childrens allergy relief loratadine 5 mg Tablet, Chewable
by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · 10 BLISTER PACK in 1 CARTON (51316-133-52) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
NDC 51316-0133-52
🏷️ FDA NDC (as labeled)
51316-133-52
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 →
🆔 Identity & classification
FDA NDC (as labeled)
51316-133-52
Product NDC
51316-133
11-digit billing NDC
51316013352
RxCUI
665078
UNII
7AJO3BO7QN
Application #
ANDA210033
SPL Set ID
bc789b82-56ca-4248-b60a-252d9695636a
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-06-06
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
LORATADINE
Why two NDCs?
The FDA registers this code as 51316-133-52 — 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 → 51316-0133-52. 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
LabelerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application holderPERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO
FDA applicationANDA210033 (ANDA)
Labeler code51316
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio117 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
📗 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
-
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
-
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 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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesartificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, 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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 |
|---|---|---|---|---|---|---|
| Loratadine 5 mg 51660-0753-31 | Ohm | 10 tablets | $0.404 | — | FDA listed | — |
| Childrens Loratadine 5 mg 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 | — |
| foster and thrive childrens allergy relief 5 mg 70677-1043-01 | Strategic | 1 tablet | $0.523 | — | Availability likely | — |
| 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 mgthis 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
🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.
🔬 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 allergy relief (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 67%
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 |
|---|---|---|---|
| 51316-0133-52 You're viewing this | 10 BLISTER PACK in 1 CARTON (51316-133-52) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 2024-06-06 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51316-133-52, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51316-0133-52, written without dashes as 51316013352. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51316-0133-52, the first segment (51316) is the labeler code FDA assigned to CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED; the middle segment (0133) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (52) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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 • 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 ▾
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 • phenylketonurics: contains phenylalanine 1.4 mg per tablet • do not use if blister unit is broken or torn • store between 20 ° to 25 ° C (68 ° to 77 ° F)
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Loratadine 5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
🎯 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.