![Estrogen and Progesterone Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 3 [hp_X]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 3 [hp_X]/mL Spray — NDC 43853-0017-02 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf&name=PBLN05+Estrogen+Progesterone+LBL+12-17-10.jpg)
Estrogen and Progesterone Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 3 [hp_X]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 3 [hp_X]/mL Spray
by ProBLEN · 1 BOTTLE, SPRAY in 1 CARTON (43853-0017-2) / 30 mL in 1 BOTTLE, SPRAY (43853-0017-1)
NDC 43853-0017-02
🏷️ FDA NDC (as labeled)
43853-0017-2
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 17, 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)
43853-0017-2
Product NDC
43853-0017
11-digit billing NDC
43853001702
UNII
433OSF3U8A, B66F4574UG, 7S82P3R43Z, O80TY208ZW, K73E24S6X9, 4TI98Z838E +10 more
SPL Set ID
71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf
Established class (EPC)
Standardized Insect Venom Allergenic Extract; Estrogen; Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract; Progesterone
Mechanism of action
Estrogen Receptor Agonists
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class
Allergens; Bee Venoms; Estradiol Congeners; Dietary Proteins; Plant Proteins; Progesterone
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-01-12
Route
ORAL
Dosage form
SPRAY
Substance
CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; ASIAN GINSENG; SUS SCROFA OVARY; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISC
Why two NDCs?
The FDA registers this code as 43853-0017-2 — a 5-4-1 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 package segment → 43853-0017-02. 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.
🏭 Manufacturer & labeler
LabelerProBLEN
Labeler code43853
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio15 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?
This is an unapproved homeopathic oral spray containing herbal extracts, insect venom, and hormone substances. The product includes ingredients such as black cohosh, chaste tree, angelica, ginseng, and licorice root, which are traditionally used in herbal and homeopathic practice for female reproductive and hormonal support, along with estradiol, estriol, and progesterone. Homeopathic products are marketed based on traditional use rather than FDA evaluation for safety or effectiveness.
Patient education
Supplement & herbal interactions
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 Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album?
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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
-
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.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesOrganic Alcohol 30% v/v, Purified Water
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 mL | 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 |
|---|---|---|---|---|---|---|
| Estrogen and Progesterone 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 3 [hp_X]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 3 [hp_X]/mLthis 43853-0017-02 | ProBLEN | 1 bottle | — | — | 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
🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 years 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.
🔬 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 Estrogen and Progesterone (this brand).
Top reported reactions
Age at onset
Reporter sex
Female · 100%
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 |
|---|---|---|---|
| 43853-0017-02 You're viewing this | 1 BOTTLE, SPRAY in 1 CARTON (43853-0017-2) / 30 mL in 1 BOTTLE, SPRAY (43853-0017-1) | 2017-01-12 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
Estrogen and Progesterone Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 3 [hp_X]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 9 [hp_C]/mL; 3 [hp_X]/mL SPRAY is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.
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 Homeopathic". 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 43853-0017-2, 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: 43853-0017-02, written without dashes as 43853001702. 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 43853-0017-02, the first segment (43853) is the labeler code FDA assigned to ProBLEN; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 ProBLEN. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ProBLEN 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 ▾
INDICATIONS: Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.
⏱️ Dosage and Administration ▾
DIRECTIONS: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.
⚠️ Warnings ▾
WARNINGS: Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.
As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Tamper Evident. There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.
🧪 Active Ingredient ▾
ACTIVE INGREDIENTS: Agnus Castus 3X, Angelica Sinensis 3X, Apis Mellifica 6X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Korean Ginseng 3X, Oophorinum (Suis) 30C, Progesterone 6X, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: Organic Alcohol 30% v/v, Purified Water
🎯 Purpose ▾
INDICATIONS: Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.
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.