun 2004), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 65649-0501-30
🏷️ FDA NDC (as labeled) 65649-501-30 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65649-501-30
Product NDC 65649-501
11-digit billing NDC 65649050130
NCPDP billing unit GM — per gram (weight)
RxCUI 106258, 1865144
UNII WI4X0X7BPJ
Application # ANDA080706
SPL Set ID 8c318d15-30e4-4395-9aa9-4157d349fe70
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2004-06-01
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 89100010003705
GPI class Proctocort
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 PROCTOCORT 1% CREAM
FDB brand name Proctocort
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007544
  • GCN: 30942
  • GPI-14 (Medi-Span): 89100010003705
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 106258
Why two NDCs? The FDA registers this code as 65649-501-30 — a 5-3-2 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 product segment → 65649-0501-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

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

Clinical

Label name PROCTOCORT 1% CREAM Ingredient Hydrocortisone
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

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

🧪 Full Hydrocortisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65649-0501-30 You're viewing this Main listing 1 TUBE in 1 CARTON / 28.35 g in 1 TUBE 2004-06-01 — Inactivated by FDA

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 $0.059 — Availability likely —
Hydrocortisone Cream with Aloe 1 g/100g 70000-0662-01 Cardinal 1 tube $0.059 — 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 $0.061 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers 1 g/100g 24385-0021-03 AmerisourceBergen 1 tube $0.061 — Availability likely —
hydrocortisone 1 g/100g 45802-0438-03 Padagis 1 tube $0.061 — Availability likely —
Hydrocortisone Plus 12 Moisturizers 1 g/100g 51672-2063-02 Sun 1 tube $0.061 — Availability likely —
Hydrocortisone Acetate Antipruritic (Anti-Itch) 1 g/100g 51672-2069-02 Sun 1 tube $0.061 — Availability likely —
Hydrocortisone 1 g/100g 68001-0476-46 BluePoint 1 tube $0.061 — Availability likely —
Hydrocortisone 1 g/100g 70000-0485-01 Cardinal 1 tube $0.061 — 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 $0.072 — Availability likely —
Hydrocortisone with Aloe 1 g/100g 70677-1216-01 STRATEGIC 1 tube $0.072 — Availability likely —
Sunmark Hydrocortisone with Aloe Maximum Strength 1 g/100g 49348-0521-72 Strategic 1 tube $0.093 — Discontinued —
hydrocortisone 10 mg/g 00168-0015-16 E. 453.6 g $0.109 AT Availability likely —
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely —
Hydrocortisone with Aloe 1 g/100g 51672-2013-01 Sun 1 tube $0.135 — Availability likely —
Hydrocortisone with Aloe 1 g/100g 51672-5330-01 Sun 1 tube $0.135 — Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.138 AT Availability likely —
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.600 AT Availability likely —
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/gthis 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

🏛️
2004
On the market since
Jun 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerSalix Pharmaceuticals, Inc
Application holderCROWN LABORATORIES INC
FDA applicationANDA080706 (ANDA)
Labeler code65649
First marketedJun 2004
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

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

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

⏱️ Dosage and Administration 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 76 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 Salix Pharmaceuticals at 1-800-321-4576 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 systemic 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 61 words ▾

HOW SUPPLIED Proctocort ® (Hydrocortisone Cream USP), 1% is supplied in: 1 ounce (28.4 grams) tube NDC 65649-501-30 Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA PROCTOCORT ® is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2019 Salix Pharmaceuticals, Inc. or its affiliates PRINTED IN USA Revised: Oct. 2019 P8800.04 9521701

📦 Storage and Handling 12 words ▾

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

📋 Description 90 words ▾

DESCRIPTION The topical corticosteroids constitute a class of primary 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 Proctocort ® (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. formula.jpg

💬 Information for Patients 127 words ▾

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

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

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

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

⚠️ Precautions ~1 min read ▾

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

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

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

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

🍼 Nursing Mothers 58 words ▾

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

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

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

📄 Package Label / Principal Display Panel 31 words ▾

NDC 65649-501-30 Rx only PROCTOCORT® Hydrocortisone Cream USP, 1% 1 oz (28.4 grams) WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. Salix PHARMACEUTICALS carton.jpg

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Proctocort — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Proctocort. 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
$7.8K
Claims incl. refills
19
Beneficiaries
17
Spend / beneficiary
$456.17
Spend / claim
$408.15
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 Proctocort (this brand).

Top reported reactions

Fatigue1,973
Pain1,967
Abdominal Discomfort1,965
Systemic Lupus Erythematosus1,927
Rash1,914
Alopecia1,893
Rheumatoid Arthritis1,826

Age at onset

Neonate19
Infant5
Child32
Adolescent31
Adult912
Elderly173

Reporter sex

5,370 reports
Male · 23%
Female · 77%
Unknown · 0%

Serious outcomes

Hospitalization2,509
Disabling2,185
Life-threatening1,823
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 900 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Salix Pharmaceuticals, Inc 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.
← 65649-0411-12 · Salix 65649-0511-12 · Salix →
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.