HomeNDC LookupIngredientsLoratadine › 51672-2085-01
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Childrens Loratadine 5 mg/5mL Solution

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE in 1 CARTON (51672-2085-1) / 240 mL in 1 BOTTLE
NDC 51672-2085-01
🏷️ FDA NDC (as labeled) 51672-2085-1 billing pads the package segment with a zero
This package
Contains240 mL in 1 bottle Pack sizes4 compare ↓
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) 51672-2085-1
Product NDC 51672-2085
11-digit billing NDC 51672208501
RxCUI 692783
UNII 7AJO3BO7QN
Application # ANDA076805
SPL Set ID 12c8066a-3429-481e-b63a-7ea2b439a170
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-08-20
Route ORAL
Dosage form SOLUTION
Substance LORATADINE
GPI-14 41550030002020
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 5 MG/5 ML SYRUP
FDB brand name Loratadine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 51672-2085-1 — 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 → 51672-2085-01. 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 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076805 (ANDA)
Labeler code51672
First marketedAug 2004
Product typeHuman Otc Drug
Portfolio889 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 5 MG/5 ML SYRUP 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
  • 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.

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

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 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 statesartificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

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 DailyMedingredient 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.

💲 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: 60 mL 180 mL 120 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 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/5mLthis 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

🏛️
2004
On the market since
Aug 2004
📍
2026
Currently FDA-listed
22 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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle51672-2085-08 1,594 Rx · $23,835
1 bottle51672-2085-04 No Medicaid data
1 bottle51672-2085-05 No Medicaid data
Drug total (last 4 qtrs): 1,594 Rx · 201,833 units · $23,835 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 LORATADINE (this brand).

Top reported reactions

Fatigue3,296
Nausea2,748
Dyspnoea2,491
Headache2,460
Diarrhoea2,428
Dizziness2,114
Pain2,018

Reporter sex

0 reports

Serious outcomes

Hospitalization13,912
Death2,893
Life-threatening1,619
Disabling1,268
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,225 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 Per unit Per pack Marketing startStatus
51672-2085-01 You're viewing this 1 BOTTLE in 1 CARTON (51672-2085-1) / 240 mL in 1 BOTTLE 2004-08-20 Active
51672-2085-04 1 BOTTLE in 1 CARTON (51672-2085-4) / 60 mL in 1 BOTTLE 2004-08-20 Active
51672-2085-05 1 BOTTLE in 1 CARTON (51672-2085-5) / 180 mL in 1 BOTTLE 2004-08-20 Active
51672-2085-08 1 BOTTLE in 1 CARTON (51672-2085-8) / 120 mL in 1 BOTTLE $0.0425 / mL $5.10 2004-08-20 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-2085-01?
NDC 51672-2085-01 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 Loratadine 5 mg/5mL Solution?
Bill NDC 51672-2085-01 — the 11-digit billing format is 51672208501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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) ✓ 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 51672-2085-1, 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: 51672-2085-01, written without dashes as 51672208501. 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 51672-2085-01, the first segment (51672) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (2085) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Sun Pharmaceutical Industries, 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 3 other package presentations of this same product, including 1 bottle (51672-2085-04), 1 bottle (51672-2085-05), 1 bottle (51672-2085-08). 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?
Sun Pharmaceutical Industries, 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 26 words

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

⏱️ Dosage and Administration 70 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

⚠️ Warnings 110 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 32 words

Other information do not use if carton is opened, or if imprinted safety seal is broken or missing see bottom panel for expiration date 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 18 words

Inactive ingredients artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

🎯 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.