NDC 50845-0274-01 — Fem Flora Defense Baptisia Tinctoria, Borax

🆔 Identity & classification

FDA NDC (as labeled) 50845-0274-1

Product NDC 50845-0274

11-digit billing NDC 50845027401

UNII 5EF0HWI5WU, 91MBZ8H3QO, 4D7G21HDBC, 0KZ676D44N, S003A158SB, VB06AV5US8 +6 more

UPC 0363113117967

SPL Set ID 8015e1cb-9ebd-4b3e-af57-92f2754fb790

Established class (EPC) Non-Standardized Fungal Allergenic Extract

Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production

Chemical class Fungal Proteins; Allergens

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-04-22

Route ORAL

Dosage form SPRAY

Substance BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA WHOLE; NITRIC ACID; PULSATILLA PRATENSIS WHOLE; RANCID BEEF; SEPIA OFFICINALIS JUICE; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY

Why two NDCs? The FDA registers this code as 50845-0274-1 — 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 → 50845-0274-01. 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

LabelerLiddell Laboratories, Inc.

Labeler code50845

First marketedApr 2021

Product typeHuman Otc Drug

Portfolio52 products on file

🔎 All NDCs from Liddell Laboratories, Inc.

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?

Fem Flora Defense is an unapproved homeopathic oral spray containing multiple plant extracts and minerals used in homeopathic tradition. The formula includes echinacea, thuja, and pulsatilla, which are commonly included in homeopathic preparations, along with candida species and compounds like borax and various acids. According to homeopathic practice, these ingredients are selected to support the body's response to certain conditions, though homeopathic products are not evaluated by the FDA for effectiveness and their use is based on traditional homeopathic principles rather than established medical evidence.

Patient education

📘 MedlinePlus patient leaflet ↗

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 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 20% 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
Fem Flora Defense 3 [hp_X]/mL; 30 [hp_C]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 30 [hp_C]/mL; 3 [hp_X]/mL; 30 [hp_C]/mLthis 50845-0274-01	Liddell	30 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

🏛️

2021

On the market since

Apr 2021

📍

2026

Currently FDA-listed

5 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50845-0274-01 You're viewing this	30 mL in 1 BOTTLE, SPRAY (50845-0274-1)	2021-04-22	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Fem Flora Defense Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Cinchona Officinalis, Echinacea (Angustifolia), Nitricum Acidum, Pulsatilla (Pratensis), Pyrogenium, Sepia, Sulphuricum Acidum, Thuja Occidentalis 3 [hp_X]/mL; 30 [hp_C]/mL; 12 [hp_X]/mL; 8 [hp_C]/mL; 30 [hp_C]/mL; 3 [hp_X]/mL; 30 [hp_C]/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 50845-0274-1, 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: 50845-0274-01, written without dashes as 50845027401. 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 50845-0274-01, the first segment (50845) is the labeler code FDA assigned to Liddell Laboratories, Inc.; the middle segment (0274) 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 Liddell Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Liddell Laboratories, 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.

📄 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 28 words ▾

INDICATIONS: May temporarily relieve symptoms of Candida infections: vaginal discharge, vaginal discomfort, abdominal distention, bloating.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 25 words ▾

DIRECTIONS: Adults and children over 12: Spray twice under the tongue 3 times per day. Children 12 and under: Consult a doctor prior to use.

⚠️ Warnings 58 words ▾

WARNINGS: If symptoms persist for more than 7 days, consult a doctor. If pregnant or breast feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

🧪 Active Ingredient 40 words ▾

ACTIVE INGREDIENTS: (in each spray) 8.33% of Baptisia Tinctoria 3X, Borax 30C, Candida Albicans 12X, Candida Parapsilosis 8C, Cinchona Officinalis 30C, Echinacea (Angustifolia) 3X, Nitricum Acidum 30C, Pulsatilla (Pratensis) 30C, Pyrogenium 200C, Sepia 30C, Sulphuricum Acidum 30C, Thuja Occidentalis 30C.

🧪 Inactive Ingredients 8 words ▾

INACTIVE INGREDIENTS: Organic alcohol 20% v/v, Purified water.

🎯 Purpose 28 words ▾

INDICATIONS: May temporarily relieve symptoms of Candida infections: vaginal discharge, vaginal discomfort, abdominal distention, bloating.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Cinchona Officinalis, Echinacea (Angustifolia), Nitricum Acidum, Pulsatilla (Pratensis), Pyrogenium, Sepia, Sulphuricum Acidum, Thuja Occidentalis NDCsSame ingredient 🏭 All Liddell labeler NDCsLabeler code 50845 📚 All Non-Standardized Fungal Allergenic Extract NDCsDrug class