astonea Hydrocortisone 10 mg/g Cream, 9 g
by ASTONEA LABS PRIVATE LIMITED · .9 g in 1 PACKET (77338-305-02)
NDC 77338-0305-02
🏷️ FDA NDC (as labeled)
77338-305-02
billing pads the product segment with a zero
This package
Contains9 g
Pack sizes3 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
77338-305-02
Product NDC
77338-305
11-digit billing NDC
77338030502
RxCUI
1043690
UNII
3X7931PO74
Application #
M017
SPL Set ID
de09e859-c5fd-0cc5-e053-2a95a90a147e
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
2022-05-02
Route
TOPICAL
Dosage form
CREAM
Substance
HYDROCORTISONE ACETATE
Why two NDCs?
The FDA registers this code as 77338-305-02 — 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 → 77338-0305-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Pharmacologic class
Corticosteroid
Drug family (ATC)
Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works
Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerASTONEA LABS PRIVATE LIMITED
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code77338
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio7 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📖 What it is MedlinePlus · NLM
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
- What exactly is this cream supposed to do for my skin?
- That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
- How long can I keep using it? Is it okay to use every day long-term?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Hydrocortisone — tap one for details:
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.
ZINC
Insignificant Depletion
CALCIUM
Moderate Depletion
CHROMIUM
Moderate Depletion
MAGNESIUM
Moderate Depletion
POTASSIUM
Moderate Depletion
+3 more
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.
💬 Questions about Hydrocortisone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per g | Per 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
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Walgreens Eczema Relief 10 mg/g 00363-0357-02 | Walgreen | 1 tube | — | — | FDA listed | — |
| Hydrocortisone Acetate 10 mg/g 47832-0205-05 | Bentlin | 576 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 50332-0042-01 | HART | 10 packets | — | — | FDA listed | — |
| Hydrocortisone 10 mg/g 50332-0092-01 | HART | 10 packets | — | — | FDA listed | — |
| MedPride 10 mg/g 52410-3050-02 | Shield | 9 g | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 59898-0800-01 | Water-Jel | 1728 packets | — | — | FDA listed | — |
| Gerigentle 10 mg/g 69771-0192-13 | GERI-GENTLE | 28.3 g | — | — | FDA listed | — |
| American Safety and First Aid 10 mg/g 71927-0015-02 | Orazen | 25 pouches | — | — | FDA listed | — |
| astonea 10 mg/gthis 77338-0305-02 | ASTONEA | 9 g | — | — | FDA listed | — |
| Equate Hydrocortione 10 mg/g 79903-0211-01 | Walmart | 1 tube | — | — | FDA listed | — |
| ElixirCortiRelief 1 g/100g 84546-0005-01 | ELIXIR | 1 tube | — | — | FDA listed | — |
| Thompson Hydrocortisone 1% 10 mg/g 73408-0981-73 | Thompson | 25 packets | — | — | FDA listed | — |
| Green Guard Hydrocortisone 1% 10 mg/g 47682-0398-73 | Unifirst | 25 packets | — | — | 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
🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 years 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.
📊 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 77338-0305-02 You're viewing this | .9 g in 1 PACKET (77338-305-02) | 2022-05-02 | Active |
| 77338-0305-03 | 28.3 g in 1 TUBE (77338-305-03) | 2022-05-02 | Active |
| 77338-0305-06 | 454 g in 1 JAR (77338-305-06) | 2022-05-02 | Active |
Pack size FAQ
What quantity is in NDC 77338-0305-02?
NDC 77338-0305-02 contains 9 g — .9 g in 1 packet.
What is the difference between NDC 77338-0305-02 and NDC 77338-0305-03?
Both are astonea Hydrocortisone 10 mg/g Cream — the drug itself is identical. NDC 77338-0305-02 is the 9 g package, while NDC 77338-0305-03 is the 28.3 g package.
What NDC number is used to bill for this package of astonea Hydrocortisone 10 mg/g Cream?
Bill NDC 77338-0305-02 — the 11-digit billing format is 77338030502. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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) | — 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 | — 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 FDA registers it as 77338-305-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 77338-0305-02, written without dashes as 77338030502. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 77338-0305-02, the first segment (77338) is the labeler code FDA assigned to ASTONEA LABS PRIVATE LIMITED; the middle segment (0305) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ASTONEA LABS PRIVATE LIMITED. 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 2 other package presentations of this same product, including 28.3 g (77338-0305-03), 454 g (77338-0305-06). 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?
ASTONEA LABS PRIVATE LIMITED 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.
📄 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
🎯 Indications and Usage ▾
Uses ■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor
⏱️ Dosage and Administration ▾
Directions ■ adults and children over 2 years of age ■ apply evenly to affected area no more than 3 to 4 times daily ■ children under 2 years of age■ do not use, consult a doctor ■ Adults ■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly ■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying ■ apply externally to the area up to 6 times a daily or after a bowel movement ■ after application discard pad ■ do not flush in toilet
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active Ingredient Hydrocortisone Acetate USP (1% w/w)
🧪 Inactive Ingredients ▾
Inactive Ingredients cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin
🎯 Purpose ▾
Purpose Anti-itch
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.