FDA.reportPublic FDA data

Loratadine

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-10-23
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:29:08

Label at a glance#

ProductLoratadine
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

adults and children 6 years and over 1 capsule daily; not more than 1 capsule in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

do not use if the individual blister unit is open or torn store between 20° to 25°C (68° to 77°F) protect from freezing FDA approved dissolution test specifications differ from USP

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

 (in each capsule)

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

Warnings

WARNINGS SECTION

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

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


adults and children 6 years and over
1 capsule daily; not more than 1 capsule 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

  • do not use if the individual blister unit is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
  • FDA approved dissolution test specifications differ from USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

 call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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 (10 Capsule Blister Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-818-83

Compare to the active ingredient

in Claritin® Liqui-Gels®†

Non-Drowsy*

Loratadine Capsules USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

24 HOUR

10 Liquid-Filled Capsules

*When taken as directed.

See Drug Facts Panel.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN2
828269loratadine 10 MG Oral CapsuleSCD2
828269loratadine 10 MG 24HR Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-818-05Loratadine5 in 1 CARTONCAPSULE, LIQUID FILLED52
58602-818-05Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-08Loratadine4 in 1 CARTONCAPSULE, LIQUID FILLED42
58602-818-08Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-67Loratadine2 in 1 CARTONCAPSULE, LIQUID FILLED22
58602-818-67Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-83Loratadine1 in 1 CARTONCAPSULE, LIQUID FILLED12
58602-818-83Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
58602-818-84Loratadine3 in 1 CARTONCAPSULE, LIQUID FILLED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-818LORATADINE CAPSULE, LIQUID FILLED [AUROHEALTH LLC]2Current NDC, 10 package rows20241025_a057241d-a655-4847-9d2d-d45293f45d87.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-81858602-818-83, 58602-818-67, 58602-818-84, 58602-818-08, 58602-818-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
GELATIN TYPE B BOVINE (160 BLOOM)1T8387508XIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
ISOPROPYL ALCOHOLND2M416302IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
A211900-001LORATADINELORATADINE10MGCAPSULE / ORAL2023-03-24

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 22:38:342026-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2484e616aacf4f…
2026-08-18 06:07:402026-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-248072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211900-001LORATADINE10MGCAPSULE / ORAL2023-03-24a50c72e98297…

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
LoratadineLORATADINEAurohealth LLCa057241d-a655-4847-9d2d-d45293f45d872024-10-23WarningsExact identifier
ndc (package): 58602-818-08
ndc (package): 58602-818-84
ndc (package): 58602-818-67
ndc (package): 58602-818-83
ndc (package): 58602-818-05
ndc (product): 58602-818
ndc11 (package): 58602081808
ndc11 (package): 58602081805
ndc11 (package): 58602081884
ndc11 (package): 58602081867
ndc11 (package): 58602081883
spl id: cfa8d72c-3d1a-464c-b63a-b7b7525c1a3c
spl set id: a057241d-a655-4847-9d2d-d45293f45d87

Reported adverse events (FAERS/openFDA)#

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