LORATADINE 10 mg Tablet, Orally Disintegrating
by CVS PHARMACY, INC · 4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
NDC 51316-0503-04
🏷️ FDA NDC (as labeled)
51316-503-04
billing pads the product segment with a zero
This package
Contains40 tablet, orally disintegrating in 1 blister pack
Pack sizes6 compare ↓
Also comes in:
10 tablets 51316-0503-01
20 tablets 51316-0503-02
30 tablets 51316-0503-03
50 tablets 51316-0503-05
60 tablets 51316-0503-06
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)
51316-503-04
Product NDC
51316-503
11-digit billing NDC
51316050304
RxCUI
311373
UNII
7AJO3BO7QN
Application #
ANDA213294
SPL Set ID
7ed2aec0-4da7-4edc-9998-b96c67c82738
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-08-08
Route
ORAL
Dosage form
TABLET, ORALLY DISINTEGRATING
Substance
LORATADINE
Why two NDCs?
The FDA registers this code as 51316-503-04 — 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 → 51316-0503-04. 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 PHARMACY, INC
Application holderINSTAPILL PRIVATE LTD
FDA applicationANDA213294 (ANDA)
Labeler code51316
First marketedAug 2021
Product typeHuman Otc Drug
Portfolio102 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.
💊 What it looks like
Color
white
ShapeRound
ImprintT10
Size12 mm
ScoringNot scored
FlavorMint
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 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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII 8ZQ0AYU1TT
Pullulan is a natural polysaccharide, a type of carbohydrate made from yeast. It acts as a binder and film-former to hold tablet ingredients together and create protective coatings on capsules.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan
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 ODT 10 mg 00536-1367-07 | Rugby | 10 tablets | $0.533 | — | Availability likely | — |
| Loratadine ODT 10 mg 46122-0539-52 | Amerisource | 10 tablets | $0.533 | — | Availability likely | — |
| Loratadine 10 mg 72888-0029-09 | Advagen | 10 tablets | $0.533 | — | Availability likely | — |
| good sense allergy relief 10 mg 00113-1191-65 | L. | 1 tablet | — | — | FDA listed | — |
| good sense allergy relief 10 mg 00113-9755-65 | L. | 1 tablet | — | — | FDA listed | — |
| Childrens Loratadine Odt 10 mg 00363-4020-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 00363-9937-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mg 11523-4329-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mg 11523-7157-02 | Bayer | 10 tablets | — | — | FDA listed | — |
| loratadine 10 mg 11822-0558-00 | Rite | 1 tablet | — | — | FDA listed | — |
| loratadine 10 mg 11822-0919-00 | Rite | 1 tablet | — | — | Discontinued | — |
| Loratadine ODT 10 mg 21130-0221-84 | Better | 10 tablets | — | — | FDA listed | — |
| signature care allergy relief 10 mg 21130-0301-65 | Safeway | 1 tablet | — | — | Discontinued | — |
| signature care allergy relief 10 mg 21130-0452-65 | Safeway | 1 tablet | — | — | FDA listed | — |
| allergy relief 10 mg 30142-0446-65 | Kroger | 1 tablet | — | — | FDA listed | — |
| Topcare Allergy Relief 10 mg 36800-0853-65 | Topco | 1 tablet | — | — | FDA listed | — |
| non drowsy allergy relief 10 mg 41250-0890-65 | Meijer | 1 tablet | — | — | FDA listed | — |
| careone allergy relief 10 mg 41520-0510-65 | American | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0707-30 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0758-10 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 49035-0806-03 | Wal-Mart | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mgthis 51316-0503-04 | CVS | 40 tablets | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0931-46 | CVS | 1 tablet | — | — | FDA listed | — |
| Allergy Relief 10 mg 51660-0527-31 | Ohm | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 53943-0035-03 | DISCOUNT | 10 tablets | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0594-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0970-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| Allervarx 10 mg 57483-0950-10 | Innovus | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0744-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0821-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0830-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0881-15 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 59556-0917-01 | Strides | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 60000-0950-83 | Ahold | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 68016-0088-10 | Chain | 10 tablets | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0190-60 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0195-20 | Foundation | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 69842-0085-03 | CVS | 10 tablets | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0200-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0451-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0501-01 | Tenshi | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0503-06 | Tenshi | 1 tablet | — | — | FDA listed | — |
| equate loratadine 10 mg 79903-0381-10 | WALMART | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0110-18 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0120-60 | Foundation | 1 tablet | — | — | FDA listed | — |
| Allergy Relief 10 mg 79481-9723-01 | Meijer, | 1 tablet | — | — | 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
🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 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 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 |
|---|---|---|---|
| 51316-0503-01 | 1 BLISTER PACK in 1 CARTON (51316-503-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
| 51316-0503-02 | 2 BLISTER PACK in 1 CARTON (51316-503-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
| 51316-0503-03 | 3 BLISTER PACK in 1 CARTON (51316-503-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
| 51316-0503-04 You're viewing this | 4 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
| 51316-0503-05 | 5 BLISTER PACK in 1 CARTON (51316-503-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
| 51316-0503-06 | 6 BLISTER PACK in 1 CARTON (51316-503-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-08-08 | Active |
Pack size FAQ
What quantity is in NDC 51316-0503-04?
NDC 51316-0503-04 is listed by the FDA — 4 blister pack in 1 carton / 40 tablet, orally disintegrating in 1 blister pack.
What NDC number is used to bill for this package of LORATADINE 10 mg Tablet, Orally Disintegrating?
Bill NDC 51316-0503-04 — the 11-digit billing format is 51316050304. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 51316-503-04, 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: 51316-0503-04, written without dashes as 51316050304. 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 51316-0503-04, the first segment (51316) is the labeler code FDA assigned to CVS PHARMACY, INC; the middle segment (0503) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 PHARMACY, INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 10 tablets (51316-0503-01), 20 tablets (51316-0503-02), 30 tablets (51316-0503-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CVS PHARMACY, INC 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 place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 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.
📦 Storage and Handling ▾
Other information safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Loratadine 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan
🎯 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.