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Dermasporin Lanolin 3.96 g/14.2g Ointment, 14.2 g — NDC 87541-0507-04 package photo

Dermasporin Lanolin 3.96 g/14.2g Ointment, 14.2 g

by Marie's Original Formulas LLC · 14.2 g in 1 TUBE, WITH APPLICATOR (87541-507-04)
NDC 87541-0507-04
🏷️ FDA NDC (as labeled) 87541-507-04 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Lanolin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 27, 2025 — CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. (DermaRite Industries, LLC) · FDA recall D-0171-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 87541-507-04
Product NDC 87541-507
11-digit billing NDC 87541050704
UNII 7EV65EAW6H
Application # M016
SPL Set ID 562f40aa-eeec-2b7c-e063-6294a90ad68d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-10
Route TOPICAL
Dosage form OINTMENT
Substance LANOLIN
Why two NDCs? The FDA registers this code as 87541-507-04 — 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 → 87541-0507-04. 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.

🏭 Manufacturer & labeler

LabelerMarie's Original Formulas LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code87541
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio14 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 is this product?

Dermasporin Lanolin is a topical ointment containing lanolin, a waxy substance derived from sheep's wool. Lanolin is commonly used in over-the-counter skin care products to help soften and moisturize dry or irritated skin. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category of skincare ointments rather than being individually reviewed as a new drug application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 N9PR3490H9
    A naturally derived form of vitamin E that acts as an antioxidant in medicines. It prevents oils and fats in the product from breaking down or becoming rancid during storage.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII BBL281NWFG
    Cod liver oil is a natural oil derived from fish liver that serves as a source of omega-3 fatty acids and vitamins A and D in formulations. It's used as a nutrient supplement ingredient and as an emollient to help soften and smooth the product.
  • UNII DG4F8T839X
    A plant extract from comfrey leaves used as a natural ingredient in formulations. It may serve as a soothing agent or botanical additive in topical or oral preparations.
  • UNII OS64WTR4KU
    Echinacea purpurea root is a plant extract used in supplements and some medicines. It typically serves as an active botanical ingredient rather than a traditional inactive filler or binder.
  • UNII V5IL571C1T
    Ethacridine lactate is a yellow antimicrobial chemical compound used as a preservative in medicines to prevent bacterial and fungal growth during storage and use.
  • UNII ZW3Z11D0JV
    A plant extract from goldenseal root, used as a natural colorant and flavoring agent in some medicines. It may also have mild preservative properties in certain formulations.
  • UNII TA4JCF9S1J
    A plant oil derived from sea buckthorn berries used as a skin-conditioning agent and emollient in topical formulations to help soften and protect the skin.
  • UNII A6V4CUE7PV
    A plant extract from St. John's Wort flowers used as a coloring agent and botanical additive in some formulations. It may provide natural pigmentation and traditional herbal properties to the medicine.
  • UNII SZH16H44UY
    A fragrant essential oil extracted from juniper berries, used as a flavoring agent and fragrance component in medicines to improve taste or aroma.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII Z1CLM48948
    Nutmeg oil is a natural aromatic extract from nutmeg seeds. It's used in medicines as a flavoring agent to improve taste and sometimes as a fragrance to mask bitter or unpleasant odors.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 7QWM220FJH
    Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesAloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Oil, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Butter, Emulsifying Wax NF, Echinacea Purpurea Extract, Ethacridine Lactate Monohydrate, Hippophae Rhamnoides (Sea Buckthorn) Extract, Hydrastis Canadensis Root Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Juniperus Communis Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Oleum Morrhuae (Cod Liver) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Symphytum Officinale (Comfrey) Extract, Tocopheryl Acetate, Syzygium Aromaticum (Clove) Oil, Zinc Oxide.

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.
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
Dermasporin 3.96 g/14.2gthis 87541-0507-04 Marie's 14.2 g — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87541-0507-04 You're viewing this 14.2 g in 1 TUBE, WITH APPLICATOR (87541-507-04) 2026-07-10 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 87541-507-04, 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: 87541-0507-04, written without dashes as 87541050704. 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 87541-0507-04, the first segment (87541) is the labeler code FDA assigned to Marie's Original Formulas LLC; the middle segment (0507) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Marie's Original Formulas LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Marie's Original Formulas LLC 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 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 10 words ▾

Usage • Helps temporarily protect minor cuts, scrapes, and burns.

⏱️ Dosage and Administration 18 words ▾

Directions • Clean the affected area. • Apply as needed. • May be covered with a sterile bandage.

⚠️ Warnings 59 words ▾

Warnings For external use only. Do not use • On deep or puncture wounds. • On animal bites. • On serious burns. When using this product • Do not get into eyes. Stop use and ask a doctor if • Condition worsens. • Symptoms last more than 7 days or clear up and occur again within a few days.

🧪 Inactive Ingredients 88 words ▾

Inactive ingredients Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Oil, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Butter, Emulsifying Wax NF, Echinacea Purpurea Extract, Ethacridine Lactate Monohydrate, Hippophae Rhamnoides (Sea Buckthorn) Extract, Hydrastis Canadensis Root Extract, Hypericum Perforatum (St. John's Wort) Flower Extract, Juniperus Communis Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Oleum Morrhuae (Cod Liver) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Symphytum Officinale (Comfrey) Extract, Tocopheryl Acetate, Syzygium Aromaticum (Clove) Oil, Zinc Oxide.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87541-0498-25 · Marie's 87541-0518-15 · Marie's →
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.