Loratadine 5 mg/5mL Solution
by STRATEGIC SOURCING SERVICES LLC · 1 BOTTLE in 1 CARTON (70677-1057-1) / 120 mL in 1 BOTTLE
NDC 70677-1057-01
🏷️ FDA NDC (as labeled)
70677-1057-1
billing pads the package 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 →
🆔 Identity & classification
FDA NDC (as labeled)
70677-1057-1
Product NDC
70677-1057
11-digit billing NDC
70677105701
NCPDP billing unit
ML — per mL (volume)
RxCUI
692783
UNII
7AJO3BO7QN
Application #
ANDA076805
SPL Set ID
6ba7fc5d-81c4-482c-8b38-4a6587853a9f
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-08-01
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
FT CHILD ALLERGY 5 MG/5 ML SOL
FDB brand name
Children's Allergy
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70677-1057-1 — 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 → 70677-1057-01. 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
LabelerSTRATEGIC SOURCING SERVICES LLC
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076805 (ANDA)
Labeler code70677
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio316 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 FT CHILD ALLERGY 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Loratadine — tap one for details:
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.
💬 Questions about Loratadine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.041 | $4.97 / 120 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0879 | $10.55 / 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
▼ Down 2% over the last 10 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/5mLthis 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 | — |
| 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
🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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 70677-1057-01, 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 – Q1 2026 · 5 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
2.6K
Units reimbursed last 4 qtrs
422.2K
Gross reimbursed last 4 qtrs
$37.1K
Avg / prescription
$14.30
Avg / unit
$0.0879
Latest quarter Q1 2026
670Rx
Medicaid pays / mL
$0.0879
gross reimbursed
vs
NADAC / mL
$0.0414
acquisition cost
=
Spread
+$0.0465
+112% 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 ⓘ
Fee-for-service · 1,534 Rx Managed care · 1,061 Rx
State Medicaid map
Units reimbursed · per 100k residents
16.5557
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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 LORATADINE — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 66%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70677-1057-01 You're viewing this | 1 BOTTLE in 1 CARTON (70677-1057-1) / 120 mL in 1 BOTTLE | 2023-08-01 | 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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
🎯 Purpose ▾
Purpose Antihistamine
No label section mentions that — try another word, or open the full label on DailyMed below.
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.