FDA.reportPublic FDA data

LORATADINE

Manufacturer
Advagen Pharma Limited | Rubicon Research Limited
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:20

Label at a glance#

ProductLORATADINE
Active ingredientLORATADINE
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active ingredient (in each tablet)                                                                  Purpose
Loratadine USP, 10 mg………………………………….....................Antihistamine
Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat
Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using a productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor ifan 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.
Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of ageask a doctor
Consumers with liver or kidney diseaseask a doctor
Other information
  • Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet.
  • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • FDA approved acceptance criteria for assay and organic impurities differs from USP test
Inactive ingredients
aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate
Questions or comments?
Advagen - 866-488-0312
Distributed by:
Advagen Pharma Ltd
East Windsor, NJ 08520, USA

Manufactured by:
Rubicon Research Ltd.,
Thane 421506, India.

Rev. 02, 11/24

WARNINGS SECTION

OTC - DO NOT USE SECTION

OTC - ASK DOCTOR SECTION

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

SPL UNCLASSIFIED SECTION

Note:Imprint Code - Λ indicated as UpArrowhead in Drug Listing Data Element (DLDE) section.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine Orally Disintegrating Tablets USP 10 mg - 10 Tablets - NDC 72888-029-09

loratadine-odt-usp-10mg-10countloratadine-odt-usp-10mg-10count

Loratadine Orally Disintegrating Tablets USP 10 mg - 30 Tablets - NDC 72888-029-11

loratadine-odt-usp-10mg-30countloratadine-odt-usp-10mg-30count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN2
311373loratadine 10 MG Disintegrating Oral TabletSCD2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130372888029092GTIN-13: 0372888029092
EAN-13: 0372888029092
GTIN-12: 372888029092
UPC-A: 372888029092
GTIN storage (14 digits): 00372888029092		loratadine-odt-usp-10mg-10count.jpg
BarcodeEAN-130372888029115GTIN-13: 0372888029115
EAN-13: 0372888029115
GTIN-12: 372888029115
UPC-A: 372888029115
GTIN storage (14 digits): 00372888029115		loratadine-odt-usp-10mg-30count.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-029-09LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
72888-029-09LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING12
72888-029-11LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
72888-029-11LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-029-09EA - Each72888-02902ce73c3-076c-4525-8a91-fd14e71dac4712022-09-12
72888-029-11EA - Each72888-0295299bbaa-521d-4535-8074-209b5dceb05412022-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72888-02972888-029-09, 72888-029-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE2S7830E561IACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
LORATADINE7AJO3BO7QNACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214280-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1084e616aacf4f…
2026-08-18 06:07:402026-07A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214280-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-10a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORATADINELORATADINEAdvagen Pharma Limiteda5699a95-c0a7-43ea-9bab-bbfaba3c8aa52026-01-05Exact identifier
ndc (package): 72888-029-11
ndc (package): 72888-029-09
ndc (product): 72888-029
ndc11 (package): 72888002911
ndc11 (package): 72888002909
spl id: 47a189dc-792d-a279-e063-6394a90a9adf
spl set id: a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.