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Gembooxt Vaginal Probiotics Gel COPTIS CHINENSIS ROOT .03 g/g; .05 g/g; .03 g/g; .01 g/g Gel — NDC 76986-0021-01 package photo

Gembooxt Vaginal Probiotics Gel COPTIS CHINENSIS ROOT .03 g/g; .05 g/g; .03 g/g; .01 g/g Gel

by Guangdong Quadrant Ecological Technology Co., Ltd. · 12 TUBE in 1 BOX (76986-021-01) / 3 g in 1 TUBE
NDC 76986-0021-01
🏷️ FDA NDC (as labeled) 76986-021-01 billing pads the product segment with a zero
This package
Contains3 g in 1 tube Pack sizes2 compare ↓
Also comes in: 7 tubes 76986-0021-02
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 76986-021-01
Product NDC 76986-021
11-digit billing NDC 76986002101
UNII R57ZHV85D4, CXS4LJR7EL, 5NF60V72O5, P0M7O4Y7YD
UPC 6977863764360
Application # 505G(a)(3)
SPL Set ID 464b0e4a-6d92-9a03-e063-6294a90a6ff4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-19
Route VAGINAL
Dosage form GEL
Substance BORIC ACID; COPTIS CHINENSIS ROOT; CANARIUM ALBUM WHOLE; CALENDULA OFFICINALIS FLOWER
Why two NDCs? The FDA registers this code as 76986-021-01 — 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 → 76986-0021-01. 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

LabelerGuangdong Quadrant Ecological Technology Co., Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code76986
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio35 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?

Gembooxt Vaginal Probiotics Gel is an over-the-counter vaginal gel product marketed under FDA's OTC monograph rules. It contains boric acid, which is typically used as a vaginal antimicrobial agent, along with botanical ingredients including calendula flower, canarium album, and coptis chinensis root that are commonly included in vaginal health products for their traditional supportive properties. This product is applied directly into the vagina as a gel formulation.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 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 B86IS274O0
    A plant extract from safflower flower buds used as a natural colorant and flavoring agent in medicines. It provides color and taste to make the product more appealing.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 2C1F12C6AP
    A beneficial live bacterium used as a probiotic ingredient. It's included to support the product's probiotic function by promoting beneficial microorganisms in the digestive system.
  • UNII 9I70D8O47I
    A plant-derived ingredient from the root of Lithospermum erythrorhizon. It may be used as a natural colorant or preservative in formulations.
  • UNII UC1K4NA7ML
    A natural plant extract from senna seeds that acts as a disintegrant, helping the tablet break apart quickly in the digestive system so the medicine can be absorbed effectively.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 9R6ON4417X
    A plant extract from Stephania japonica used in traditional preparations. It may act as a filler or binding agent to help hold the medicine together and give it proper form and texture.
  • 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.

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

The official label also statesWATER LACTOBACILLUS FERMENT LYSATE SNAKE SEED EXTRACT ALOE VERA EXTRACT QIAN JIN TENG EXTRACT CARTHAMUS TINCTORIUS (SAFFLOWER) EXTRACT LITHOSPERMUM ERYTHRORHIZON EXTRACT COCOS NUCIFERA (COCONUT) OIL TOCOPHERYL ACETATE SQUALANE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL CARBOMER

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 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.
Try another pack size: 7 tubes
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gembooxt Vaginal Probiotics Gel .03 g/g; .05 g/g; .03 g/g; .01 g/gthis 76986-0021-01 Guangdong 12 tubes — — 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

🏛️
2025
On the market since
Dec 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.

🔬 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 COPTIS CHINENSIS ROOT — the ingredient across all brands.

Top reported reactions

Drug Interaction1
Gynaecomastia1
Herbal Interaction1

Age at onset

Adult1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
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 NDCDescription Marketing startStatus
76986-0021-01 You're viewing this 12 TUBE in 1 BOX (76986-021-01) / 3 g in 1 TUBE 2025-12-19 Active
76986-0021-02 7 TUBE in 1 BOX (76986-021-02) / 3 g in 1 TUBE 2025-12-19 Active

Pack size FAQ

What quantity is in NDC 76986-0021-01?
NDC 76986-0021-01 is listed by the FDA — 12 tube in 1 box / 3 g in 1 tube.
What NDC number is used to bill for this package of Gembooxt Vaginal Probiotics Gel COPTIS CHINENSIS ROOT .03 g/g; .05 g/g; .03 g/g; .01 g/g Gel?
Bill NDC 76986-0021-01 — the 11-digit billing format is 76986002101. 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
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 "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.
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 76986-021-01, 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: 76986-0021-01, written without dashes as 76986002101. 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 76986-0021-01, the first segment (76986) is the labeler code FDA assigned to Guangdong Quadrant Ecological Technology Co., Ltd.; the middle segment (0021) 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 Guangdong Quadrant Ecological Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 7 tubes (76986-0021-02). 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?
Guangdong Quadrant Ecological Technology 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 24 words ▾

To mitigate symptoms associated with known bacterial vaginosis infections, such as a pungent odor, excessive discharge, as well as discomfort and burning during urination.

⏱️ Dosage and Administration 77 words ▾

Adults and children 12 years and older: 1.Thoroughly wash your hands and the external vaginal area. 2.Remove the bottom cover and the top cap. 3.Attach the top cap to the base.

4.Press plunger gently. 5.Lie on your back with your knees bent. Gently insert the applicator into the vagina and press plunger fully to release the gel.

6.Withdraw and discard the applicator. 7.Use one applicatorful daily, preferably at bedtime. Children under 12 years: Consult a health professional

⚠️ Warnings 4 words ▾

For vaginal use only.

🧪 Active Ingredient 15 words ▾

COPTIS CHINENSIS EXTRACT 5% CANARIUM ALBUM EXTRACT 3% BORIC ACID 3 CALENDULA OFFICINALIS EXTRACT 1%

🧪 Inactive Ingredients 34 words ▾

WATER LACTOBACILLUS FERMENT LYSATE SNAKE SEED EXTRACT ALOE VERA EXTRACT QIAN JIN TENG EXTRACT CARTHAMUS TINCTORIUS (SAFFLOWER) EXTRACT LITHOSPERMUM ERYTHRORHIZON EXTRACT COCOS NUCIFERA (COCONUT) OIL TOCOPHERYL ACETATE SQUALANE SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL CARBOMER

🎯 Purpose 1 words ▾

Antimicrobial

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.