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FEXOFENADINE HYDROCHLORIDE 30 mg/5mL Suspension — NDC 58602-0427-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FEXOFENADINE HYDROCHLORIDE 30 mg/5mL Suspension — NDC 58602-427-20 (Billing 58602-0427-20)

by Aurohealth LLC · 1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE

This is a package of FEXOFENADINE HYDROCHLORIDE 30 mg/5mL Suspension from Aurohealth LLC, marketed since Aug 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58602-0427-20
🏷️ FDA NDC (as labeled) 58602-427-20 billing pads the product segment with a zero
This package
Contains240 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 58602-427 · Also comes in: 120 mL 58602-427-24
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 58602-427-20 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58602 labeler · 427 product · 20 package
Package marketed since
Aug 31, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5860242720 7
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-427-20
Product NDC 58602-427
11-digit billing NDC 58602042720
RxCUI 997491
UNII 2S068B75ZU
Application # ANDA213466
SPL Set ID fe864426-c0d6-492a-96be-cd44fd9ca054
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-31
Route ORAL
Dosage form SUSPENSION
Substance FEXOFENADINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 997491
Why two NDCs? The FDA registers this code as 58602-427-20 — 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 → 58602-0427-20. 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.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Other antihistamines for systemic use
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Fexofenadine is an antihistamine that relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat caused by hay fever o...
  • The FDA labels for fexofenadine do not list drowsiness as a side effect in the consumer sections provided. That said, everyone responds a little differently, so pay attention to ho...
  • You'll want to be careful here. The label says not to take fexofenadine at the same time as aluminum or magnesium antacids — the kind used for heartburn or upset stomach — and to a...
  • Can I take fexofenadine with my antacids or a glass of orange juice?
📖 Read our full Fexofenadine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 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: 120 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58602-0427-20 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE 2026-08-31 — Active
58602-0427-24 58602-427-24 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE 2026-08-31 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 240 ml in 1 bottle.
What NDC number is used to bill for this package of FEXOFENADINE HYDROCHLORIDE 30 mg/5mL Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fexofenadine Hydrochloride 30 mg/5mL 58602-0426-20 Aurohealth 1 bottle — — FDA listed —
Fexofenadine Hydrochloride 30 mg/5mLthis 58602-0427-20 Aurohealth 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color White
FlavorBerry
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.

🧪 Avoiding an ingredient? See Fexofenadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • 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 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesdibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, raspberry flavor (contains propylene glycol and triacetin), raspberry sweet flavor (contains propylene glycol), sucrose, titanium dioxide, xanthan gum, xylitol. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016

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

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA213466 (ANDA)
Labeler code58602
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio178 products on file

More NDCs from Aurohealth LLC labeler code 58602

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

⏱️ Dosage and Administration 90 words ▾

Directions shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = milliliters

⚠️ Warnings 20 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

📦 Storage and Handling 39 words ▾

Other information each 5 mL contains: phosphorus 15 mg and sodium 18 mg safety sealed: do not use if carton is opened or seal under cap opening is broken or missing store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 13 words ▾

Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg

🧪 Inactive Ingredients 68 words ▾

Inactive ingredients dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, raspberry flavor (contains propylene glycol and triacetin), raspberry sweet flavor (contains propylene glycol), sucrose, titanium dioxide, xanthan gum, xylitol. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Ask a Doctor Before Use If 20 words ▾

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

📄 When Using This Product 30 words ▾

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Package Label / Principal Display Panel 175 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label AUROHEALTH NDC 58602-427-20 Ages 2 Years & Older NON-DROWSY Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine INDOOR / OUTDOOR ALLERGY RELIEF Dosing Cup Included Wash and let air dry after each use 12 HR Raspberry FLAVOR Alcohol & Dye FREE 8 fl. oz. (240 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label AUROHEALTH NDC 58602-427-20 # Compare to the active Ingredient in Children’s Allegra ® Allergy Ages 2 Years & Older Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine 12 HR NON-DROWSY Liquid INDOOR / OUTDOOR ALLERGY RELIEF √ Sneezing √ Runny Nose √ Itchy, Watery Eyes √ Itchy Nose or Throat Use Only With Enclosed Dosing Cup Wash and let air dry after each use Raspberry FLAVOR Alcohol & Dye FREE 8 fl. oz.

(240 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label

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

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 Fexofenadine Hydrochloride (this brand).

Top reported reactions

Nausea464
Fatigue437
Headache433
Diarrhoea429
Dizziness395
Pruritus372
Dyspnoea367

Age at onset

Neonate5
Infant3
Child20
Adolescent47
Adult1,182
Elderly753

Reporter sex

8,737 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization2,496
Death524
Life-threatening379
Disabling348
Reports over time (by year) — tap or hover for the count & year
2025 2026 794 429
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.

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

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 Aurohealth LLC. 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 1 bottle (58602-0427-24). 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?
Aurohealth 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.
← 58602-0426-20 · Aurohealth 58602-0444-09 · Aurohealth →
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.