HomeNDC LookupIngredientsFemarone 20 › 87250-0001-11
Femarone 20 20 mg/58g Cream, 58 g — NDC 87250-0001-11 package photo

Femarone 20 20 mg/58g Cream, 58 g

by Wise Essentials LLC · 58 g in 1 JAR (87250-001-11)
NDC 87250-0001-11
🏷️ FDA NDC (as labeled) 87250-001-11 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) 87250-001-11
Product NDC 87250-001
11-digit billing NDC 87250000111
UNII 4G7DS2Q64Y
SPL Set ID 44ea74ce-2ba1-e578-e063-6394a90ab72d
Established class (EPC) Progesterone
Chemical class Progesterone
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-05
Route TRANSDERMAL
Dosage form CREAM
Substance PROGESTERONE
Why two NDCs? The FDA registers this code as 87250-001-11 — 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 → 87250-0001-11. 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

LabelerWise Essentials LLC
Labeler code87250
First marketedDec 2025
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

📗 Our plain-language guide HelloPharmacist
  • When you still have your uterus and you're taking estrogen, estrogen can cause the lining of your uterus to grow too thick — a condition called endometrial hyperplasia, which can i...
  • Why do I need to take progesterone if I'm already on estrogen?
  • Yes, and it's important to be honest about this. Large studies have shown that taking estrogen combined with progestin — including progesterone — is associated with a higher risk o...
  • Is it true that taking progesterone with estrogen can raise my risk of breast cancer or stroke?
📖 Read our full Progesterone guide →
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.

  • 2.5 mg / 58 g UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 2.5 mg / 58 g UNII 433OSF3U8A
    A plant extract from the chaste tree fruit, used as a flavoring agent or botanical ingredient to add taste or aroma to the medicine.
  • 40 mg / 58 g 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.
  • 80 mg / 58 g UNII IWY3IWX2G8
    A plant extract derived from wild yam root. It's used in medicines as a natural binding and thickening agent to help hold ingredients together and improve the product's texture and consistency.
  • 30 mg / 58 g 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.
  • 5 mg / 58 g 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.
  • 2.5 mg / 58 g UNII EM5RP35463
    A plant extract from radish root used as a natural flavoring agent and colorant in medicines. It adds taste and visual appeal to oral formulations like tablets and liquids.
  • 20 mg / 58 g UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.

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

The official label also statesWater, Wild Yam Extract, Chaste Tree Berry, Coconut Oil Organic, Vegetable Glycerin USP, Emulsifying Wax NF, Olivem 1000, Glyceryl Stearate, Radish Root Extract, Aloe Vera Powder Organic, Jojoba Oil Organic, Allantoin, Shea Butter Organic

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 DailyMedingredient 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
Femarone 20 20 mg/58gthis 87250-0001-11 Wise 58 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87250-0001-11 You're viewing this 58 g in 1 JAR (87250-001-11) 2025-12-06 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 87250-001-11, 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: 87250-0001-11, written without dashes as 87250000111. 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 87250-0001-11, the first segment (87250) is the labeler code FDA assigned to Wise Essentials LLC; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 Wise Essentials LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wise Essentials 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 66 words

INDICATIONS AND USAGE USES: This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones and also to provide support for perimenopause and menopause. Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply or use as directed by your physician.

⏱️ Dosage and Administration 27 words

DOSAGE & ADMINISTRATION Apply once or twice a day. Massage into wrists, inner arms, thighs, chest, or apply to together or use as directed by your physician.

⚠️ Warnings 109 words

WARNINGS: If pregnant or nursing or if you have a serious medical condition, consult a healthcare professional before using this product. KEEP OUT OF REACH OF CHILDREN Store in a cool, dry place Always consult your healthcare provider before using or if pregnant or nursing. Cease use and seek medical attention if skin irritation or a negative reaction.

Keep out of reach of children. Store in a cool, dry place. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer.

Cease using this product and seek medical attention if skin irritation or other negative reactions occur.

🤰 Pregnancy 23 words

PREGNANCY OR BREASTFEEDING If pregnant or nursing or if you have a serious medical condition, consult a healthcare professional before using this product.

🧪 Active Ingredient 45 words

Active Ingredient Micronized Progesterone USP, (Wild Yam) 2%

DISCLAIMER Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs For further information about unapproved drugs, https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs

🧪 Inactive Ingredients 36 words

INACTIVE INGREDIENT Water, Wild Yam Extract, Chaste Tree Berry, Coconut Oil Organic, Vegetable Glycerin USP, Emulsifying Wax NF, Olivem 1000, Glyceryl Stearate, Radish Root Extract, Aloe Vera Powder Organic, Jojoba Oil Organic, Allantoin, Shea Butter Organic

🎯 Purpose 43 words

PURPOSE This is a topical cream that contains bio-identical micronized USP progesterone derived from wild yam, blended with phytoestrogens. When applied topically to the skin, it may help to balance your hormones, and also to provide support for peri menopause and menopausal symptoms.

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.