HomeNDC LookupIngredientsMultivitamin › 59088-0191-54
Inflamex Multivitamin 5 mg; 25 mg; 10 mg; 100 mg; 1700 ug Capsule, 30-count — NDC 59088-0191-54 package photo

Inflamex Multivitamin 5 mg; 25 mg; 10 mg; 100 mg; 1700 ug Capsule, 30-count

by PureTek Corporation · 30 CAPSULE in 1 BOTTLE (59088-191-54)
NDC 59088-0191-54
🏷️ FDA NDC (as labeled) 59088-191-54 billing pads the product segment with a zero
Rx only 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) 59088-191-54
Product NDC 59088-191
11-digit billing NDC 59088019154
NCPDP billing unit EA — each (per item)
UNII KM66971LVF, 25X51I8RD4, V1V998DC17, 856YO1Z64F, A9R10K3F2F
SPL Set ID 1859a102-9152-018d-e063-6394a90a925f
Established class (EPC) Non-Standardized Food Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Vegetable Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-12
Route ORAL
Dosage form CAPSULE
Substance BLACK PEPPER; NIACINAMIDE; GARLIC; TURMERIC; LEVOMEFOLATE CALCIUM
GPI-14 78500000000100
GCN Seq No 086331
GCN 56028
HICL code 049760
Ingredient (HICL) B3/Lmfol/Turm/Blk Pep/Garl/Hrb
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C5
Therapeutic class — intermediate (HIC2) Carbohydrates And/Or Proteins
HIC3 code C5F
Therapeutic class — specific (HIC3) Dietary Supplement, Miscellaneous
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name INFLAMEX CAPSULE
FDB brand name Inflamex
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 59088-191-54 — 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 → 59088-0191-54. 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

LabelerPureTek Corporation
Labeler code59088
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio178 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

Label name INFLAMEX CAPSULE Ingredient B3/Lmfol/Turm/Blk Pep/Garl/Hrb
🧪 What is this product?

Inflamex is an oral capsule containing a combination of vitamins and plant extracts. The capsule includes levomefolate calcium (a form of folate used in nutritional supplements) and niacinamide (a B vitamin), along with black pepper, garlic, and turmeric, which are plant ingredients commonly included in dietary supplements. This is an unapproved drug product marketed without an FDA-approved application.

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.

💊 What it looks like

Color orange
ShapeCapsule
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 7593U09I4D
    Gellan gum is a thickener made from fermented bacteria. It's used to give medicines a gel-like texture and help them stay stable, especially in liquids and suspensions.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 4DGK8B7I3S
    A starch extracted from rice grains. It acts as a filler to add bulk to the tablet or capsule and as a disintegrant to help the medicine break apart and release its active ingredient in your body.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 eachPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Inflamex 5 mg/1; 25 mg/1; 10 mg/1; 100 mg/1; 1700 ugthis 59088-0191-54 PureTek 30 capsules 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
Jun 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.

🔬 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 Multivitamin — the ingredient across all brands.

Top reported reactions

Fatigue3,699
Nausea3,255
Diarrhoea2,832
Headache2,610
Dizziness2,311
Dyspnoea2,048
Pain1,942

Age at onset

Neonate4
Infant15
Child51
Adolescent38
Adult1,015
Elderly1,062

Reporter sex

49,839 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization11,832
Death2,333
Disabling2,043
Life-threatening1,180
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,407 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
59088-0191-54 You're viewing this 30 CAPSULE in 1 BOTTLE (59088-191-54) 2024-06-12 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 FDA registers it as 59088-191-54, 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: 59088-0191-54, written without dashes as 59088019154. 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 59088-0191-54, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0191) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (54) 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
⏱️ Dosage and Administration 27 words

Dosage and Administration: One (1) lnflamex ™ capsule daily or as directed by a licensed healthcare practitioner. Do not administer to children under the age of 12.

Contraindications 86 words

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. lnflamex™ is contraindicated in patients with gastrointestinal conditions, such as gastric ulcers or gastroesophageal reflux disease (GERD), as they may experience irritation or worsening of symptoms due to the presence of ingredients like garlic and black pepper. Patients with blood clotting disorders or who are on anticoagulant therapy should use caution when consuming high doses of ingredients like garlic, turmeric, and black pepper, as they may have mild blood-thinning effects.

⚠️ Warnings 135 words

Warnings: Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor.

Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Precautions: Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folate to patients with undiagnosed anemia since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

This may result in severe nervous system damage before the correct diagnosis is made. The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

🤒 Adverse Reactions 123 words

Adverse Reactions: Allergic reactions to any of the ingredients can occur, ranging from mild skin irritation to severe anaphylaxis in rare cases. Allergic sensitization has been reported following both oral and parenteral administration of folate. Niacinamide, a form of niacin, may cause flushing, itching, and tingling sensations in some individuals, particularly when taken in higher doses.

This effect is usually harmless but can be uncomfortable. Some individuals may experience gastrointestinal symptoms such as nausea, bloating, or diarrhea, especially when consuming higher doses of certain ingredients like garlic and black pepper. Certain ingredients in the product, such as garlic and black pepper, may interact with medications.

Garlic may potentiate the effects of anticoagulant medications, while black pepper may affect the metabolism of certain drugs.

🤰 Pregnancy 52 words

Pregnancy and Lactation: Not recommended for use during pregnancy or lactation without consulting with a healthcare professional. For use on the order of a licensed healthcare practitioner. If a patient experiences any side effects, call your doctor. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📦 How Supplied / Storage and Handling 38 words

How Supplied: lnflamex™ are light orange powder with black specks, in vegan hard shell capsules. One bottle contains 30 capsules (NDC 59088-191-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

📦 Storage and Handling 33 words

Storage: Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 82 words

DESCRIPTION: lnflamex™ is a unique formulation of selected natural ingredients such as Turmeric, Black Pepper, Garlic and Proprietary Extract Blend combined with Niacin and Folate. This potent blend is designed to support your body's response to inflammation and its natural healing processes. Each capsule contains: Niacin (as Niacinamide) ....……………………………….…......25 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ..........1700 mcg DFE (1000 mcg of L-5-Methylfolate) Turmeric Root Extract……………………………….…………100 mg Garlic Bulb Extract……………………………….……………..

10 mg Pepper Seed Extract……………………………….…………….. 5 mg Proprietary Extract Blend ………………………….…………. 400 mg

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.