HomeNDC LookupIngredientsLoratadine › 54838-0558-40
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Loratadine 5 mg/5mL Solution, 120 mL

by Lannett Company, Inc. · 120 mL in 1 CARTON (54838-558-40)
NDC 54838-0558-40
🏷️ FDA NDC (as labeled) 54838-558-40 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 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) 54838-558-40
Product NDC 54838-558
11-digit billing NDC 54838055840
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
GPI-14 41550030001220
GPI class Childrens Loratadine
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 ALLERGY 5 MG/5 ML
FDB brand name Loratadine Allergy
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 54838-558-40 — 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 → 54838-0558-40. 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.

🏭 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
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 LORATADINE ALLERGY 5 MG/5 ML Ingredient Loratadine
📗 Our plain-language guide HelloPharmacist
  • Loratadine is an antihistamine that temporarily relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat. It works f...
  • When taken as directed, loratadine is considered non-drowsy for most people. However, if you take more than the recommended daily amount, drowsiness can happen. So stick to the dos...
  • It depends on the age. Children 6 and older can take standard adult doses of most forms. Children 2 to under 6 can use the oral solution or chewable tablets, but at a lower amount....
  • You should check with your doctor before taking loratadine if you have liver or kidney disease. Your doctor may need to adjust your dose. It's not necessarily off-limits, but it's...
📖 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.041 $4.96 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0978 $11.74 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.047 $0.037
▲ Up 12% over the last 24 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.

🔁 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/5mLthis 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 +3%
Loratadine 5 mg/5mL 70000-0125-01 Cardinal 1 bottle $0.044 Availability likely +6%
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/5mL 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 54838-0558-40, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
21.6K
Units reimbursed last 4 qtrs
3.2M
Gross reimbursed last 4 qtrs
$316.3K
Avg / prescription
$14.66
Avg / unit
$0.0978
Latest quarter Q4 2025
1.9KRx
Medicaid pays / mL
$0.0978
gross reimbursed
vs
NADAC / mL
$0.0413
acquisition cost
=
Spread
+$0.0565
+137% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
47% FFS 53% MCO
Fee-for-service · 10,144 Rx Managed care · 11,427 Rx
State Medicaid map
Alaska: no data reported AK Maine: 3,725 units · 267 per 100k residents ME Washington: 14,032 units · 180 per 100k residents WA Idaho: 1,620 units · 82.5 per 100k residents ID Montana: 2,638 units · 233 per 100k residents MT North Dakota: no data reported ND Minnesota: 8,708 units · 152 per 100k residents MN Wisconsin: 13,263 units · 224 per 100k residents WI Michigan: 70,758 units · 705 per 100k residents MI New York: 856,709 units · 4,377 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,145 units · 81.7 per 100k residents NH Oregon: 3,482 units · 82.3 per 100k residents OR Nevada: 21,449 units · 672 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,680 units · 509 per 100k residents SD Iowa: 9,507 units · 296 per 100k residents IA Illinois: 9,890 units · 78.8 per 100k residents IL Indiana: 12,308 units · 179 per 100k residents IN Ohio: 48,692 units · 413 per 100k residents OH Pennsylvania: 110,804 units · 855 per 100k residents PA New Jersey: 53,845 units · 580 per 100k residents NJ Massachusetts: 34,050 units · 486 per 100k residents MA California: 249,214 units · 640 per 100k residents CA Utah: no data reported UT Colorado: 2,110 units · 35.9 per 100k residents CO Nebraska: 22,475 units · 1,136 per 100k residents NE Missouri: 78,030 units · 1,259 per 100k residents MO Kentucky: 70,316 units · 1,554 per 100k residents KY West Virginia: 51,212 units · 2,893 per 100k residents WV Virginia: 76,968 units · 883 per 100k residents VA Maryland: 98,064 units · 1,587 per 100k residents MD Connecticut: 42,949 units · 1,187 per 100k residents CT Rhode Island: 1,450 units · 132 per 100k residents RI Arizona: 9,004 units · 121 per 100k residents AZ New Mexico: 13,150 units · 622 per 100k residents NM Kansas: 13,480 units · 459 per 100k residents KS Arkansas: 55,265 units · 1,802 per 100k residents AR Tennessee: 64,345 units · 903 per 100k residents TN North Carolina: 10,163 units · 93.8 per 100k residents NC South Carolina: 39,156 units · 729 per 100k residents SC Delaware: 2,875 units · 279 per 100k residents DE Oklahoma: 18,918 units · 467 per 100k residents OK Louisiana: 327,830 units · 7,167 per 100k residents LA Mississippi: 51,861 units · 1,764 per 100k residents MS Alabama: 97,609 units · 1,911 per 100k residents AL Georgia: 206,974 units · 1,877 per 100k residents GA D.C.: 9,940 units · 1,464 per 100k residents DC Hawaii: no data reported HI Texas: 218,515 units · 716 per 100k residents TX Florida: 17,427 units · 77.1 per 100k residents FL
Units reimbursed · per 100k residents
35.97,167
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 7,167 /100k
2 New York 4,377 /100k
3 West Virginia 2,893 /100k
4 Alabama 1,911 /100k
5 Georgia 1,877 /100k
6 Arkansas 1,802 /100k
7 Mississippi 1,764 /100k
8 Maryland 1,587 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 LORATADINE — the ingredient across all brands.

Top reported reactions

Fatigue6,880
Nausea6,108
Headache5,618
Dyspnoea5,027
Diarrhoea4,995
Dizziness4,683
Pain4,258

Age at onset

Neonate39
Infant137
Child2,951
Adolescent762
Adult13,205
Elderly8,007

Reporter sex

114,197 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization23,691
Death4,744
Life-threatening2,561
Disabling2,302
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,335 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
54838-0558-40 You're viewing this 120 mL in 1 CARTON (54838-558-40) 2010-11-24 Active

📄 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 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

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.