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Loratadine 5 mg/5mL Solution, 120 mL — NDC 54838-0554-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Loratadine 5 mg/5mL Solution, 120 mL — NDC 54838-554-40 (Billing 54838-0554-40)

by Lannett Company, Inc. · 120 mL in 1 CARTON

This is a package of 120 mL of Loratadine 5 mg/5mL Solution from Lannett Company, Inc., marketed since Nov 2010 and currently FDA-listed. It is this product's only package size.

NDC 54838-0554-40
🏷️ FDA NDC (as labeled) 54838-554-40 billing pads the product 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 →

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 54838-554-40 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54838 labeler · 554 product · 40 package
Package marketed since
Nov 24, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
120 mL per package
Barcode (UPC)
0354838552409
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54838-554-40
Product NDC 54838-554
11-digit billing NDC 54838055440
NCPDP billing unit ML — per mL (volume)
RxCUI 692783
UNII 7AJO3BO7QN
UPC 0354838552409
Application # ANDA077421
SPL Set ID 069c4e75-1f9f-4ab5-9570-3d93d12c2a23
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-11-24
Route ORAL
Dosage form SOLUTION
Substance LORATADINE

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

GCN Seq No 018697
GCN 60562
HICL code 007605
Ingredient (HICL) Loratadine
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 LORATADINE HIVES 5 MG/5 ML
FDB brand name Loratadine Hives Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 018697
  • GCN: 60562
  • HICL (First Databank): 007605
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 692783
Why two NDCs? The FDA registers this code as 54838-554-40 — 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 → 54838-0554-40. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use
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 LORATADINE HIVES 5 MG/5 ML Ingredient Loratadine
📖 What it is MedlinePlus · NLM

Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves symptoms of hay fever and other upper respiratory allergies. That means runny nose, sneezing, itchy, watery eyes, and an itchy nose or throat.
  • It is taken by mouth, generally once a day. Follow the directions on your specific product. Chewable tablets should be chewed or crushed completely, and liquids should be measured...
  • No. Do not take more than directed. Taking more than directed may cause drowsiness. If you think you took too much, get medical help or call Poison Control right away.
  • Can I take extra if my allergies are bad?
📖 Read our full Loratadine 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 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.
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
54838-0554-40 You're viewing this Main listing 120 mL in 1 CARTON 2010-11-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense childrens allergy relief 5 mg/5mL 00113-0671-26 L. 1 bottle $0.041 — Availability likely —
Childrens Loratadine Oral 5 mg/5mL 00904-6767-20 Major 1 bottle $0.041 — Availability likely —
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0531-26 AmerisourceBergen 1 bottle $0.041 — Availability likely —
good neighbor pharmacy childrens loratadine 5 mg/5mL 46122-0787-34 Amerisource 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 54838-0558-40 Lannett 120 ml $0.041 — Availability likely —
Loratadine 5 mg/5mL 68001-0449-98 BluePoint 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 69230-0322-12 Camber 1 bottle $0.041 — Availability likely —
leader childrens allergy relief 5 mg/5mL 70000-0473-01 Cardinal 1 bottle $0.041 — Availability likely —
Loratadine 5 mg/5mL 70677-1057-01 STRATEGIC 1 bottle $0.041 — Availability likely —
Childrens Loratadine Sugar Free 5 mg/5mL 70677-1058-01 STRATEGIC 1 bottle $0.041 — Availability likely —
Sunmark childrens loratadine 5 mg/5mL 49348-0636-34 Strategic 1 bottle $0.042 — FDA listed —
Loratadine 5 mg/5mL 70000-0125-01 Cardinal 1 bottle $0.044 — Availability likely —
good sense childrens allergy relief 5 mg/5mL 00113-1719-06 L. 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 00363-0771-01 WALGREEN 1 bottle — — FDA listed —
Childrens Walitin 5 mg/5mL 00363-2108-08 Walgreen 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 00363-2131-08 Walgreen 1 bottle — — FDA listed —
Claritin Allergy 1 mg/mL 11523-0101-01 Bayer 1 bottle — — FDA listed —
Children Claritin Allergy 5 mg/5mL 11523-4360-01 Bayer 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 11822-0620-00 Rite 1 bottle — — FDA listed —
Childrens Loratadine Oral 5 mg/5mL 17856-6767-01 Atlantic 72 cups — — FDA listed —
Loratadine 5 mg/5mL 21130-0042-24 Better 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0543-26 AmerisourceBergen 1 bottle — — Discontinued —
Loratadine 5 mg/5mL 30142-0062-24 KROGER 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 30142-0723-00 Kroger 1 bottle — — Discontinued —
topcare childrens allergy 5 mg/5mL 36800-0608-26 Topco 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 37808-0131-08 H 1 bottle — — FDA listed —
Equaline Childrens Allergy Relief 5 mg/5mL 41163-0633-26 United 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 41250-0716-00 Meijer, 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 41520-0131-08 American 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 49035-0538-08 Wal-Mart 1 bottle — — FDA listed —
equate childrens allergy 5 mg/5mL 49035-0611-34 Wal-Mart 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 50090-1454-00 A-S 120 ml — — FDA listed —
Childrens Loratadine Oral 5 mg/5mL 50090-7516-00 A-S 1 bottle — — FDA listed —
Childrens Allergy Relief 5 mg/5mL 51316-0611-34 CVS 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 51672-2073-04 Sun 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 51672-2085-01 Sun 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 51672-2108-01 Sun 1 bottle — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 51672-2131-01 Sun 1 bottle — — FDA listed —
Loratadine 5 mg/5mLthis 54838-0554-40 Lannett 120 ml — — FDA listed —
dg health childrens allergy 5 mg/5mL 55910-0611-26 Dolgencorp, 1 bottle — — FDA listed —
childrens allergy 5 mg/5mL 56062-0092-08 Publix 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 58602-0423-11 Aurohealth 1 bottle — — FDA listed —
Childrens Loratadine 5 mg/5mL 62011-0305-01 Strategic 1 bottle — — FDA listed —
welby childrens allergy relief 5 mg/5mL 64024-0023-26 Aldi 1 bottle — — FDA listed —
Good Sense childrens allergy relief 5 mg/5mL 68071-3904-04 NuCare 1 bottle — — FDA listed —
Loratadine 5 mg/5mL 68071-4451-04 NuCare 120 ml — — FDA listed —
Childrens Loratadine Sugar Free 5 mg/5mL 68788-8286-01 Preferred 1 bottle — — FDA listed —
Good Sense childrens allergy relief 5 mg/5mL 68788-8657-01 Preferred 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 69842-0337-26 CVS 1 bottle — — FDA listed —
Childrens Allergy 5 mg/5mL 69842-0535-08 CVS 1 bottle — — FDA listed —
basic care childrens allergy relief 5 mg/5mL 72288-0511-26 Amazon.com 1 bottle — — Discontinued —
Up And Up Childrens Allergy 5 mg/5mL 82442-0207-26 Target 1 bottle — — FDA listed —
childrens allergy relief 5 mg/5mL 72288-0533-34 Amazon.com 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

🏛️
2010
On the market since
Nov 2010
📍
2026
Currently FDA-listed
16 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

FlavorGrape
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 Loratadine 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesbutylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose. Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

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

LabelerLannett Company, Inc.
Application holderLANNETT CO INC
FDA applicationANDA077421 (ANDA)
Labeler code54838
First marketedNov 2010
Product typeHuman Otc Drug
Portfolio171 products on file

More NDCs from Lannett Company, Inc. labeler code 54838

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 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 📄 Questions or Comments 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 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

Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

⏱️ Dosage and Administration 134 words ▾

Directions use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Directions adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information Safety sealed. Do not use if imprinted seal around cap is broken or missing Store between 20° to 25°C (68° to 77°F)

⚠️ Warnings ~2 min read ▾

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

When using this product do not take more than directed. Taking more than directed may cause drowsiness. 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.

Warnings Severe Allergy Warning : Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use - to prevent hives from any known cause such as: foods insects stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious.

If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. - if you have ever had an allergic reaction to this product (loratadine) or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch When using this product do not take more than directed.

Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Get medical help right away symptoms don’t improve after 3 days of treatment the hives have lasted more than 6 weeks 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.

🧪 Active Ingredient 18 words ▾

Active Ingredient: Loratadine 5 mg (in each 5 mL)

Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful(tsp)))

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

Inactive ingredients Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

🎯 Purpose 4 words ▾

Purpose: Antihistamine

Purpose: Antihistamine

📄 Do Not Use 94 words ▾

Do not use - to prevent hives from any known cause such as: foods insects stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious.

If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. - if you have ever had an allergic reaction to this product (loratadine) or any of its ingredients

📄 Ask a Doctor Before Use If 59 words ▾

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

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch

📄 When Using This Product 34 words ▾

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

📄 Stop Use and Ask a Doctor If 54 words ▾

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Get medical help right away symptoms don’t improve after 3 days of treatment the hives have lasted more than 6 weeks

🤰 If Pregnant or Breast-Feeding 22 words ▾

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

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

📄 Keep Out of Reach of Children 44 words ▾

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 25 words ▾

Questions or comments? 1-844-834-0530 Distributed by: Lannett Company, Inc. Philadelphia, PA 19136

Questions 1-844-834-0530 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512

📄 Patient Package Insert ~3 min read ▾

Patient Leaflet Once Daily / Non-Drowsy* Loratadine Oral Solution Hives Relief 5 mg per 5 mL Antihistamine What you should know about: Non- Drowsy* Loratadine Oral Solution – Hives Relief Original Prescription Strength – 24 Hour Product Relief of Itching Due to Hives (Please read all of this information before taking Loratadine Oral Solution – Hives Relief Product. Save this leaflet for future reference.) What is Loratadine Oral Solution - Hives Relief product? Loratadine Oral Solution - Hives Relief product contain loratadine, a non-drowsy *antihistamine.

Loratadine Oral Solution – Hives Relief Original prescription strength medicine to relieve itching due to hives. What are hives and what do they look like? Hives are itchy raised red or pink bumps, blotches or streaky areas of various sizes on the surface of the skin.

They can come and go. Do not use this product if your hives look bruised, have an unusual color, or look blistered. These may be signs of a more serious problem.

If you have these signs, ask a Doctor before taking Loratadine Oral Solution -Hives Relief product. What can cause hives? Many things, including food, drugs (medicines), insect stings, stress, exercise or temperature can cause hives.

A doctor may be able to help you find the cause of your hives. When you know the cause, avoid it. Do not use this product to prevent hives or allergic skin reactions known to be caused by food, insect stings, medicines, latex or rubber gloves, or any other causes.

Many medicines can cause hives. How long do hives last? Hives can last from a few hours to a few weeks, and often come and go.

See a doctor if your hives have lasted more than 6 weeks. Are hives very serious? Hives are very common and they are usually not serious.

But in rare cases, they can be the first sign of a life threatening allergic reaction called anaphylaxis. A sign that you have this serious reaction would be that you have hives along with any of the following symptoms: Dizziness or feeling faint Trouble swallowing Wheezing or problems breathing Trouble speaking Hives or swelling in or around the mouth Drooling Hives AND any of these symptoms means call 911 or Get Immediate Medical Help Can I use Loratadine Oral Solution -Hives Relief product instead of an epinephrine injection for my allergic reaction?

Never use Loratadine Oral Solution – Hives Relief product as a substitute for epinephrine. If your doctor has prescribed an epinephrine injector for your severe allergic reactions, your doctor is concerned that your hives might lead to a severe allergic reaction (anaphylaxis) or to asthma-like symptoms that could occur with your hives. Loratadine Oral Solution – Hives Relief product is not a substitute for epinephrine.

If you have been prescribed an epinephrine injector, carry it with you at all times. Who can take Loratadine Oral Solution – Hives Relief Product? People who have hives (urticaria) and are 6 years of age or older can take Loratadine Oral Solution – Hives Relief product.

(See label Directions for proper dose.) Who should not take Loratadine Oral Solution – Hives Relief Product? People who have ever had an allergic reaction to these products or any of their ingredients. People who are taking any other products containing loratadine People with liver or kidney disease unless directed by a doctor Children under the age of 6 years.

What if I know the cause of my hives and I want to take Loratadine Oral Solution – Hives Relief Product to prevent the hives from occurring? Loratadine Oral Solution – Hives Relief product should never be used to prevent hives or allergic skin reactions from any known cause. Such causes can include but are not limited to: Food Insect Stings Medicines Latex or rubber gloves.

If you have ever had an allergic reaction to any of these causes, you should see a doctor. When should you contact a doctor? Contact a doctor before taking Loratadine Oral Solution – Hives Relief product if you have: Hives that have an unusual col… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

SPL carton

Hives Carton

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

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 Lannett Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lannett Company, 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.
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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.