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12HR Allergy Relief Fexofenadine Hydrochloride 60 mg Tablet, 12-count — NDC 70000-0586-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

12HR Allergy Relief Fexofenadine Hydrochloride 60 mg Tablet, 12-count — NDC 70000-0586-1 (Billing 70000-0586-01)

by CARDINAL HEALTH · 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 12 tablets of 12HR Allergy Relief Fexofenadine Hydrochloride 60 mg Tablet from CARDINAL HEALTH, marketed since Sep 2021 and currently FDA-listed; retail pharmacies pay about $0.1529 per tablet (NADAC). It is this product's only package size.

NDC 70000-0586-01
🏷️ FDA NDC (as labeled) 70000-0586-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 70000-0586-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0586 product · 1 package
Package marketed since
Sep 24, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
12 EA per package
Barcode (UPC)
0096295141474
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0586-1
Product NDC 70000-0586
11-digit billing NDC 70000058601
NCPDP billing unit EA — each (per item)
RxCUI 997501
UNII 2S068B75ZU
UPC 0096295141474
Application # ANDA211075
SPL Set ID ea5d0e55-2191-4094-b082-24b317f95752
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 2021-09-24
Route ORAL
Dosage form TABLET
Substance FEXOFENADINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 41550024100320
GCN Seq No 031689
GCN 46593
HICL code 011595
Ingredient (HICL) Fexofenadine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Q
Therapeutic class — specific (HIC3) Antihistamines - 2Nd Generation
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name ALLERGY RLF (FEXO) 60 MG TAB
FDB brand name Allergy Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 031689
  • GCN: 46593
  • GPI-14 (Medi-Span): 41550024100320
  • HICL (First Databank): 011595
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 997501
Why two NDCs? The FDA registers this code as 70000-0586-1 — a 5-4-1 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 package segment → 70000-0586-01. 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.

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

Label name ALLERGY RLF (FEXO) 60 MG TAB Ingredient Fexofenadine Hcl
📖 What it is MedlinePlus · NLM

Fexofenadine is used to treat allergy symptoms: runny nose sneezing red, itchy, or watering eyes itching of the nose or throat It is also used to treat itching and redness caused by hives. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Read the full MedlinePlus article ↗
📗 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 →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.153 $1.83 / 12 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Jul 2022 Dec 2023 Mar 2026 Sep 2026 $0.187 $0.151
▼ Down 3% over the last 18 months.
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
70000-0586-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2021-09-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
fexofenadine hcl 60 mg 00904-7192-40 Major 500 tablets $0.153 — Availability likely —
Fexofenadine hydrochloride 60 mg 55111-0783-01 Dr. 100 tablets $0.153 — Availability likely —
Fexofenadine hydrochloride 60 mg 68001-0439-00 BluePoint 100 tablets $0.153 — Availability likely —
Fexofenadine HCl 60 mg 69230-0201-05 Camber 500 tablets $0.153 — Availability likely —
12HR Allergy Relief 60 mgthis 70000-0586-01 CARDINAL 12 tablets $0.153 — Availability likely —
Allergy Relief 60 mg 70677-1008-01 Strategic 24 tablets $0.153 — Discontinued —
Allergy Relief 60 mg 83324-0009-12 Chain 12 tablets $0.153 — Availability likely —
Fexofenadine hydrochloride 60 mg 00363-0783-24 Walgreens 24 tablets — — FDA listed —
Fexofenadine HCL 60 mg 00363-9765-24 Walgreens 24 tablets — — FDA listed —
Fexofenadine HCl 60 mg 11822-7652-04 Rite 24 tablets — — FDA listed —
Allergy Relief 60 mg 11822-9995-01 Rite 24 tablets — — Discontinued —
Fexofenadine Hydrochloride 60 mg 30142-0091-12 Kroger 12 tablets — — Discontinued —
Allergy Relief 60 mg 37808-0391-02 HEB 12 tablets — — FDA listed —
Allegra Allergy 60 mg 41167-4131-02 Chattem, 12 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 43598-0936-01 Dr. 100 tablets — — FDA listed —
fexofenadine hcl 60 mg 50228-0201-01 ScieGen 30 tablets — — FDA listed —
Crcle Fexofenadine Hydrochloride 60 mg 57483-0230-01 Innovus 100 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 62207-0765-49 Granules 1000 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 62207-0889-49 Granules 1000 tablets — — FDA listed —
Allergy Relief 60 mg 63548-0663-05 PLD 500 tablets — — FDA listed —
Allergy Relief 60 mg 63868-0819-12 Chain 12 tablets — — Discontinued —
Allergy Relief Non Drowsy 60 mg 69168-0437-06 Allegiant 120 tablets — — FDA listed —
Fexofenadine HCL 60 mg 69230-0301-01 Camber 100 tablets — — FDA listed —
Allergy Relief 60 mg 69842-0492-02 CVS 12 tablets — — FDA listed —
fexofenadine hcl 60 mg 71335-2165-01 Bryant 30 tablets — — FDA listed —
fexofenadine hcl 60 mg 71399-8659-01 AKRON 100 tablets — — FDA listed —
Allergy Relief 60 mg 72036-0191-03 HARRIS 288 tablets — — FDA listed —
Gencare-Allergy Relief 60 mg 72090-0068-01 Pioneer 100 tablets — — FDA listed —
Fexofenadine HCL 60 mg 73581-0010-01 YYBA 10 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 73581-0025-01 YYBA 10 tablets — — FDA listed —
Allergy Relief 60 mg 73581-0103-10 YYBA 100 tablets — — FDA listed —
fexofenadine hcl 60 mg 77771-0201-01 Radha 100 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 84324-0045-01 NUVICARE 60 tablets — — FDA listed —
Fexofenadine Hydrochloride 60 mg 58602-0877-09 Aurohealth 30 tablets — — 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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
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 orange
ShapeOval
ImprintG5
Size12 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

The official label also statescolloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

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

LabelerCARDINAL HEALTH
Application holderGRANULES INDIA LTD
FDA applicationANDA211075 (ANDA)
Labeler code70000
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio84 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.

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 26 words ▾

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

⏱️ Dosage and Administration 56 words ▾

Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

⚠️ Warnings 121 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

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 an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use.

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

📦 Storage and Handling 18 words ▾

Other information store between 20-25°C (68-77°F) protect from excessive moisture retain carton for complete product information and warnings

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Fexofenadine HCl 60 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 19 words ▾

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

📄 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 right away (1-800-222-1222).

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL LEADER™ NDC 70000-0586-1 NON-DROWSY 12 HR Allergy Relief Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine Indoor/Outdoor Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Nose or Throat 12 TABLETS Actual Size COMPARE TO ALLEGRA® 12 HOUR ALLERGY active ingredient* 100% Money Back Guarantee image description

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 12HR Allergy Relief (this brand).

Top reported reactions

Nausea333
Headache325
Diarrhoea324
Fatigue308
Pruritus295
Dizziness279
Dyspnoea265

Reporter sex

5,876 reports

Serious outcomes

Hospitalization1,947
Death406
Life-threatening323
Disabling295
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 449 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.
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.