FDA.reportPublic FDA data

Loratadine Orally Disintegrating Tablets USP 10 mg

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2022-06-20
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:52

Label at a glance#

ProductLoratadine ODT
Active ingredientLORATADINE
Label structure14 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

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

Storage and handling

Phenylketonurics: Contains phenylalanine 2.25 mg per tablet do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister Complies with USP test 2 for Disintegration

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION


  • 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

Other information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122

Distributed by:

AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy LivingTM

Original Prescription Strength        *When taken as directed. See Drug Facts Panel.

LORATADINE
orally disintegrating tablets USP 10 mg

Antihistamine
Non-Drowsy
Indoor & Outdoor Allergies

†Compare
to the Active
Ingredient in
Claritin®
RediTabs®

24 Hour                                                                     ACTUAL SIZE
                                                                                      60 (6 X 10)
• Relief of sneezing, runny nose, itchy,
  watery eyes & itchy throat or nose                        Orally Disintegrating
• No water needed — melts in your mouth                        Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating TabletsPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN1
311373loratadine 10 MG Disintegrating Oral TabletSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-881-15Loratadine ODT6 in 1 CARTONTABLET, ORALLY DISINTEGRATING61
58602-881-15Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-881LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC]1Current NDC, Legacy NDC, 2 package rows20220622_a6e04fe7-23d3-47d7-9f18-5c4298fbc28b.zip

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
58602-88158602-881-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
ASPARTAMEZ0H242BBR1IACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PEPPERMINTV95R5KMY2BIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT

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 44.

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
A208477-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11c2088c7a36db…
2026-09-14 22:38:342026-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113a93d1ddd44b…

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
Loratadine ODTLORATADINEAurohealth LLCa6e04fe7-23d3-47d7-9f18-5c4298fbc28b2022-06-20WarningsExact identifier
ndc (package): 58602-881-15
ndc (product): 58602-881
ndc11 (package): 58602088115
spl id: a6e04fe7-23d3-47d7-9f18-5c4298fbc28b
spl set id: a6e04fe7-23d3-47d7-9f18-5c4298fbc28b

Reported adverse events (FAERS/openFDA)#

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