CVS Health Maximum Strength Hydrocortisone Hydrocortisone Ointment 10 mg/g Ointment
by CVS Health · 1 TUBE in 1 CARTON (51316-165-28) / 28 g in 1 TUBE
NDC 51316-0165-28
🏷️ FDA NDC (as labeled)
51316-165-28
billing pads the product segment with a zero
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)
51316-165-28
Product NDC
51316-165
11-digit billing NDC
51316016528
RxCUI
203105
UNII
WI4X0X7BPJ
Application #
M017
SPL Set ID
ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3
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
2024-06-01
Route
TOPICAL
Dosage form
OINTMENT
Substance
HYDROCORTISONE
Why two NDCs?
The FDA registers this code as 51316-165-28 — 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 → 51316-0165-28. 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
LabelerCVS Health
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio50 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
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 Ointment?
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statesPetrolatum
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 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
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| hydrocortisone 1 g/100g 45802-0276-03 | Padagis | 1 tube | $0.071 | — | Availability likely | — |
| Good Neighbor Pharmacy Hydrocortisone 1 g/100g 24385-0276-03 | AmerisourceBergen | 1 tube | $0.078 | — | Availability likely | — |
| sunmark Hydrocortisone 1 g/100g 49348-0522-72 | Strategic | 1 tube | $0.078 | — | Availability likely | — |
| Hydrocortisone 1 g/100g 51672-2018-02 | Sun | 1 tube | $0.078 | — | Availability likely | — |
| Hydrocortisone 1 g/100g 70677-1214-01 | STRATEGIC | 1 tube | $0.078 | — | Availability likely | — |
| Hydrocortisone 10 mg/g 00168-0020-16 | E. | 453.6 g | $0.134 | AT | Availability likely | — |
| Good Sense Anti Itch 1 g/100g 00113-0471-64 | L. | 1 tube | — | — | FDA listed | — |
| Maximum Strength Hydrocortisone 1 g/100g 00363-0230-03 | Walgreens | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 00363-1333-01 | Walgreens | 1 tube | — | — | FDA listed | — |
| Aquaphor Itch Relief 1 g/100g 10356-0120-04 | Beiersdorf | 28 g | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 11383-0268-01 | Weeks | 28 g | — | — | FDA listed | — |
| Rite Aid Hydrocortisone 1 g/100g 11822-2685-01 | Rite | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 21922-0098-04 | Encube | 1 tube | — | — | FDA listed | — |
| Maximum Strength Hydrocortisone 1 g/100g 24286-1560-01 | DLC | 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 1 g/100g 37012-0018-02 | Shopko | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 37808-0471-64 | H | 1 tube | — | — | FDA listed | — |
| equaline anti itch 1 g/100g 41163-0471-64 | United | 1 tube | — | — | FDA listed | — |
| Cortizone 10 Water Resistant 1 g/100g 41167-0344-00 | Chattem, | 1 tube | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 50090-6526-00 | A-S | 1 tube | — | — | FDA listed | — |
| CVS Health Maximum Strength Hydrocortisone 10 mg/gthis 51316-0165-28 | CVS | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 63187-0543-01 | Proficient | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 69396-0003-20 | TRIFECTA | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1% 1 g/100g 69396-0017-05 | Trifecta | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 1 g/100g 69396-0149-01 | TRIFECTA | 1 tube | — | — | FDA listed | — |
| Maximum Strength Cortisone 1 g/100g 69842-0259-03 | CVS | 1 tube | — | — | FDA listed | — |
| Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 | ViaDerma | 1 bottle | — | — | FDA listed | — |
| hydrocortisone 1 g/100g 72162-2284-02 | Bryant | 1 tube | — | — | FDA listed | — |
| FixMySkin Healing Balm Fragrance-Free 10 mg/mL 76314-0002-03 | Lovely | 14.78 ml | — | — | FDA listed | — |
| FixMySkin Healing Balm Unflavored 10 mg/mL 76314-0003-01 | Lovely | 4.43 ml | — | — | FDA listed | — |
| FixMySkin Healing Balm Vanilla Flavor 10 mg/mL 76314-0004-01 | Lovely | 4.43 ml | — | — | FDA listed | — |
| anti itch 1 g/100g 79481-0471-00 | Meijer, | 1 tube | — | — | FDA listed | — |
| MediBalm 1 g/100g 85529-0204-01 | BalmRx, | 1 jar | — | — | FDA listed | — |
| Quitch Anit-Ich Healing Body Balm .07 g/7g 87560-0141-92 | Mor | 1 cartridge | — | — | 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
🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.
🔬 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 CVS Health Maximum Strength Hydrocortisone (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 67%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51316-0165-28 You're viewing this | 1 TUBE in 1 CARTON (51316-165-28) / 28 g in 1 TUBE | 2024-06-01 | Active |
🧭 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 51316-165-28, 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: 51316-0165-28, written without dashes as 51316016528. 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 51316-0165-28, the first segment (51316) is the labeler code FDA assigned to CVS Health; the middle segment (0165) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (28) 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 CVS Health. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Health 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 and Cautions
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses ■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should only be under the advice and supervision of a doctor
⏱️ Dosage and Administration ▾
Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily children under 2 years of age: ask a doctor for external anal itching, adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor
⚠️ Warnings and Cautions ▾
Drug Facts
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active ingredient Hydrocortisone 1%
🧪 Inactive Ingredients ▾
Inactive ingredient Petrolatum
🎯 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.