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FifthPulse Hydrocortisone 4oz 1 g/100g Ointment, 113.4 g — NDC 69571-0015-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FifthPulse Hydrocortisone 4oz 1 g/100g Ointment, 113.4 g — NDC 69571-015-01 (Billing 69571-0015-01)

by Front Pharmaceutical PLC · 113.4 g in 1 TUBE

This is a package of 113.4 g of FifthPulse Hydrocortisone 4oz 1 g/100g Ointment from Front Pharmaceutical PLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 69571-0015-01
🏷️ FDA NDC (as labeled) 69571-015-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69571-015-01
Product NDC 69571-015
11-digit billing NDC 69571001501
UNII WI4X0X7BPJ
Application # M004
SPL Set ID 39fb29c8-6a28-e87e-e063-6294a90a78da
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-16
Route TOPICAL
Dosage form OINTMENT
Substance HYDROCORTISONE
Why two NDCs? The FDA registers this code as 69571-015-01 — 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 → 69571-0015-01. 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.

Clinical

📗 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
69571-0015-01 You're viewing this Main listing 113.4 g in 1 TUBE 2025-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 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 —
good sense anti itch 1 g/100g 00113-0541-64 L. 1 tube $0.061 — Availability likely —
Hydrocortisone Plus 12 Moisturizers 1 g/100g 51672-2063-02 Sun 1 tube $0.061 — Availability likely —
Hydrocortisone 1% 1 g/100g 83324-0047-01 Chain 1 tube $0.062 — Availability likely —
hydrocortisone 1 g/100g 45802-0276-03 Padagis 1 tube $0.070 — Availability likely —
Hydrocortisone with Aloe 1 g/100g 70677-1216-01 STRATEGIC 1 tube $0.072 — Availability likely —
Itch Relief 1 g/100g 70677-1215-01 STRATEGIC 1 tube $0.072 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone 1 g/100g 24385-0276-03 AmerisourceBergen 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 70677-1214-01 STRATEGIC 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 51672-2018-02 Sun 1 tube $0.077 — Availability likely —
sunmark Hydrocortisone 1 g/100g 49348-0522-72 Strategic 1 tube $0.077 — Availability likely —
Sunmark Hydrocortisone with Aloe Maximum Strength 1 g/100g 49348-0521-72 Strategic 1 tube $0.093 — Discontinued —
Hydrocortisone with Aloe 1 g/100g 51672-2013-01 Sun 1 tube $0.135 — Availability likely —
Discount Drug Mart Anti-itch 1 g/100g 53943-0269-01 DISCOUNT 1 tube — — 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 —
Rite Aid Anti-itch 1 g/100g 11822-3130-01 Rite 1 tube — — FDA listed —
Kera Hc 1 g/100g 44577-0623-02 Clinical 56 g — — 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 —
Quatriderm Anti-itch 1 g/100g 69729-0269-53 OPMX 1 tube — — FDA listed —
Westlake Anti-itch 1 g/100g 82895-0716-30 Westlake 1 tube — — FDA listed —
Bloop Itch Soothing Topical 1 g/100g 83838-0415-01 Three 1 tube — — FDA listed —
MediBalm 1 g/100g 85529-0204-01 BalmRx, 1 jar — — FDA listed —
hydrocortisone 1 g/100g 85766-0151-28 Sportpharm 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 —
Cortizone 10 Water Resistant 1 g/100g 41167-0344-00 Chattem, 1 tube — — FDA listed —
Care One hydrocortisone maximum strength 1 g/100g 41520-0319-64 American 1 tube — — FDA listed —
hydrocortisone 1 g/100g 50090-6526-00 A-S 1 tube — — 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 —
Hydrocortisone 1 g/100g 69396-0149-01 TRIFECTA 1 tube — — FDA listed —
Aquaphor Itch Relief 1 g/100g 10356-0120-04 Beiersdorf 28 g — — FDA listed —
Hydrocortisone Plus 12 Moisturizers 1 g/100g 11673-0399-02 TARGET 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 —
TopCare Hydrocortisone 1 g/100g 36800-0018-02 Topco 1 tube — — FDA listed —
Topcare Hydrocortisone 1 g/100g 36800-0471-64 Topco 1 tube — — FDA listed —
Shopko Hydrocortisone Maximum Strength 1 g/100g 37012-0059-02 Shopko 1 tube — — FDA listed —
equaline anti itch maximum strength 1 g/100g 41163-0369-64 United 1 tube — — FDA listed —
Equate Hydrocortisone Intensive Healing Formula 1 g/100g 49035-0973-27 Wal-Mart 1 tube — — FDA listed —
CliniCalm 1 g/100g 68726-0504-01 CP 7 g — — FDA listed —
basic care hydrocortisone 1 g/100g 72288-0973-16 Amazon.com 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 84722-3031-01 VIVE 4 g — — FDA listed —
Hydrocortisone Intensive Healing Formula 1 g/100g 11673-0398-02 TARGET 1 tube — — FDA listed —
up and up hydrocortisone anti itch 1 g/100g 11673-0842-00 Target 2 tubes — — Discontinued —
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 —
Cortizone 10 Soothing Aloe Itch Relief 1 g/100g 41167-0024-00 Chattem, 1 tube — — FDA listed —
kirkland signature hydrocortisone plus maximum strength 1 g/100g 63981-0973-34 Costco 4 tubes — — FDA listed —
Family Care Anti-Itch 1 g/100g 65923-0925-14 United 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 68788-4109-02 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 1% 1 g/100g 69396-0055-01 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 —
CVS Anti itch 1 g/100g 69842-0292-01 CVS 1 tube — — FDA listed —
hydrocortisone 1 g/100g 72162-2283-02 Bryant 1 tube — — FDA listed —
anti itch 1 g/100g 79481-0471-00 Meijer, 1 tube — — FDA listed —
anti itch 1 g/100g 79481-0973-00 Meijer, 1 tube — — FDA listed —
ElixirCortiRelief 1 g/100g 84546-0005-01 ELIXIR 1 tube — — FDA listed —
hydrocortisone 1 g/100g 21130-0449-16 Safeway 1 tube — — FDA listed —
topcare hydrocortisone 1 g/100g 36800-0524-26 Topco 2 tubes — — FDA listed —
Topcare Hydrocortisone 1 g/100g 36800-0981-64 Topco 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 —
Publix Hydro 1 g/100g 41415-0047-75 Publix 1 tube — — FDA listed —
Live Better Hydrocortisone with Aloe 1 g/100g 51143-0059-02 The 1 tube — — FDA listed —
Family Care Anti-Itch 1 g/100g 65923-0494-14 United 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 69396-0017-05 Trifecta 1 tube — — FDA listed —
hydrocortisone 1 g/100g 71205-0571-01 Proficient 1 tube — — FDA listed —
basic care hydrocortisone 1 g/100g 72288-0878-25 Amazon.com 1 tube — — FDA listed —
anti itch 1 g/100g 79481-0319-00 Meijer, 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 21922-0096-04 Encube 1 tube — — FDA listed —
Good Sense Anti Itch 1 g/100g 00113-0471-64 L. 1 tube — — FDA listed —
hydrocortisone anti itch 1 g/100g 37808-0369-64 H 1 tube — — FDA listed —
equaline anti itch 1 g/100g 41163-0319-16 United 1 tube — — FDA listed —
careone anti itch 1 g/100g 41520-0033-64 American 1 tube — — FDA listed —
Aosi Healthcare 1 g/100g 43473-0054-01 Nantong 9 g — — FDA listed —
DG Health Hydrocortisone Maximum Strength 1 g/100g 55910-0319-64 Dolgencorp 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 58228-7020-01 ProStat 2000 packets — — FDA listed —
TrueLipids 1% Hydrocortisone Barrier Cream 1 g/100g 61387-0252-01 Claridei 50 g — — FDA listed —
Hydrocortisone 1 g/100g 63187-0543-01 Proficient 1 tube — — FDA listed —
Gelmicin Hydrocortisone with Aloe 1 g/100g 65923-0035-40 United 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 00404-0166-50 Henry 1 tube — — FDA listed —
Anti Itch 1 g/100g 21130-0433-64 Safeway 1 tube — — FDA listed —
Maximum Strength Hydrocortisone 1 g/100g 24286-1560-01 DLC 1 tube — — FDA listed —
hydrocortisone 1 1 g/100g 30142-0369-64 Kroger 1 tube — — FDA listed —
Freds Hydrocortisone Plus 12 Moisturizers 1 g/100g 55315-0182-56 FRED'S, 1 tube — — FDA listed —
dg health hydrocortisone 1 g/100g 55910-0646-25 Dolgencorp, 1 tube — — FDA listed —
CVS Cortisone 1 g/100g 59779-0099-02 CVS 1 tube — — FDA listed —
cortisone 1 g/100g 59779-0878-25 CVS 1 tube — — FDA listed —
Hydrocortisone with Aloe 1 g/100g 63187-0504-01 Proficient 1 tube — — FDA listed —
members mark hydrocortisone 1 g/100g 68196-0973-34 Sam's 4 tubes — — FDA listed —
FifthPulse Hydrocortisone 1oz 1 g/100g 69571-0014-01 Front 28.4 g — — FDA listed —
Barmicil Anti-itch 1 g/100g 69729-0301-51 OPMX 1 tube — — FDA listed —
Proheal Hydrocortisone 1% Maximum Strength Plus Aloe 1 g/100g 86173-0005-04 Click 113 g — — FDA listed —
signature care Hydrocortisone 1 g/100g 21130-0166-25 Safeway 1 tube — — FDA listed —
Signature Care Hydrocortisone 1 g/100g 21130-0395-16 Safeway 1 tube — — FDA listed —
Signature Care Hydrocortisone 1 g/100g 21130-0993-64 Safeway 1 tube — — FDA listed —
TopCare Hydrocortisone Intensive Healing Formula 1 g/100g 36800-0099-02 Topco 1 tube — — FDA listed —
Cortisone 10 Intensive Moisture Creme 1 g/100g 41167-0022-00 Chattem, 1 tube — — FDA listed —
Cortisone 10 Overnight Creme 1 g/100g 41167-0109-02 Chattem, 1 tube — — FDA listed —
good sense anti itch 1 g/100g 50090-7255-00 A-S 1 tube — — 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 —
berkley and jensen anti itch 1 g/100g 68391-0100-16 BJWC 2 tubes — — FDA listed —
Hydrocortisone 1 g/100g 00363-1973-16 Walgreen 1 tube — — FDA listed —
good sense anti itch 1 g/100g 68788-4122-02 Preferred 1 tube — — 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 —
Caring Mills Hydrocortisone 1 g/100g 71101-0021-01 Veridian 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 83324-0329-01 Chain 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 85402-0001-01 Medrock 1 tube — — FDA listed —
topcare hydrocortisone 1 g/100g 36800-0939-64 Topco 1 tube — — FDA listed —
Shopko Hydrocortisone 1 g/100g 37012-0018-02 Shopko 1 tube — — FDA listed —
Cortizone 10 Intensive Healing Itch Relief Cream 1 g/100g 41167-0023-00 Chattem, 1 tube — — FDA listed —
Cortizone 10 Itch Relief Massaging Rollerball 1 g/100g 41167-0338-00 Chattem, 1 bottle — — FDA listed —
Publix hydro plus 1 g/100g 41415-0048-75 Publix 1 tube — — FDA listed —
Exchange Select Hydrocortisone 1 g/100g 55301-0201-64 Army 1 tube — — FDA listed —
Monistat Complete Care Instant Itch Relief 1 g/100g 63736-0029-01 Insight 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 00363-1333-01 Walgreens 1 tube — — FDA listed —
Hydrocortisone Cream 1 g/100g 69396-0028-01 Trifecta 1 tube — — FDA listed —
Basic Care Hydrocortisone 1 g/100g 72288-0369-64 Amazon.com 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 30142-0411-16 Kroger 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 —
Cortizone 10 Feminine Itch Relief 1 g/100g 41167-0330-03 Chattem, 1 tube — — FDA listed —
anti itch 1 g/100g 41250-0369-16 Meijer 1 tube — — Discontinued —
equate hydrocortisone 1 g/100g 49035-0707-16 Wal-Mart 1 tube — — Discontinued —
DG health hydrocortisone 1 g/100g 55910-0504-16 Dolgencorp, 1 tube — — FDA listed —
FifthPulse Hydrocortisone 4oz 1 g/100gthis 69571-0015-01 Front 113.4 g — — 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 —
Hydrocortisone 1 g/100g 37808-0319-64 H 1 tube — — FDA listed —
hydrocortisone 1 g/100g 37808-0471-64 H 1 tube — — FDA listed —
hydrocortisone 1 g/100g 37808-0973-64 H 1 tube — — FDA listed —
equaline anti itch 1 g/100g 41163-0471-64 United 1 tube — — FDA listed —
Cortizone 10 Ultra Soothing Itch Relief 1 g/100g 41167-0029-00 Chattem, 1 tube — — FDA listed —
Cortizone 10 Cooling 1 g/100g 41167-0033-02 Chattem, 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 —
health beyond 1 g/100g 43473-0092-01 Nantong 9 g — — FDA listed —
Unishield 1% 1 g/100g 49314-0005-01 Unishield 25 packets — — FDA listed —
Hydrocortisone with Aloe 1 g/100g 50090-7428-00 A-S 1 tube — — FDA listed —
Freds Hydrocortisone with Aloe 1 g/100g 55315-0181-56 FRED'S, 1 tube — — FDA listed —
ProCure Hydrocortisone 1% 1 g/100g 55681-0018-01 Twin 28.3 g — — FDA listed —
rexall anti itch maximum strength relief 1 g/100g 55910-0225-64 Dolgencorp, 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 57896-0146-14 Geri-Care 144 packets — — FDA listed —
hydrocortisone 1 g/100g 68071-5205-01 NuCare 28 g — — FDA listed —
Hydrocortisone 1 g/100g 69396-0003-20 TRIFECTA 1 tube — — FDA listed —
Hydrocortisone 1% 1 g/100g 69396-0050-01 Trifecta 1 tube — — FDA listed —
Hydrocortisone Cream 1 g/100g 69396-0147-01 Trifecta 1 tube — — FDA listed —
hydrocortisone 1 g/100g 72162-2284-02 Bryant 1 tube — — FDA listed —
Hydrocortisone with Aloe 1 g/100g 11673-0392-02 TARGET 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 72288-0713-64 Amazon.com 1 tube — — FDA listed —
JJ Care 1 g/100g 43473-0116-02 Nantong 144 packets — — FDA listed —
Anti Itch 1 g/100g 42507-0681-64 HyVee 1 tube — — FDA listed —
Hydrocortisone 1 g/100g 72288-0469-25 Amazon.com 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

What it looks like

Size145 mm
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerFront Pharmaceutical PLC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code69571
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio17 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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 1 words ▾

Indication

⏱️ Dosage and Administration 1 words ▾

DOSAGE

⚠️ Warnings 1 words ▾

warning

🧪 Inactive Ingredients 2 words ▾

inactive ingredient

🎯 Purpose 1 words ▾

purpose

📄 Keep Out of Reach of Children 6 words ▾

keep out of reach of children

📄 Package Label / Principal Display Panel 2 words ▾

PACKAGE LABEL

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

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

Medicare Part D (outpatient prescription) spending for Hydrocortisone (matched by generic name) — 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. CMS lists 11 products for this generic; we show the highest-spend one. 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 FifthPulse Hydrocortisone 4oz (this brand).

Top reported reactions

Fatigue5,917
Condition Aggravated5,454
Nausea4,998
Rash4,907
Diarrhoea4,451
Headache4,425
Pain4,423

Age at onset

Neonate332
Infant314
Child1,040
Adolescent683
Adult7,947
Elderly3,424

Reporter sex

66,644 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,427
Death9,793
Life-threatening8,647
Disabling5,601
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 6,429 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

Over-the-counter (OTC) 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Front Pharmaceutical PLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Front Pharmaceutical PLC 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 69571-0014-01 · Front 69571-0016-01 · Front →
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.