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Childrens Loratadine Sugar Free 5 mg/5mL Solution — NDC 51672-2131-08 package photo

Childrens Loratadine Sugar Free 5 mg/5mL Solution

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLE
NDC 51672-2131-08
🏷️ FDA NDC (as labeled) 51672-2131-8 billing pads the package segment with a zero
This package
Contains120 mL in 1 bottle Cost per mL$0.0414 NADAC Per package$4.97 / 120 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.0638/unit — full pricing hub ↓
OTC Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 51672-2131-8
Product NDC 51672-2131
11-digit billing NDC 51672213108
NCPDP billing unit ML — per mL (volume)
RxCUI 692783
UNII 7AJO3BO7QN
UPC 0351672213183
Application # ANDA076805
SPL Set ID 58eaab62-ac36-4080-8ded-9b472dddc617
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-03-17
Route ORAL
Dosage form SOLUTION
Substance 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 CHILD LORATADINE 5 MG/5 ML SOL
FDB brand name Children's Loratadine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 51672-2131-8 — 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 → 51672-2131-08. 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 marketedMar 2017
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 CHILD LORATADINE 5 MG/5 ML SOL 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.

💊 What it looks like

Color yellow
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.

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

  • 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 D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in 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.

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

The official label also statesbutylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

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.

💲 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 $4.97 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0638 $7.66 / 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.047 $0.039
▲ Up 6% 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 —
Childrens Loratadine Sugar Free 5 mg/5mLthis 51672-2131-08 Sun 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 +3%
Loratadine 5 mg/5mL 70000-0125-01 Cardinal 1 bottle $0.044 — Availability likely +5%
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 —
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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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 51672-2131-08, 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
482.8K
Units reimbursed last 4 qtrs
79.8M
Gross reimbursed last 4 qtrs
$5.09M
Avg / prescription
$10.55
Avg / unit
$0.0638
Latest quarter Q4 2025
126.5KRx
Medicaid pays / mL
$0.0638
gross reimbursed
vs
NADAC / mL
$0.0414
acquisition cost
=
Spread
+$0.0224
+54% 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 ⓘ
34% FFS 66% MCO
Fee-for-service · 163,053 Rx Managed care · 319,774 Rx
State Medicaid map
Alaska: no data reported AK Maine: 208,318 units · 14,933 per 100k residents ME Washington: 470,659 units · 6,025 per 100k residents WA Idaho: 47,894 units · 2,439 per 100k residents ID Montana: 26,795 units · 2,367 per 100k residents MT North Dakota: 7,272 units · 929 per 100k residents ND Minnesota: 545,142 units · 9,502 per 100k residents MN Wisconsin: 513,236 units · 8,684 per 100k residents WI Michigan: 2,101,739 units · 20,940 per 100k residents MI New York: 6,374,978 units · 32,574 per 100k residents NY Vermont: 95,736 units · 14,797 per 100k residents VT New Hampshire: 89,746 units · 6,401 per 100k residents NH Oregon: 220,884 units · 5,218 per 100k residents OR Nevada: 1,457,166 units · 45,622 per 100k residents NV Wyoming: 29,270 units · 5,012 per 100k residents WY South Dakota: 53,861 units · 5,861 per 100k residents SD Iowa: 445,747 units · 13,899 per 100k residents IA Illinois: 803,363 units · 6,402 per 100k residents IL Indiana: 995,239 units · 14,504 per 100k residents IN Ohio: 2,179,109 units · 18,491 per 100k residents OH Pennsylvania: 1,373,672 units · 10,599 per 100k residents PA New Jersey: 1,792,322 units · 19,293 per 100k residents NJ Massachusetts: 3,077,282 units · 43,955 per 100k residents MA California: 9,668,708 units · 24,814 per 100k residents CA Utah: 30,045 units · 879 per 100k residents UT Colorado: 224,281 units · 3,816 per 100k residents CO Nebraska: 755,879 units · 38,214 per 100k residents NE Missouri: 1,689,048 units · 27,260 per 100k residents MO Kentucky: 2,108,010 units · 46,576 per 100k residents KY West Virginia: 469,144 units · 26,505 per 100k residents WV Virginia: 2,463,192 units · 28,261 per 100k residents VA Maryland: 2,123,079 units · 34,354 per 100k residents MD Connecticut: 1,187,905 units · 32,842 per 100k residents CT Rhode Island: 465,569 units · 42,518 per 100k residents RI Arizona: 781,531 units · 10,517 per 100k residents AZ New Mexico: 393,127 units · 18,596 per 100k residents NM Kansas: 384,232 units · 13,069 per 100k residents KS Arkansas: 1,192,267 units · 38,874 per 100k residents AR Tennessee: 1,396,124 units · 19,592 per 100k residents TN North Carolina: 208,674 units · 1,926 per 100k residents NC South Carolina: 2,289,496 units · 42,611 per 100k residents SC Delaware: 359,026 units · 34,823 per 100k residents DE Oklahoma: 2,367,728 units · 58,419 per 100k residents OK Louisiana: 2,684,350 units · 58,687 per 100k residents LA Mississippi: 624,527 units · 21,242 per 100k residents MS Alabama: 1,386,918 units · 27,152 per 100k residents AL Georgia: 10,652,893 units · 96,590 per 100k residents GA D.C.: 243,581 units · 35,873 per 100k residents DC Hawaii: 232,974 units · 16,235 per 100k residents HI Texas: 7,939,598 units · 26,029 per 100k residents TX Florida: 2,082,520 units · 9,211 per 100k residents FL
Units reimbursed · per 100k residents
87996,590
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 Georgia 96,590 /100k
2 Louisiana 58,687 /100k
3 Oklahoma 58,419 /100k
4 Kentucky 46,576 /100k
5 Nevada 45,622 /100k
6 Massachusetts 43,955 /100k
7 South Carolina 42,611 /100k
8 Rhode Island 42,518 /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.

💊 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 bottle this page51672-2131-08 482,827 Rx · $5,092,534
1 bottle51672-2131-01 No Medicaid data
1 bottle51672-2131-04 No Medicaid data
Drug total (last 4 qtrs): 482,827 Rx · 79,782,836 units · $5,092,534 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51672-2131-01 1 BOTTLE in 1 CARTON (51672-2131-1) / 240 mL in 1 BOTTLE — — 2017-03-17 Active
51672-2131-04 1 BOTTLE in 1 CARTON (51672-2131-4) / 60 mL in 1 BOTTLE — — 2017-03-17 Active
51672-2131-08 You're viewing this 1 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLE $0.0414 / mL $4.97 2017-03-17 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-2131-08?
NDC 51672-2131-08 is listed by the FDA — 1 bottle in 1 carton / 120 ml in 1 bottle.
What NDC number is used to bill for this package of Childrens Loratadine Sugar Free 5 mg/5mL Solution?
Bill NDC 51672-2131-08 — the 11-digit billing format is 51672213108. 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.

📄 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 68 words ▾

Directions use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL; 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

⚠️ 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 34 words ▾

Other information do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5 mL) Loratadine 5 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

🎯 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.