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Childrens Loratadine 5 mg Tablet, Chewable — NDC 51660-0754-31 package photo

Childrens Loratadine 5 mg Tablet, Chewable

by Ohm Laboratories Inc. · 3 BLISTER PACK in 1 CARTON (51660-754-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
NDC 51660-0754-31
🏷️ FDA NDC (as labeled) 51660-754-31 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 51660-754-31
Product NDC 51660-754
11-digit billing NDC 51660075431
NCPDP billing unit EA — each (per item)
RxCUI 665078
UNII 7AJO3BO7QN
Application # ANDA210088
SPL Set ID c088c998-d823-4bd0-9382-b567221f85a7
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-30
Route ORAL
Dosage form TABLET, CHEWABLE
Substance LORATADINE
GPI-14 41550030000520
GPI class Loratadine Childrens
GCN Seq No 062340
GCN 98118
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 TAB CHEW
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 51660-754-31 — 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 → 51660-0754-31. 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

LabelerOhm Laboratories Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA210088 (ANDA)
Labeler code51660
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio30 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 TAB CHEW 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.

💊 What it looks like

Color pink
ShapeRound
Imprint754
Size1 mm
ScoringNot scored
FlavorBubble Gum
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII TZ8Z31B35M
    Cochineal is a natural red colorant derived from insects, used to give medicines and supplements their red or pink appearance. It helps make tablets and capsules visually identifiable.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesaspartame, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

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 eaPer package
Retail pharmacies payNADAC · weekly $0.511 $15.34 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $0.6704 $20.11 / 30 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
May 2022 Dec 2025 Jan 2026 Feb 2026 $0.511 $0.404
▲ Up 27% over the last 4 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
Loratadine 5 mg 51660-0753-31 Ohm 10 tablets $0.404 — FDA listed save 21%
Childrens Loratadine 5 mgthis 51660-0754-31 Ohm 10 tablets $0.511 — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51660-0112-31 Ohm 10 tablets $0.523 — Availability likely +2%
foster and thrive childrens allergy relief 5 mg 70677-1043-01 Strategic 1 tablet $0.523 — Availability likely +2%
good sense childrens allergy relief 5 mg 00113-1019-39 L. 1 tablet — — Discontinued —
Loratadine 5 mg 00363-0752-30 WALGREEN 10 tablets — — FDA listed —
Wal-itin 5 mg 00363-0754-30 Walgreens 10 tablets — — FDA listed —
Loratadine 5 mg 00363-9985-30 WALGREENS 10 tablets — — FDA listed —
Wal-itin 5 mg 00363-9995-30 WALGREENS 10 tablets — — FDA listed —
Claritin 5 mg 11523-0104-01 Bayer 10 tablets — — FDA listed —
Claritin Chewable Grape and Bubblegum 11523-0123-01 Bayer 1 kit — — FDA listed —
Claritin 5 mg 11523-4328-01 Bayer 10 tablets — — FDA listed —
Claritin 5 mg 11523-4330-01 Bayer 10 tablets — — FDA listed —
Claritin 5 mg 11523-4331-01 Bayer 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11673-0111-30 UP 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11673-0115-30 UP 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 11673-0310-30 TARGET 10 tablets — — FDA listed —
Childrens Allergy 5 mg 11673-0996-30 TARGET 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 11673-0997-30 TARGET 10 tablets — — FDA listed —
childrens allergy relief 5 mg 11822-0801-01 Rite 1 tablet — — FDA listed —
Loratadine 5 mg 11822-7240-00 Rite 30 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11822-8329-07 RITE 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 11822-9999-03 RITE 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 21130-0646-20 SAFEWAY 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 21130-0963-20 SAFEWAY 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 21130-0999-20 SAFEWAY 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0565-30 KROGER 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0984-30 KROGER 10 tablets — — FDA listed —
Loratadine 5 mg 30142-0996-30 KROGER 10 tablets — — FDA listed —
topcare childrens allergy relief 5 mg 36800-0363-39 Topco 1 tablet — — FDA listed —
Childrens Allergy Relief 5 mg 37808-0506-39 H 1 tablet — — FDA listed —
Equaline Childrens Allergy Relief 5 mg 41163-0364-01 United 1 tablet — — FDA listed —
childrens allergy relief 5 mg 41250-0629-39 Meijer 1 tablet — — FDA listed —
careone childrens allergy relief 5 mg 41520-0716-01 American 1 tablet — — FDA listed —
Childrens Loratadine 5 mg 46122-0550-60 Amerisource 10 tablets — — Discontinued —
Loratadine 5 mg 49035-0953-30 Wal-Mart 10 tablets — — FDA listed —
childrens allergy relief 5 mg 51316-0133-52 CVS 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51316-0821-20 CVS 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 51660-0726-30 Ohm 10 tablets — — FDA listed —
dg health childrens allergy relief 5 mg 55910-0807-52 Dolgencorp, 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 56062-0900-20 PUBLIX 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 56062-0921-20 PUBLIX 10 tablets — — FDA listed —
Loratadine 5 mg 56062-0990-20 PUBLIX 10 tablets — — FDA listed —
Loratadine 5 mg 68016-0053-10 Premier 10 tablets — — FDA listed —
Berkley and Jensen Childrens Allergy Relief 5 mg 68391-0301-49 BJWC 1 tablet — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 69842-0894-30 CVS 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 69842-0895-20 CVS 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 69842-0953-20 CVS 10 tablets — — FDA listed —
Childrens Loratadine 5 mg 69842-0954-30 CVS 10 tablets — — FDA listed —
Basic Care Childrens Allergy Relief 5 mg 72288-0901-01 Amazon.com 1 tablet — — FDA listed —
Curist Childrens Allergy Relief 5 mg 72559-0031-43 Little 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 79903-0008-30 WAL-MART 10 tablets — — FDA listed —
Dye-Free Childrens Loratadine 5 mg 79903-0330-30 WAL-MART 10 tablets — — FDA listed —
Loratadine 5 mg 00363-9994-30 WALGREENS 10 tablets — — 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
Jun 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.

🗺️ 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 51660-0754-31, 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
172
Units reimbursed last 4 qtrs
5.5K
Gross reimbursed last 4 qtrs
$3.7K
Avg / prescription
$21.52
Avg / unit
$0.6704
Latest quarter Q4 2025
38Rx
Medicaid pays / ea
$0.6704
gross reimbursed
vs
NADAC / ea
$0.5113
acquisition cost
=
Spread
+$0.1591
+31% vs cost
What Medicaid paid per ea (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 ⓘ
52% FFS 48% MCO
Fee-for-service · 90 Rx Managed care · 82 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,654 units · 8.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 441 units · 3.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,290 units · 3.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 450 units · 9.9 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 1,687 units · 57.4 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.357.4
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 Mississippi 57.4 /100k
2 Kentucky 9.9 /100k
3 New York 8.5 /100k
4 Pennsylvania 3.4 /100k
5 California 3.3 /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 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 Marketing startStatus
51660-0754-31 You're viewing this 3 BLISTER PACK in 1 CARTON (51660-754-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2018-06-30 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

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

⏱️ Dosage and Administration 65 words ▾

Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet 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 phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Loratadine USP, 5 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients aspartame, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

🎯 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 ↗
← 51660-0753-31 · Ohm 51660-0755-02 · Ohm →
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.