NDC 83230-0001-01 — Dr Dale Wellness NU Fem 1 2 3 All In One

🆔 Identity & classification

FDA NDC (as labeled) 83230-001-01

Product NDC 83230-001

11-digit billing NDC 83230000101

UNII 459AG36T1B, WI4X0X7BPJ, 398IYQ16YV, NQX9KB6PCL, DK7PL4F3TT, 95067D43FQ +12 more

SPL Set ID 7679472c-bc6a-40c1-8e66-adc0b6ca18b4

Established class (EPC) Corticosteroid; Recombinant Human Growth Hormone; Non-Standardized Food Allergenic Extract; Estrogen; Progesterone; Androgen

Mechanism of action Corticosteroid Hormone Receptor Agonists; Estrogen Receptor Agonists; Androgen Receptor Agonists

Physiologic effect Increased Histamine Release; Cell-mediated Immunity

Chemical class Human Growth Hormone; Allergens; Dietary Proteins; Estradiol Congeners; Progesterone; Androstanes

DEA schedule CIII

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-04-01

Route TOPICAL

Dosage form GEL

Substance PRASTERONE; HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SOMATROPIN; INSULIN-LIKE GROWTH FACTOR 1 RECEPTOR; INSULIN-LIKE GROWTH FACTOR-2; BOS TAURUS HYPOTHALAMUS; HUMAN PLACENTAL TISSUE; BEEF LIVER; BOS TAURUS THYMUS; RNA-BINDING PROTEIN 10; APRINOCARSEN; ES

Why two NDCs? The FDA registers this code as 83230-001-01 — 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 → 83230-0001-01. 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

LabelerDMD Clinical Naturopathy

Labeler code83230

First marketedApr 2024

DEA scheduleCIII

Product typeHuman Otc Drug

🔎 All NDCs from DMD Clinical Naturopathy

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 topical homeopathic gel containing multiple ingredients traditionally used in homeopathic practice, including estrogen compounds, bovine glandular extracts (from pituitary, ovary, thymus, and other tissues), black cohosh, and amino acids like arginine. In homeopathic tradition, these substances are used to address concerns related to female hormonal balance and menopause symptoms, though homeopathic products are marketed based on homeopathic theory rather than FDA evaluation of effectiveness. This product has not been evaluated by the FDA for safety or efficacy.

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 8Z5ZAL5H3V
A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
UNII 7E889U5RNN
A plant material derived from greater celandine, used as a natural extract or botanical ingredient. It may function as a colorant, flavoring agent, or contribute to the overall formulation's botanical composition.
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
UNII 147D247K3P
Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
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.

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

The official label also statesAloe vera leaf juice extract, Benzyl Alcohol, Tocopherol, Acrylates C10-30 Alkyl Acrylate crosspolymer, Disodium EDTA, Sodium hydroxide, water, ethylhexylglycerin, chelidonium majus whole

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 g	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
Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic 1 [hp_X]/50mL; 6 [hp_X]/50mL; 1 [hp_X]/50mL; 1 [hp_M]/50mL; 1 RECEPTOR 6 [hp_X]/50mL; 6 [hp_X]/50mL; 6 [hp_X]/50mthis 83230-0001-01	DMD	50 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

🏛️

2024

On the market since

Apr 2024

📍

2026

Currently FDA-listed

2 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
83230-0001-01 You're viewing this	50 mL in 1 JAR (83230-001-01)	2024-04-01	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic DHEA,Adrenal Cortisol,Glandula Suprarenalis suis,Human Growth Hormone,IGF-I,IGF-II ,Hypothalamus,Pituitary,Placenta,Liver,Thymus,RNA,DNA,Estrogenium,Estradiolinum,Sanguinara Candensis,Oophorinum,Progesteronium,Pitituarinum,Pineal,Folliculinum,Ovarinum,Che 1 [hp_X]/50mL; 6 [hp_X]/50mL; 1 [hp_X]/50mL; 1 [hp_M]/50mL; 1 RECEPTOR 6 [hp_X]/50mL; 6 [hp_X]/50mL; 6 [hp_X]/50m GEL 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 83230-001-01, 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: 83230-0001-01, written without dashes as 83230000101. 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 83230-0001-01, the first segment (83230) is the labeler code FDA assigned to DMD Clinical Naturopathy; the middle segment (0001) 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 DMD Clinical Naturopathy. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

DMD Clinical Naturopathy 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 6 words ▾

Uses Topical gel, applied to skin

⏱️ Dosage and Administration 25 words ▾

Directions Apply 1-2 pumps M-F only to the inner parts of forearm or upper arm on clean skin. Once symptoms recede, you may reduce usage.

⚠️ Warnings 10 words ▾

Warnings No caffeine may be used while on this remedy.

🧪 Active Ingredient 149 words ▾

Active Ingredient (s) DHEA 1X, 2X, 6X, 8X Adrenal Cortisol 6X, 8X, 30X, 3LM Glandula suprarenalis suis 1X, 2X, 3X, 6X, 3LM Human Growth Hormone 30C, 1LM, 3LM, IGF-I, 6X, 12X, 30X, IGF-II, 6X, 12X, 30X Hypothalamus 6X, 15X, 30C, 1LM Pituitary 6X, 15X, 30X, 1LM Placenta 6X, 12X, 30X Liver 6X, 30C Thymus 6X, 30C RNA 6X, 12X 30X DNA 6X, 12X, 30X. Estrogenium 6x Estradiolinum 6x Sanguinara Candensis 3x Oophorinum 3x Progesteronium 3x Pituitarinum 3x Pineal 6x Folliculinum 3x Ovarinum 6x Sulphur 6x Cheladonium 6x Sepia 6x L’argenine 6x Pregnenalone 6x Testosterone 6x RNA 6x (veggie source) DNA 6x (veggie source) Cimicifuga Racemosa (Black Snake-root), 200C Lilium Tigrinum (Tiger-lily), 1M Sulphur (Sublimated Sulphur), 1M Graphites (Black Lead), 1M Kali Phosphoricum (Phosphate of Potassium), 1M Causticum (Hahnemann's tinctura acris sine Kali), 1M Calcarea Carbonica (Carbonate of Lime), 1M Phytolacca (Poke-root), 3x Drainage Scrophularia Nodosa (Knotted Figwort), 3x Drainage

🧪 Inactive Ingredients 25 words ▾

Inactive Ingredients Aloe vera leaf juice extract, Benzyl Alcohol, Tocopherol, Acrylates C10-30 Alkyl Acrylate crosspolymer, Disodium EDTA, Sodium hydroxide, water, ethylhexylglycerin , chelidonium majus whole

🎯 Purpose 12 words ▾

Purpose For uncomfortable symptoms associated with menstrual cycle stopping due to age.

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

🔗 Related NDC lookups

🧪 All Dhea,Adrenal Cortisol,Glandula Suprarenalis Suis,Human Growth Hormone,Igf-I,Igf-Ii ,Hypothalamus,Pituitary,Placenta,Liver,Thymus,Rna,Dna,Estrogenium,Estradiolinum,Sanguinara Candensis,Oophorinum,Progesteronium,Pitituarinum,Pineal,Folliculinum,Ovarinum,Che NDCsSame ingredient 🏭 All DMD labeler NDCsLabeler code 83230 📚 All Androgen NDCsDrug class