ALORYXA GYNECOLOGICAL INTIMATE CARE Gel .1 g/100g; .02 g/100g; .01 g/100g Gel — NDC 87854-0001-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ALORYXA GYNECOLOGICAL INTIMATE CARE Gel .1 g/100g; .02 g/100g; .01 g/100g Gel — NDC 87854-001-02 (Billing 87854-0001-02)

by Tupelo Brittany LLC · 7 VIAL in 1 BOX / 3 g in 1 VIAL

This is a package of ALORYXA GYNECOLOGICAL INTIMATE CARE Gel .1 g/100g; .02 g/100g; .01 g/100g Gel from Tupelo Brittany LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 87854-0001-02
🏷️ FDA NDC (as labeled) 87854-001-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 87854-001-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87854 labeler · 001 product · 02 package
Package marketed since
Jul 22, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8785400102 6
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87854-001-02
Product NDC 87854-001
11-digit billing NDC 87854000102
UNII 85H0HZU99M, I8442U2G7J, BQM438CTEL
SPL Set ID 57346a86-ab51-021a-e063-6394a90a1dc2
Established class (EPC) Antiseptic
Chemical class Iodine
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-22
Route TOPICAL
Dosage form GEL
Substance POVIDONE-IODINE; PORK COLLAGEN; EPIGALLOCATECHIN GALLATE
Why two NDCs? The FDA registers this code as 87854-001-02 — 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 → 87854-0001-02. 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.

Clinical

🧪 What is this product?

Aloryxa Gynecological Intimate Care is a topical gel applied to intimate areas. It contains povidone-iodine, which is commonly used for its antimicrobial properties in wound care and skin cleansing. The gel also includes pork collagen and epigallocatechin gallate (a compound found in green tea), which are typically used in skincare products for their moisturizing and antioxidant properties. This product is marketed as an unapproved drug and has not received FDA approval.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87854-0001-02 You're viewing this Main listing 7 VIAL in 1 BOX / 3 g in 1 VIAL 2026-07-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aloryxa .1 g/100g; .02 g/100g; .01 g/100gthis 87854-0001-02 Tupelo 7 vials — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

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 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 LJG642C0AI
    A plant extract from Arnebia euchroma used as a natural colorant and skin-conditioning agent in topical formulations. It provides color and may help maintain skin texture in creams, lotions, and similar products.
  • UNII IJI7YZ55VS
    A dried whole plant material from Astragalus mongholicus, a plant used in traditional medicine. It may serve as a filler or natural ingredient to add bulk and botanical content to 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII JK0MS9P8YL
    Cnidium monnieri fruit oil is a plant-derived oil extracted from the fruit of Cnidium monnieri (Chinese motherwort). In medicines, it serves as a fragrance component, skin conditioning agent, or delivery vehicle to improve product stability and absorption.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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 3297VXM8Z6
    A plant-derived humectant and emollient made from glycerin and glucose. It helps retain moisture in the formulation and improves texture and spreadability in topical products.
  • UNII 8XW1DS8UIR
    A plant extract from licorice root, used as a natural sweetener, flavoring agent, and to help soothe and coat the throat or digestive tract in some formulations.
  • UNII OZU2FC70HY
    Hypericum oil is a plant-derived oil made from St. John's wort flowers. It's used in medicines as an emollient and skin-conditioning agent to soften and protect the skin or mucous membranes.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Q48HGS34EC
    A plant-derived ingredient from the rheum tanguticum root, used as a natural colorant and potentially as a mild binding or texturing agent in solid dosage forms.
  • UNII 1693AM5SBN
    Salvia miltiorrhiza root is a plant extract used in traditional medicine formulations. It may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended therapeutic profile.
  • UNII 7F763NNC9X
    Schizophyllan is a polysaccharide derived from a fungus. It's used as a binder and thickening agent to help hold tablet ingredients together and improve the texture of medicines.
  • UNII 6YF0M477I5
    A plant extract from the baicalensis skullcap plant, traditionally used in herbal medicine. In formulations, it may serve as an active botanical ingredient or functional additive rather than a typical inactive binder or filler.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII RDS2V6DVY5
    A plant extract from grape seeds that contains natural compounds. Used in supplements and medicines as an antioxidant ingredient and to support product stability.
  • 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.

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

The official label also statesPurified Water (Aqua), Glycerin, Carbomer, Propylene Glycol, Butylene Glycol, Triethanolamine, 1,2-Hexanediol, Glyceryl Glucoside, Beta-Glucan of SchizophyllumCommune, Salvia Miltiorrhiza Root Extract, Curcuma Longa Root Extract, VitisVinifera Seed Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Extract,Rheum Tanguticum Root Extract, Scutellaria Baicalensis Extract, AstragalusMembranaceus Mongholicus Extract, Hypericum Perforatum Extract, Centella Asiatica Extract, Arnebia Euchroma Extract, Glycyrrhiza Uralensis (Licorice) Extract

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.

Manufacturer & labeler

LabelerTupelo Brittany LLC
Labeler code87854
First marketedJul 2026
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.

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 27 words ▾

Use 1.Reduce vaginal microorganisms that may cause odor, discomfort, or imbalance 2.Provides gentle intimate care and temporary relief of mild irritation. 3.For intravaginal and external topical use.

⏱️ Dosage and Administration 22 words ▾

Directions After washing your hands, open the package, remove the cap, and applyit to the intimate area. Discard applicator after one application.

⚠️ Warnings 7 words ▾

Warnings For external and intravaginal use only

📦 Storage and Handling 22 words ▾

Other information Avoid freezing Protect from direct sunlight and excessive heat above 40°C (104°F) Expiration date / lot number printed on packaging

🧪 Active Ingredient 13 words ▾

Active Ingredient(s) Povidone-lodine 0.1% (w/w). Collagen Porcine 0.02% (w/w). Epigallocatechin Gallate 0.01% (w/w)

🧪 Inactive Ingredients 58 words ▾

Inactive ingredients Purified Water (Aqua), Glycerin, Carbomer, Propylene Glycol, Butylene Glycol, Triethanolamine, 1,2-Hexanediol, Glyceryl Glucoside, Beta-Glucan of SchizophyllumCommune, Salvia Miltiorrhiza Root Extract, Curcuma Longa Root Extract, VitisVinifera Seed Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Extract,Rheum Tanguticum Root Extract, Scutellaria Baicalensis Extract, AstragalusMembranaceus Mongholicus Extract, Hypericum Perforatum Extract, Centella Asiatica Extract, Arnebia Euchroma Extract, Glycyrrhiza Uralensis (Licorice) Extract

🎯 Purpose 8 words ▾

Purpose Antiseptic / Antimicrobial Skin Protectant Skin Protectant

📄 Do Not Use 32 words ▾

Do not use 1. if you are pregnant or in gestational periods 2. on scars, eczema, or dermatitis 3. if you have a known allergy to Benzalkonium Bromide or any listed ingredients

📄 When Using This Product 37 words ▾

1. After opening the cap, use the product immediately and do not reuse it. 2. avoid contact with eyes; if contact occurs, rinse thoroughly with water 3. mild temporary tingling may occur 2. do not share applicators

📄 Stop Use and Ask a Doctor If 26 words ▾

1. irritation, rash, red spot or discomfort occurs . 2.abnormal discharge, fever, pelvic pain, or foul odor develops (may be signs ofanother condition requiring medical attention)

📄 Keep Out of Reach of Children 12 words ▾

If swallowed, get medical help or contact a Poison Control Center Immediately.

📄 Package Label / Principal Display Panel 2 words ▾

label 2

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Tupelo Brittany LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Tupelo Brittany 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.
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.