TexaClear Texas Allergy Relief plus Cedar Fever Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_ Solution/ Drops, 118 mL — NDC 58809-0214-04 package photo

TexaClear Texas Allergy Relief plus Cedar Fever Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_ Solution/ Drops, 118 mL

by GM Pharmaceuticals, INC · 118 mL in 1 BOTTLE, DROPPER (58809-214-04)
NDC 58809-0214-04
🏷️ FDA NDC (as labeled) 58809-214-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes3 compare ↓
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 58809-214-04
Product NDC 58809-214
11-digit billing NDC 58809021404
UNII DO87T1U2CI, 6EIJ3D04MR, 8KDG09A4GO, 89BAT511BD, M3S672G75O, 07A108ZKW5 +12 more
UPC 0358809214013
SPL Set ID 0a5d6aa5-e998-e028-e063-6294a90afde6
Established class (EPC) Non-Standardized Pollen Allergenic Extract; Standardized Pollen Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Pollen; Allergens
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-10
Route SUBLINGUAL
Dosage form SOLUTION/ DROPS
Substance PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN; HOLCUS LANATUS PO
Why two NDCs? The FDA registers this code as 58809-214-04 — 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 → 58809-0214-04. 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

LabelerGM Pharmaceuticals, INC
Labeler code58809
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio17 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?

TexaClear is a homeopathic sublingual solution containing herbal extracts and pollen allergens. According to homeopathic tradition, the herbal ingredients like baptisia, echinacea, and hydrastis are used to support immune function, while the plant pollens from grasses, trees, and weeds are used in homeopathic allergy relief formulations. Homeopathic products are marketed based on traditional homeopathic principles and are not evaluated by the FDA for safety or effectiveness.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer 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: 30 ml 60 ml
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
TexaClear Texas Allergy Relief plus Cedar Fever 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_this 58809-0214-04 GM 118 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

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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 NDCDescription Marketing startStatus
58809-0214-01 30 mL in 1 BOTTLE, DROPPER (58809-214-01) 2023-11-10 Active
58809-0214-02 60 mL in 1 BOTTLE, DROPPER (58809-214-02) 2023-11-10 Active
58809-0214-04 You're viewing this 118 mL in 1 BOTTLE, DROPPER (58809-214-04) 2023-11-10 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 58809-0214-04?
NDC 58809-0214-04 contains 118 mL — 118 ml in 1 bottle, dropper.
What is the difference between NDC 58809-0214-04 and NDC 58809-0214-01?
Both are TexaClear Texas Allergy Relief plus Cedar Fever Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_ Solution/ Drops — the drug itself is identical. NDC 58809-0214-04 is the 118 mL package, while NDC 58809-0214-01 is the 30 ml package.
What NDC number is used to bill for this package of TexaClear Texas Allergy Relief plus Cedar Fever Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_ Solution/ Drops?
Bill NDC 58809-0214-04 — the 11-digit billing format is 58809021404. 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 Homeopathic listing

About homeopathic listings

TexaClear Texas Allergy Relief plus Cedar Fever Antigens All Zones Grasses Trees and Weeds. Baptisia tinctoria, Echinacea, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Urtica urens 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_X]/mL; 6 [hp_ SOLUTION/ DROPS 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 58809-214-04, 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: 58809-0214-04, written without dashes as 58809021404. 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 58809-0214-04, the first segment (58809) is the labeler code FDA assigned to GM Pharmaceuticals, INC; the middle segment (0214) 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.
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 GM Pharmaceuticals, INC. 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 2 other package presentations of this same product, including 30 ml (58809-0214-01), 60 ml (58809-0214-02). 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?
GM Pharmaceuticals, 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 19 words

Uses This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*

⏱️ Dosage and Administration 38 words

Directions Measure only with enclosed dropper provided. Adults 12 years and older: 10-15 drops, 3 times per day, hold under the tongue for at least 30 seconds before swallowing. Consult a doctor for use in children under 12

⚠️ Warnings 41 words

Warnings Use only as directed. For oral (sublingual use). Stop use and ask a doctor if symptoms worsen or do not improve after 7 days. If pregnant or breast-feeding, consult a health professional before use. Keep out of reach of children.

🧪 Active Ingredient 41 words

Active ingredients Antigens 6X, 12X, 30X: **All Zones Grasses, Trees, and Weeds; Herbal Drainage Remedies: Baptisia tinctoria 5X HPUS, Echinacea 5X HPUS, Hydrastis canadensis 5X HPUS, Myrrha 5X HPUS, Nasturtium aquaticum 5X HPUS, Phytolacca decandra 5X HPUS, Urtica urens 5X HPUS

🧪 Inactive Ingredients 7 words

Inactive ingredients ethanol, purified water, vegetable glycerin

🎯 Purpose 11 words

Purpose Relief from sneezing, runny nose, itchy eyes and sinus congestion.*

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.