FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE 10 mg/mL Ointment, 14.78 mL
by Lovely Skin, Inc. · 14.78 mL in 1 PACKAGE (76314-002-03)
NDC 76314-0002-03
🏷️ FDA NDC (as labeled)
76314-002-03
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)
76314-002-03
Product NDC
76314-002
11-digit billing NDC
76314000203
RxCUI
203105
UNII
WI4X0X7BPJ
UPC
0376314000099
Application #
M017
SPL Set ID
c12af4c6-2f05-46ec-b901-1a4fcd750180
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
2009-12-31
Route
TOPICAL
Dosage form
OINTMENT
Substance
HYDROCORTISONE
Why two NDCs?
The FDA registers this code as 76314-002-03 — 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 → 76314-0002-03. 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
LabelerLovely Skin, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76314
First marketedDec 2009
Product typeHuman Otc Drug
Portfolio3 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII A9EJ3J61HQ
A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
-
UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
-
UNII 512OYT1CRR
Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
-
UNII 412ZHA4T4Y
A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
-
UNII O88E196QRF
Sheanut oil is a natural fat extracted from shea nuts grown in Africa. It's used in medicines as an emollient, lubricant, and binding agent to improve texture, help ingredients mix smoothly, and keep the product stable.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII L7HT8F1ZOD
A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
-
UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesRicinus Communis (Castor) Seed Oil, Stearyl Alcohol, C12-15 Alkyl Benzoate, Meadow Foam (Limnanthes Alba) Seed Oil, Shea Butter (Butyrospermum Parkil) Extract, Beeswax, Glycine Soja (Soybean) Germ Extract, Zea Mays (Corn) Starch, Silica, Theobroma Cacao (Cocoa) Seed Butter.
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/g 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/mLthis 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 | — |
| Total Relief 10 mg/mL 71516-0342-00 | DR. | 180 ml | — | — | FDA listed | — |
| Alumier MD Intensive Recovery 10 mg/mL 69473-0017-01 | Alumier | 1 tube | — | — | FDA listed | — |
| Hydrocortisone 10 mg/mL 71399-0120-01 | AKRON | 1 bottle | — | — | FDA listed | — |
| Dermarest Eczema Medicated 10 mg/mL 63736-0339-24 | Insight | 1 bottle | — | — | FDA listed | — |
| Nizoral Scalp Itch Relief 10 mg/mL 55505-0222-29 | Kramer | 1 bottle | — | — | FDA listed | — |
| Absolut Skin Corticosoothe Anti-Itch 10 mg/mL 87184-0899-00 | Absolut | 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
🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 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.
🔬 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 FixMySkin Healing Balm Fragrance-Free (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
Unknown · 0%
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 |
|---|---|---|---|
| 76314-0002-03 You're viewing this | 14.78 mL in 1 PACKAGE (76314-002-03) | 2011-11-17 | 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 76314-002-03, 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: 76314-0002-03, written without dashes as 76314000203. 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 76314-0002-03, the first segment (76314) is the labeler code FDA assigned to Lovely Skin, Inc.; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Lovely Skin, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lovely Skin, 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
📋 Description
🎯 Indications and Usage ▾
Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.
⏱️ Dosage and Administration ▾
Directions For itching associated with skin irritation, inflammation and rashes: Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use - consult a doctor.
⚠️ Warnings ▾
Warnings For external use only. Avoid contact with eyes.
🧪 Active Ingredient ▾
Active Ingredient & Purpose Active Ingredient Purpose Hydrocortisone 1% ....................................................................Antipruritic, External Analgesic
🧪 Inactive Ingredients ▾
Inactive Ingredients Ricinus Communis (Castor) Seed Oil, Stearyl Alcohol, C12-15 Alkyl Benzoate, Meadow Foam (Limnanthes Alba) Seed Oil, Shea Butter (Butyrospermum Parkil) Extract, Beeswax, Glycine Soja (Soybean) Germ Extract, Zea Mays (Corn) Starch, Silica, Theobroma Cacao (Cocoa) Seed Butter.
🎯 Purpose ▾
Purpose Antipruritic, External Analgesic
📋 Description ▾
Description Formulated by a board-certified dermatologist and his son. Dr. Joel Schlessinger and his son, Daniel Schlessinger, embarked on a five year quest to find the best balm product in a stick formulation for dry skin and irritation.
After 54 different formulas, they finally came up with this patent pending formula. It is great for dry skin and helps improve the signs and symptoms of dry skin due to eczema, medications, psoriasis and other dry skin conditions. It is also available in the LovelySkin line without hydrocortisone (www.LovelySkin.com/Balm).
Visit www.FixMySkin.com/Story for the whole story on how this product was developed.
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.