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CAREALL Hydrocortisone Maximum Strength .01 g/g Cream, 28 g — NDC 51824-0114-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CAREALL Hydrocortisone Maximum Strength .01 g/g Cream, 28 g — NDC 51824-114-01 (Billing 51824-0114-01)

by New World Imports, Inc. · 28 g in 1 CONTAINER

This is a package of 28 g of CAREALL Hydrocortisone Maximum Strength .01 g/g Cream from New World Imports, Inc., marketed since Aug 2026 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 51824-0114-01
🏷️ FDA NDC (as labeled) 51824-114-01 billing pads the product segment with a zero
This package
Contains28 g Pack sizes4 compare ↓
Main listing for product 51824-114 · Also comes in: 9 g 51824-114-09 25 packets 51824-114-25 144 packets 51824-114-14
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 51824-114-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51824 labeler · 114 product · 01 package
Package marketed since
Aug 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0085317007553
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51824-114-01
Product NDC 51824-114
11-digit billing NDC 51824011401
RxCUI 106258
UNII WI4X0X7BPJ
UPC 0085317007553
Application # M017
SPL Set ID 560a4abf-31dd-333f-e063-6294a90a3505
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 2026-08-01
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
Quick answers
  • RxCUI (RxNorm): 106258
Why two NDCs? The FDA registers this code as 51824-114-01 — 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 → 51824-0114-01. 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.

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.
Try another pack size: 9 g 25 packets 144 packets
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
51824-0114-01 You're viewing this Main listing 28 g in 1 CONTAINER 2026-08-01 — Active
51824-0114-09 51824-114-09 .9 g in 1 PACKET 2026-08-01 — Active
51824-0114-14 51824-114-14 144 PACKET in 1 CARTON / .9 g in 1 PACKET 2026-08-01 — Active
51824-0114-25 51824-114-25 25 PACKET in 1 CARTON / .9 g in 1 PACKET 2026-08-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 28 g — 28 g in 1 container.
How does this package differ from NDC 51824-0114-09?
Both are CAREALL Hydrocortisone Maximum Strength .01 g/g Cream — the drug itself is identical. This page's package is the 28 g one, while NDC 51824-0114-09 is the 9 g package.
What NDC number is used to bill for this package of CAREALL Hydrocortisone Maximum Strength .01 g/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Hydrocortisone With Aloe .01 g/g 70000-0543-01 LEADER 1 tube $0.056 — FDA listed —
Rugby Hydrocortisone With Aloe .01 g/g 50090-5470-00 A-S 1 tube — — FDA listed —
Herb Street Anti-Itch Stick .01 g/g 10107-0429-02 Balassa 1 tube — — FDA listed —
Xpect Hydrocortisone .01 g/g 42961-0237-02 Cintas 10 packets — — FDA listed —
Gembooxt ECZEMA RELIEF Cream .01 g/g 76986-0019-01 Guangdong 2 bottles — — FDA listed —
Aquanil HC .01 g/g 00096-0732-04 Person 118 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 —
Natureplex Hydrocortisone Hydro .01 g/g 67234-0010-01 Natureplex, 28 g — — FDA listed —
Equate Hydrocortisone Topical .01 g/g 79903-0091-01 WalMart 1 tube — — FDA listed —
Hydrocortisone Anti-Itch .01 g/g 52000-0022-37 Universal 1 tube — — Discontinued —
Aquanil HC .01 g/g 00096-0810-04 Person 118 g — — FDA listed —
CAREALL Hydrocortisone Maximum Strength .01 g/g 51824-0097-01 New 28 g — — FDA listed —
LYEON Anti-itch Cream .01 g/g 87681-0008-01 Guangzhou 2 bottles — — FDA listed —
CAREALL Hydrocortisone Maximum Strength .01 g/gthis 51824-0114-01 New 28 g — — 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Hydrocortisone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statesCeteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl 1-stearate, Mineral Oil, Phenoxyethanol, Water, White Petrolatum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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

LabelerNew World Imports, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code51824
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from New World Imports, Inc. labeler code 51824

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 47 words ▾

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: ezcema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap other uses of this product should be only under the advice and supervision of a doctor

⏱️ Dosage and Administration 33 words ▾

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age do not use. Ask a doctor.

⚠️ Warnings 141 words ▾

For External use only. Do not use for the treatment of diaper rash, Consult a doctor. If you have vaginal discharge, consult a doctor.

When using this product: avoid contact with eyes do not use more than directed unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator if rectal bleeding occurs, consult a docto promptly Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocrotisone product unless you have consulted a doctor. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a physician.

🧪 Active Ingredient 4 words ▾

Active Ingredient Hydrocortisone 1%

🧪 Inactive Ingredients 13 words ▾

Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl 1-stearate, Mineral Oil, Phenoxyethanol, Water, White Petrolatum

🎯 Purpose 4 words ▾

Itch and Rash Relief

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. if swallowed, get medical help or contat a poinson control center right away.

📄 Package Label / Principal Display Panel 4 words ▾

pdp pdp pdp pdp

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 CAREALL Hydrocortisone Maximum Strength (this brand).

Top reported reactions

Fatigue5,919
Condition Aggravated5,454
Nausea4,998
Rash4,908
Diarrhoea4,449
Headache4,425
Pain4,422

Age at onset

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

Reporter sex

66,647 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,426
Death9,794
Life-threatening8,648
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 New World Imports, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 9 g (51824-0114-09), 25 packets (51824-0114-25), 144 packets (51824-0114-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
New World Imports, 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 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.
← 51824-0110-02 · New 51824-0116-01 · New →
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.