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Loratadine 5 mg/5mL Solution — NDC 70000-0125-1 (Billing 70000-0125-01)

by Cardinal Health, 110 dba LEADER · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

This is a package of Loratadine 5 mg/5mL Solution from Cardinal Health, 110 dba LEADER, marketed since Aug 2004 and currently FDA-listed; retail pharmacies pay about $0.0436 per mL (NADAC). It is this product's only package size.

NDC 70000-0125-01
🏷️ FDA NDC (as labeled) 70000-0125-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0125-1
Product NDC 70000-0125
11-digit billing NDC 70000012501
NCPDP billing unit ML — per mL (volume)
RxCUI 692783
UNII 7AJO3BO7QN
Application # ANDA076805
SPL Set ID db9d2182-6bf1-424a-a144-f2694c47989f
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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 41550030002020
GPI class Allergy Childrens
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 ALLERGY 5 MG/5 ML SOLN
FDB brand name Children's Allergy
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 018697
  • GCN: 60562
  • GPI-14 (Medi-Span): 41550030002020
  • HICL (First Databank): 007605
  • AHFS class code: 04:08.00.00
  • RxCUI (RxNorm): 692783
Why two NDCs? The FDA registers this code as 70000-0125-1 — 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 → 70000-0125-01. 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.

Clinical

Label name CHILD ALLERGY 5 MG/5 ML SOLN Ingredient Loratadine
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves symptoms of hay fever and other upper respiratory allergies. That means runny nose, sneezing, itchy, watery eyes, and an itchy nose or throat.
  • It is taken by mouth, generally once a day. Follow the directions on your specific product. Chewable tablets should be chewed or crushed completely, and liquids should be measured...
  • No. Do not take more than directed. Taking more than directed may cause drowsiness. If you think you took too much, get medical help or call Poison Control right away.
  • Can I take extra if my allergies are bad?
📖 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.

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 $0.044 $5.14 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0778 $9.18 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Dec 2025 Apr 2026 Sep 2026 $0.045 $0.043
Flat over the last 14 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0125-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2016-10-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense childrens allergy relief 5 mg/5mL 00113-0671-26 L. 1 bottle $0.041 — Availability likely save 5%
Childrens Loratadine Oral 5 mg/5mL 00904-6767-20 Major 1 bottle $0.041 — Availability likely save 5%
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0531-26 AmerisourceBergen 1 bottle $0.041 — Availability likely save 5%
good neighbor pharmacy childrens loratadine 5 mg/5mL 46122-0787-34 Amerisource 1 bottle $0.041 — Availability likely save 5%
Loratadine 5 mg/5mL 54838-0558-40 Lannett 120 ml $0.041 — Availability likely save 5%
Loratadine 5 mg/5mL 68001-0449-98 BluePoint 1 bottle $0.041 — Availability likely save 5%
Loratadine 5 mg/5mL 69230-0322-12 Camber 1 bottle $0.041 — Availability likely save 5%
leader childrens allergy relief 5 mg/5mL 70000-0473-01 Cardinal 1 bottle $0.041 — Availability likely save 5%
Loratadine 5 mg/5mL 70677-1057-01 STRATEGIC 1 bottle $0.041 — Availability likely save 5%
Childrens Loratadine Sugar Free 5 mg/5mL 70677-1058-01 STRATEGIC 1 bottle $0.041 — Availability likely save 5%
Sunmark childrens loratadine 5 mg/5mL 49348-0636-34 Strategic 1 bottle $0.042 — FDA listed save 3%
Loratadine 5 mg/5mLthis 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/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

🏛️
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.

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.

Manufacturer & labeler

LabelerCardinal Health, 110 dba LEADER
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076805 (ANDA)
Labeler code70000
First marketedAug 2004
Product typeHuman Otc Drug
Portfolio34 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 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 10 words ▾

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

🧪 Inactive Ingredients 18 words ▾

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

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 19 words ▾

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 22 words ▾

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 17 words ▾

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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)

📄 Questions or Comments 3 words ▾

Questions? Call 1-866-923-4914

📄 Package Label / Principal Display Panel 94 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton LEADER ™ Non-Drowsy † Children's Allergy Loratadine Oral Solution USP, 5 mg/5 mL Antihistamine Allergy Indoor & Outdoor Allergies Fruit Flavor Dye Free 24 Hour Relief of: Sneezing Runny Nose Itchy Watery Eyes Itchy Throat or Nose Ages 2 Years and Older COMPARE TO CHILDREN'S CLARITIN ® active ingredient* 100% Money Back Guarantee † When taken as directed. See Drug Facts Panel. WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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
7.1K
Units reimbursed last 4 qtrs
1M
Gross reimbursed last 4 qtrs
$81.6K
Avg / prescription
$11.45
Avg / unit
$0.0778
Latest quarter Q4 2025
1.8KRx
Medicaid pays / mL
$0.0778
gross reimbursed
vs
NADAC / mL
$0.0436
acquisition cost
=
Spread
+$0.0342
+78% 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 ⓘ
29% FFS 71% MCO
Fee-for-service · 2,048 Rx Managed care · 5,082 Rx
State Medicaid map
Alaska: no data reported AK Maine: 11,461 units · 822 per 100k residents ME Washington: 14,852 units · 190 per 100k residents 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: 157,789 units · 1,572 per 100k residents MI New York: 122,329 units · 625 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 5,087 units · 120 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 21,893 units · 683 per 100k residents IA Illinois: no data reported IL Indiana: 30,059 units · 438 per 100k residents IN Ohio: 18,145 units · 154 per 100k residents OH Pennsylvania: 35,151 units · 271 per 100k residents PA New Jersey: 70,905 units · 763 per 100k residents NJ Massachusetts: no data reported MA California: 95,622 units · 245 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 5,342 units · 270 per 100k residents NE Missouri: 39,472 units · 637 per 100k residents MO Kentucky: 46,456 units · 1,026 per 100k residents KY West Virginia: 17,344 units · 980 per 100k residents WV Virginia: 17,460 units · 200 per 100k residents VA Maryland: 65,279 units · 1,056 per 100k residents MD Connecticut: 6,375 units · 176 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 15,979 units · 756 per 100k residents NM Kansas: 4,974 units · 169 per 100k residents KS Arkansas: no data reported AR Tennessee: 30,821 units · 433 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 27,175 units · 670 per 100k residents OK Louisiana: 13,758 units · 301 per 100k residents LA Mississippi: 3,542 units · 120 per 100k residents MS Alabama: no data reported AL Georgia: 25,508 units · 231 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 61,414 units · 201 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1201,572
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 Michigan 1,572 /100k
2 Maryland 1,056 /100k
3 Kentucky 1,026 /100k
4 West Virginia 980 /100k
5 Maine 822 /100k
6 New Jersey 763 /100k
7 New Mexico 756 /100k
8 Iowa 683 /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.
← 70000-0124-01 · CARDINAL 70000-0127-01 · Cardinal →
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.