HomeNDC LookupIngredientsLoratadine › 41250-0716-34
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childrens allergy relief Loratadine 5 mg/5mL Solution

by Meijer, Inc. · 1 BOTTLE in 1 CARTON (41250-716-34) / 240 mL in 1 BOTTLE
NDC 41250-0716-34
🏷️ FDA NDC (as labeled) 41250-716-34 billing pads the product segment with a zero
This package
Contains240 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 118 mL 41250-0716-00
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) 41250-716-34
Product NDC 41250-716
11-digit billing NDC 41250071634
RxCUI 692783
UNII 7AJO3BO7QN
Application # ANDA075728
SPL Set ID f71d9155-e5fb-4735-86f6-59dd9abf6be0
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-24
Route ORAL
Dosage form SOLUTION
Substance LORATADINE
Why two NDCs? The FDA registers this code as 41250-716-34 — 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 → 41250-0716-34. 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

LabelerMeijer, Inc.
Application holderL PERRIGO CO
FDA applicationANDA075728 (ANDA)
Labeler code41250
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio200 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

📗 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 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: 118 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.

🔁 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/5mLthis 41250-0716-34 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🔬 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 childrens allergy relief (this brand).

Top reported reactions

Fatigue17,304
Pain15,124
Headache12,162
Nausea11,084
Rash10,729
Dyspnoea10,699
Arthralgia9,985

Age at onset

Neonate127
Infant97
Child1,130
Adolescent961
Adult17,557
Elderly8,425

Reporter sex

141,163 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization41,358
Death15,209
Life-threatening9,040
Disabling8,742
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,355 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
41250-0716-00 1 BOTTLE in 1 CARTON (41250-716-00) / 118 mL in 1 BOTTLE 2021-06-29 Active
41250-0716-34 You're viewing this 1 BOTTLE in 1 CARTON (41250-716-34) / 240 mL in 1 BOTTLE 2018-07-24 Active

Pack size FAQ

What quantity is in NDC 41250-0716-34?
NDC 41250-0716-34 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 childrens allergy relief Loratadine 5 mg/5mL Solution?
Bill NDC 41250-0716-34 — the 11-digit billing format is 41250071634. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 41250-716-34, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 41250-0716-34, written without dashes as 41250071634. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 41250-0716-34, the first segment (41250) is the labeler code FDA assigned to Meijer, Inc.; the middle segment (0716) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Meijer, Inc.. 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 (41250-0716-00). 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?
Meijer, 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.

📄 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 30 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 98 words

Directions • use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information • do not use if carton is opened, or if printed neckband is broken or missing • store between 20° to 25°C (68° to 77°F)

⚠️ Warnings 111 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 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 (1-800-222-1222).

📦 Storage and Handling 27 words

Other information • do not use if carton is opened, or if printed neckband is broken or missing • store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 10 words

Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg

🧪 Inactive Ingredients 28 words

Inactive ingredients edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose Questions or comments? 1-800-719-9260

🎯 Purpose 2 words

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.