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FixMySkin Healing Balm Unflavored HYDROCORTISONE 10 mg/mL Ointment, 1 mL — NDC 76314-0003-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FixMySkin Healing Balm Unflavored HYDROCORTISONE 10 mg/mL Ointment, 1 mL — NDC 76314-003-02 (Billing 76314-0003-02)

by Lovely Skin, Inc. · 1 mL in 1 PACKET

This is a package of 1 mL of FixMySkin Healing Balm Unflavored HYDROCORTISONE 10 mg/mL Ointment from Lovely Skin, Inc., marketed since Nov 2011 and currently FDA-listed.

NDC 76314-0003-02
🏷️ FDA NDC (as labeled) 76314-003-02 billing pads the product segment with a zero
This package
Contains1 mL Pack sizes2 compare ↓
Product page 76314-0003-01 Also comes in: 4.43 ml 76314-003-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 76314-003-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76314 labeler · 003 product · 02 package
Package marketed since
Nov 17, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0857592008972
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76314-003-02
Product NDC 76314-003
11-digit billing NDC 76314000302
RxCUI 203105
UNII WI4X0X7BPJ
UPC 0857592008972
Application # M017
SPL Set ID 9ff8db07-ad6d-4865-a534-94bd8312957e
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 2011-11-17
Route TOPICAL
Dosage form OINTMENT
Substance HYDROCORTISONE
Quick answers
  • RxCUI (RxNorm): 203105
Why two NDCs? The FDA registers this code as 76314-003-02 — 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 → 76314-0003-02. 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.

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: 4.43 ml
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
76314-0003-01 76314-003-01 Main listing 4.43 mL in 1 PACKAGE 2011-11-17 — Active
76314-0003-02 You're viewing this 1 mL in 1 PACKET 2011-11-17 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 mL — 1 ml in 1 packet.
How does this package differ from NDC 76314-0003-01?
Both are FixMySkin Healing Balm Unflavored HYDROCORTISONE 10 mg/mL Ointment — the drug itself is identical. This page's package is the 1 mL one, while NDC 76314-0003-01 is the 4.43 ml package.
What NDC number is used to bill for this package of FixMySkin Healing Balm Unflavored HYDROCORTISONE 10 mg/mL Ointment?
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
hydrocortisone 1 g/100g 45802-0276-03 Padagis 1 tube $0.070 — Availability likely —
Good Neighbor Pharmacy Hydrocortisone 1 g/100g 24385-0276-03 AmerisourceBergen 1 tube $0.077 — Availability likely —
sunmark Hydrocortisone 1 g/100g 49348-0522-72 Strategic 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 51672-2018-02 Sun 1 tube $0.077 — Availability likely —
Hydrocortisone 1 g/100g 70677-1214-01 STRATEGIC 1 tube $0.077 — Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.138 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/mL 76314-0002-03 Lovely 14.78 ml — — FDA listed —
FixMySkin Healing Balm Unflavored 10 mg/mLthis 76314-0003-02 Lovely 1 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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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.

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 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.

Manufacturer & labeler

LabelerLovely Skin, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code76314
First marketedNov 2011
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Lovely Skin, Inc. labeler code 76314

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 📋 Description 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 words ▾

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 45 words ▾

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 9 words ▾

Warnings For external use only. Avoid contact with eyes.

🧪 Active Ingredient 12 words ▾

Active Ingredient & Purpose Active Ingredient Purpose Hydrocortisone 1% ....................................................................Antipruritic, External Analgesic

🧪 Inactive Ingredients 39 words ▾

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 4 words ▾

Purpose Antipruritic, External Analgesic

📋 Description 100 words ▾

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.

📄 Do Not Use 12 words ▾

Do not use for the treatment of diaper rash. Consult a doctor.

📄 Stop Use and Ask a Doctor If 48 words ▾

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children Keep out of reach of children

📄 Questions or Comments 6 words ▾

Questions or Comments? www.FixMySkin.com [email protected] (402)697-1100

📄 Package Label / Principal Display Panel 12 words ▾

FixMySkin Healing Balm Unflavored 0.15oz/4.43ml (76314-003-01) Representative Labeling 1 1 2 3

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 FixMySkin Healing Balm Unflavored (this brand).

Top reported reactions

Fatigue5,917
Condition Aggravated5,454
Nausea4,998
Rash4,907
Diarrhoea4,451
Headache4,425
Pain4,423

Age at onset

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

Reporter sex

0 reports

Serious outcomes

Hospitalization28,427
Life-threatening8,647
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 6,429 2,806
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 Lovely Skin, 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 4.43 ml (76314-0003-01). 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?
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.
← 76314-0002-03 · Lovely 76314-0004-01 · Lovely →
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.