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American Safety and First Aid HYDROCORTISONE ACETATE 10 mg/g Cream, 25 pouches — NDC 71927-0015-02 package photo

American Safety and First Aid HYDROCORTISONE ACETATE 10 mg/g Cream, 25 pouches

by Orazen Inc · 25 POUCH in 1 BOX (71927-015-02) / .9 g in 1 POUCH (71927-015-01)
NDC 71927-0015-02
🏷️ FDA NDC (as labeled) 71927-015-02 billing pads the product segment with a zero
This package
Contains25 pouches Pack sizes2 compare ↓
Also comes in: 144 pouches 71927-0015-03
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 71927-015-02
Product NDC 71927-015
11-digit billing NDC 71927001502
RxCUI 1043690
UNII 3X7931PO74
Application # M017
SPL Set ID eb0cce4b-c70a-1b2d-e053-2995a90aa4aa
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 2022-10-17
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE ACETATE
Why two NDCs? The FDA registers this code as 71927-015-02 — 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 → 71927-0015-02. 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

LabelerOrazen Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code71927
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio25 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?
📖 Read our full Hydrocortisone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

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

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

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 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 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 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 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 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.

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

The official label also statesCetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water

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.

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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/gthis 71927-0015-02 Orazen 25 pouches — — FDA listed —
astonea 10 mg/g 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 —
Medi-First 10 mg/g 71927-0032-02 Orazen 25 pouches — — FDA listed —
Medi-First Hydrocortisone 1% 10 mg/g 47682-0207-12 Unifirst 10 packets — — FDA listed —
American Safety and First Aid 10 mg/g 71927-0031-02 Orazen 25 pouches — — FDA listed —
Medi-First 1% Hydrocortisone 10 mg/g 47682-0923-73 Unifirst 25 packets — — FDA listed —
Medi First Plus 10 mg/g 71927-0033-02 Orazen 25 pouches — — 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
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Acetate (matched by generic name) — 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 Hydrocortisone Acetate. CMS lists 2 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
$497.1K
Claims incl. refills
345
Beneficiaries
236
Spend / beneficiary
$2,106.25
Spend / claim
$1,440.80
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for HYDROCORTISONE ACETATE — the ingredient across all brands.

Top reported reactions

Fatigue7,475
Condition Aggravated6,634
Rash6,312
Pain6,012
Nausea5,718
Arthralgia5,321
Diarrhoea5,317

Age at onset

Neonate341
Infant320
Child1,078
Adolescent717
Adult8,798
Elderly3,694

Reporter sex

73,227 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization30,805
Death10,771
Life-threatening9,679
Disabling6,943
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 7,147 3,005
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71927-0015-02 You're viewing this 25 POUCH in 1 BOX (71927-015-02) / .9 g in 1 POUCH (71927-015-01) 2022-10-17 Active
71927-0015-03 144 POUCH in 1 BOX (71927-015-03) / .9 g in 1 POUCH (71927-015-01) 2022-10-17 Active

Pack size FAQ

What quantity is in NDC 71927-0015-02?
NDC 71927-0015-02 contains 25 pouches — 25 pouch in 1 box / .9 g in 1 pouch.
What is the difference between NDC 71927-0015-02 and NDC 71927-0015-03?
Both are American Safety and First Aid HYDROCORTISONE ACETATE 10 mg/g Cream — the drug itself is identical. NDC 71927-0015-02 is the 25 pouches package, while NDC 71927-0015-03 is the 144 pouches package.
What NDC number is used to bill for this package of American Safety and First Aid HYDROCORTISONE ACETATE 10 mg/g Cream?
Bill NDC 71927-0015-02 — the 11-digit billing format is 71927001502. 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) ✓ 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 71927-015-02, 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: 71927-0015-02, written without dashes as 71927001502. 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 71927-0015-02, the first segment (71927) is the labeler code FDA assigned to Orazen Inc; the middle segment (0015) 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 Orazen 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 1 other package presentation of this same product, including 144 pouches (71927-0015-03). 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?
Orazen 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.

📄 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 29 words ▾

Uses for the temporary relief of itching associated with minor irritations and rashes Other uses of this product should be only under the advice and supervision of a doctor

⏱️ Dosage and Administration 31 words ▾

Directions 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

⚠️ Warnings 38 words ▾

Warnings For external use only Do not use for the treatment of diaper rash. Consult a doctor. Complete Warnings See Card or Box Keep out of reach of children. If swallowed contact a Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active Ingredient Hydrocortisone Acetate 1% Purpose Anti-Itch Cream

🧪 Inactive Ingredients 15 words ▾

Inactive Ingredients Cetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water

🎯 Purpose 3 words ▾

Purpose Anti-Itch Cream

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71927-0014-01 · Orazen 71927-0016-02 · Orazen →
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.