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Sunmark childrens loratadine 5 mg/5mL Solution — NDC 49348-0636-34 package photo

Sunmark childrens loratadine 5 mg/5mL Solution

by Strategic Sourcing Services LLC · 1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE
NDC 49348-0636-34
🏷️ FDA NDC (as labeled) 49348-636-34 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) 49348-636-34
Product NDC 49348-636
11-digit billing NDC 49348063634
NCPDP billing unit ML — per mL (volume)
RxCUI 692783
UNII 7AJO3BO7QN
Application # ANDA076805
SPL Set ID ed94cba7-c2c4-4cbe-9021-f554a51d51f2
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 41550030001220
GPI class SM 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 SM 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 49348-636-34 — 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 → 49348-0636-34. 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 code49348
First marketedAug 2004
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 SM 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 peach 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 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 $0.043 $5.10 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0928 $11.14 / 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
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.047 $0.037
▲ Up 15% over the last 15 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 save 3%
Childrens Loratadine Oral 5 mg/5mL 00904-6767-20 Major 1 bottle $0.041 — Availability likely save 3%
Good Neighbor Pharmacy Childrens Loratadine 5 mg/5mL 24385-0531-26 AmerisourceBergen 1 bottle $0.041 — Availability likely save 3%
good neighbor pharmacy childrens loratadine 5 mg/5mL 46122-0787-34 Amerisource 1 bottle $0.041 — Availability likely save 3%
Loratadine 5 mg/5mL 54838-0558-40 Lannett 120 ml $0.041 — Availability likely save 3%
Loratadine 5 mg/5mL 68001-0449-98 BluePoint 1 bottle $0.041 — Availability likely save 3%
Loratadine 5 mg/5mL 69230-0322-12 Camber 1 bottle $0.041 — Availability likely save 3%
leader childrens allergy relief 5 mg/5mL 70000-0473-01 Cardinal 1 bottle $0.041 — Availability likely save 3%
Loratadine 5 mg/5mL 70677-1057-01 STRATEGIC 1 bottle $0.041 — Availability likely save 3%
Childrens Loratadine Sugar Free 5 mg/5mL 70677-1058-01 STRATEGIC 1 bottle $0.041 — Availability likely save 3%
Sunmark childrens loratadine 5 mg/5mLthis 49348-0636-34 Strategic 1 bottle $0.042 — FDA listed —
Loratadine 5 mg/5mL 70000-0125-01 Cardinal 1 bottle $0.044 — Availability likely +3%
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.

🗺️ 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 49348-0636-34, 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
1.2K
Units reimbursed last 4 qtrs
177.3K
Gross reimbursed last 4 qtrs
$16.4K
Avg / prescription
$13.90
Avg / unit
$0.0928
Latest quarter Q1 2026
14Rx
Medicaid pays / mL
$0.0928
gross reimbursed
vs
NADAC / mL
$0.0425
acquisition cost
=
Spread
+$0.0503
+118% 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 ⓘ
42% FFS 58% MCO
Fee-for-service · 502 Rx Managed care · 681 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: 13,877 units · 70.9 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: 2,310 units · 19.6 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 1,260 units · 13.6 per 100k residents NJ Massachusetts: no data reported MA California: 7,426 units · 19.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 34,880 units · 1,763 per 100k residents NE Missouri: no data reported MO Kentucky: 10,225 units · 226 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 2,010 units · 32.5 per 100k residents 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: 2,880 units · 93.9 per 100k residents AR Tennessee: 8,520 units · 120 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 9,633 units · 211 per 100k residents LA Mississippi: 12,890 units · 438 per 100k residents MS Alabama: 41,125 units · 805 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 30,295 units · 99.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.61,763
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 Nebraska 1,763 /100k
2 Alabama 805 /100k
3 Mississippi 438 /100k
4 Kentucky 226 /100k
5 Louisiana 211 /100k
6 Tennessee 120 /100k
7 Texas 99.3 /100k
8 Arkansas 93.9 /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 Sunmark childrens loratadine (this brand).

Top reported reactions

Fatigue3,295
Nausea2,747
Dyspnoea2,491
Headache2,459
Diarrhoea2,427
Dizziness2,114
Pain2,018

Age at onset

Neonate30
Infant16
Child333
Adolescent338
Adult5,585
Elderly3,093

Reporter sex

48,839 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization13,908
Life-threatening1,618
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
49348-0636-34 You're viewing this 1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE 2012-11-14 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 itchy, watery eyes sneezing itching of the nose or throat

⏱️ Dosage and Administration 51 words ▾

Directions adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor

⚠️ Warnings 109 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.

📦 Storage and Handling 23 words ▾

Other information safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 5 mL) 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49348-0622-37 · Strategic 49348-0689-72 · Strategic →
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.