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BUNUSS Phyto-Pro Skin Cream PROGESTERONE 16.9 mg/mL Paste, 120 mL — NDC 84867-0030-01 package photo

BUNUSS Phyto-Pro Skin Cream PROGESTERONE 16.9 mg/mL Paste, 120 mL

by Jiashen International Trade Limited · 120 mL in 1 BOTTLE (84867-030-01)
NDC 84867-0030-01
🏷️ FDA NDC (as labeled) 84867-030-01 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 Progesterone (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 27, 2024 — Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. (Eugia US LLC) · FDA recall D-0186-2025
Class II · Jul 26, 2024 — Presence of Particulate Matter: Complaint received of a glass particle in the vial. (Eugia US LLC) · FDA recall D-0624-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 84867-030-01
Product NDC 84867-030
11-digit billing NDC 84867003001
UNII 4G7DS2Q64Y
SPL Set ID 44e1ec89-e2ea-d438-e063-6294a90a41f4
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 2025-12-01
Route TOPICAL
Dosage form PASTE
Substance PROGESTERONE
Why two NDCs? The FDA registers this code as 84867-030-01 — 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 → 84867-0030-01. 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

LabelerJiashen International Trade Limited
Labeler code84867
First marketedDec 2025
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

📗 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.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII 8INO2K35FA
    A silicone-based compound that mixes oil and water components together. It acts as an emulsifier and helps distribute ingredients evenly throughout the formulation, improving texture and stability.
  • UNII K73E24S6X9
    A plant extract derived from black cohosh root, used primarily as a natural flavoring or botanical ingredient in formulations. It may also function as a preservative or processing agent.
  • 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.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII 7TRV45YZF7
    A plant extract from Japanese knotweed root used as a natural ingredient. It functions as an antioxidant and preservative to help maintain product stability and shelf life.
  • UNII 892O4599HF
    A plant extract from the pueraria mirifica root used in dietary supplements and some formulations as a natural ingredient and potential texture or consistency modifier in tablets and capsules.
  • UNII PET93F4I3C
    A plant extract from kudzu root used as a binder and filler in tablets and capsules. It helps hold the medicine's ingredients together and adds bulk to the dosage form.
  • UNII M6S840WXG5
    Purslane is a plant-derived ingredient used in pharmaceuticals as a natural source of beneficial compounds. It functions as an antioxidant and anti-inflammatory agent to help stabilize the formula and support product shelf life.
  • 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 71B37NR06D
    Soy isoflavones are natural plant compounds extracted from soybeans. They are used in dietary supplements and some medications as an active botanical ingredient to support formulation claims, though they function as an additive rather than a traditional inactive excipient.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII S2ULN37C9R
    A synthetic chemical compound derived from vanillin that acts as a flavoring agent and fragrance enhancer in medicines. It provides vanilla-like taste and aroma to improve the palatability of oral medications.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesWATER BUTYLENE GLYCOL GLYCERIN TOCOPHERYL ACETATE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL SQUALANE VITIS VINIFERA (GRAPE) SEED OIL MAGNESIUM SULFATE POLYGLYCERYL-3 DIISOSTEARATE CETYL PEG/PPG-10/1 DIMETHICONE PEG-30 DIPOLYHYDROXYSTEARATE 1,2-HEXANEDIOL SOY ISOFLAVONES POLYGONUM CUSPIDATUM ROOT EXTRACT PUERARIA LOBATA ROOT EXTRACT VANILLYL BUTYL ETHER BUTYROSPERMUM PARKII (SHEA BUTTER) CENTELLA ASIATICA EXTRACT PUERARIA MIRIFICA ROOT EXTRACT MENTHOLUM CIMICIFUGA RACEMOSA ROOT EXTRACT PORTULACA OLERACEA EXTRACT LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL

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
BUNUSS Phyto-Pro Skin Cream 16.9 mg/mLthis 84867-0030-01 Jiashen 120 ml — — 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Progesterone (matched by generic name) — the program that covers self-administered drugs. 2 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 Progesterone. 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
$2.4K
Claims incl. refills
60
Beneficiaries
51
Spend / beneficiary
$46.14
Spend / claim
$39.22
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 BUNUSS Phyto-Pro Skin Cream (this brand).

Top reported reactions

Headache1,743
Fatigue1,496
Pain1,245
Nausea1,235
Foetal Exposure During Pregnancy868
Rash850
Dizziness774

Age at onset

Neonate229
Infant27
Child9
Adolescent22
Adult2,853
Elderly387

Reporter sex

19,114 reports
Male · 4%
Female · 96%
Unknown · 0%

Serious outcomes

Hospitalization3,039
Disabling541
Death427
Life-threatening373
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,175 0
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 NDCDescription Marketing startStatus
84867-0030-01 You're viewing this 120 mL in 1 BOTTLE (84867-030-01) 2025-12-01 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 84867-030-01, 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: 84867-0030-01, written without dashes as 84867003001. 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 84867-0030-01, the first segment (84867) is the labeler code FDA assigned to Jiashen International Trade Limited; the middle segment (0030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Jiashen International Trade Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Jiashen International Trade Limited 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
🎯 Indications and Usage 42 words ▾

Apply an appropriate amount of thisproduct to clean, dry, and thin skin areassuch as hands, feet, inner elbows, behindknees, or abdomen for optimal relief.Gently massage until absorbed. Ensurethat the product has been fullyabsorbed, wash hands after application,and avoid direct exposure to sunlight

⏱️ Dosage and Administration 31 words ▾

Apply one pump once or twice daily.To complement your skin's sensitivityduring your monthly rhythm, a pattern of3 weeks of use with a 1-week pause isrecommended (or as directed by a doctor)

⚠️ Warnings 67 words ▾

Storage & Safety Instructions:As a precautionary measure,consultation with a physician is advisedprior to use for individuals who arepregnant, breastfeeding, planning apregnancy, taking any medication, orhave been diagnosed with a medicalcondition.For external use only. Not for oralconsumption. As with any product, incase of rash or irritation, discontinue use.Keep out of reach of children.

Do not useif the safety seal is damaged or missing.Store in a cool, dry place.

🧪 Active Ingredient 1 words ▾

Progesterone

🧪 Inactive Ingredients 63 words ▾

WATER BUTYLENE GLYCOL GLYCERIN TOCOPHERYL ACETATE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL SQUALANE VITIS VINIFERA (GRAPE) SEED OIL MAGNESIUM SULFATE POLYGLYCERYL-3 DIISOSTEARATE CETYL PEG/PPG-10/1 DIMETHICONE PEG-30 DIPOLYHYDROXYSTEARATE 1,2-HEXANEDIOL SOY ISOFLAVONES POLYGONUM CUSPIDATUM ROOT EXTRACT PUERARIA LOBATA ROOT EXTRACT VANILLYL BUTYL ETHER BUTYROSPERMUM PARKII (SHEA BUTTER) CENTELLA ASIATICA EXTRACT PUERARIA MIRIFICA ROOT EXTRACT MENTHOLUM CIMICIFUGA RACEMOSA ROOT EXTRACT PORTULACA OLERACEA EXTRACT LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL

🎯 Purpose 10 words ▾

When applied to the skin, it may help with appearance

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84867-0024-01 · Jiashen 84867-0040-01 · Jiashen →
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.