Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg Film, Soluble
by Guangzhou Yixin Cross-border E-commerce Co., Ltd. · 8 PATCH in 1 BOX (84778-090-04) / 60 mg in 1 PATCH
NDC 84778-0090-04
🏷️ FDA NDC (as labeled)
84778-090-04
billing pads the product segment with a zero
This package
Contains60 mg in 1 patch
Pack sizes4 compare ↓
OTC
Discontinued
Non-controlled
⚠ Inactivated by FDA
🗂️ Data synced Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
84778-090-04
Product NDC
84778-090
11-digit billing NDC
84778009004
UNII
742SXX0ICT, UCE6F4125H
Application #
505G(a)(3)
SPL Set ID
3f809919-12de-7f16-e063-6294a90aae6f
Established class (EPC)
Phosphodiesterase 5 Inhibitor
Mechanism of action
Phosphodiesterase 5 Inhibitors
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Inactivated by FDA (certified through Dec 2026)
Marketing start
2025-08-24
Route
TOPICAL
Dosage form
FILM, SOLUBLE
Substance
TADALAFIL; VARDENAFIL
Why two NDCs?
The FDA registers this code as 84778-090-04 — 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 → 84778-0090-04. 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
LabelerGuangzhou Yixin Cross-border E-commerce Co., Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code84778
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio29 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?
Esokalli Testosterone Booster is an over-the-counter oral dissolving film containing tadalafil and vardenafil. Both active ingredients belong to a class of medicines called phosphodiesterase 5 inhibitors, which are typically used to address certain types of sexual dysfunction in men. The film dissolves in the mouth for systemic absorption. This product is marketed under the FDA's OTC monograph rules for its category.
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 Esokalli Testosterone Booster Oral Dissolving Film?
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 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
-
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesFilm-forming polymers, stabilizers, sweeteners, flavoring agents.
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 each | 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
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 |
|---|---|---|---|---|---|---|
| Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg 84778-0093-01 | Guangzhou | 1 patch | — | — | Discontinued | — |
| Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mgthis 84778-0090-04 | Guangzhou | 8 patches | — | — | Discontinued | — |
| Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg 84778-0085-01 | Guangzhou | 1 patch | — | — | Discontinued | — |
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
Aug 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84778-0090-01 | 1 PATCH in 1 BOX (84778-090-01) / 60 mg in 1 PATCH | 2025-08-24 | Inactivated by FDA |
| 84778-0090-02 | 2 PATCH in 1 BOX (84778-090-02) / 60 mg in 1 PATCH | 2025-08-24 | Inactivated by FDA |
| 84778-0090-03 | 4 PATCH in 1 BOX (84778-090-03) / 60 mg in 1 PATCH | 2025-08-24 | Inactivated by FDA |
| 84778-0090-04 You're viewing this | 8 PATCH in 1 BOX (84778-090-04) / 60 mg in 1 PATCH | 2025-08-24 | Inactivated by FDA |
Pack size FAQ
What quantity is in NDC 84778-0090-04?
NDC 84778-0090-04 is listed by the FDA — 8 patch in 1 box / 60 mg in 1 patch.
What NDC number is used to bill for this package of Esokalli Testosterone Booster Oral Dissolving Film 40 mg/100mg; 20 mg/100mg Film, Soluble?
Bill NDC 84778-0090-04 — the 11-digit billing format is 84778009004. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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 | — Not published for this NDC No photo available yet for this listing. |
| 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 "Otc Monograph Drug". 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 84778-090-04, 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: 84778-0090-04, written without dashes as 84778009004. 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 84778-0090-04, the first segment (84778) is the labeler code FDA assigned to Guangzhou Yixin Cross-border E-commerce Co., Ltd.; the middle segment (0090) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 patch (84778-0090-01), 2 patches (84778-0090-02), 4 patches (84778-0090-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Guangzhou Yixin Cross-border E-commerce Co., Ltd. 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 ▾
Uses For the treatment of erectile dysfunction (ED)
⏱️ Dosage and Administration ▾
Dosage and Administration • Take 1 oral film as a single dose. • Administer orally by placing on the tongue until dissolved. • Administer approximately 0.5 to 4 hours prior to anticipated sexual activity. • Do not exceed 1 dose in 24 hours.
⚠️ Warnings ▾
Warnings For adult men only.
🧪 Inactive Ingredients ▾
Inactive ingredients Film-forming polymers, stabilizers, sweeteners, flavoring agents.
🎯 Purpose ▾
Purpose Phosphodiesterase type 5 (PDE5) inhibitors
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.