FDA.reportPublic FDA data

Loratadine Tablets USP 10 mg

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2020-08-13
Label type
Human OTC Drug Label
Version
10
Source
full-release
Hydrated at
2026-05-31 23:24:38

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure16 sections

Indications and 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

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

Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken store at 20° to 25°C (68° to 77°F) protect from excessive moisture

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                                                                    
  • itchy, watery eyes
  • sneezing 
  • 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 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


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION


call 1-855-274-4122
Distributed by: AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
 Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-702-17
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine

24 Hour
Relief of:

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

Indoor & Outdoor
Allergies
*When taken as directed.
See Drug Facts Panel.             45 Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-702-17
#Compare to the active
ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

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

*When taken as directed
See Drug Facts Panel.             45 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-702-84
#Compare to the active
ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

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

*When taken as directed.
See Drug Facts Panel.
30 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN10
311372loratadine 10 MG Oral TabletSCD10
311372loratadine 10 MG 24 HR Oral TabletSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-702-04Loratadine10 in 1 CARTONTABLET1010
58602-702-04Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-05Loratadine5 in 1 CARTONTABLET510
58602-702-05Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-09Loratadine30 in 1 BOTTLETABLET3010
58602-702-09Loratadine1 in 1 CARTONTABLET110
58602-702-15Loratadine1 in 1 CARTONTABLET110
58602-702-15Loratadine60 in 1 BOTTLETABLET6010
58602-702-17Loratadine45 in 1 BOTTLETABLET4510
58602-702-17Loratadine1 in 1 CARTONTABLET110
58602-702-19Loratadine1 in 1 CARTONTABLET110
58602-702-19Loratadine90 in 1 BOTTLETABLET9010
58602-702-21Loratadine100 in 1 BOTTLETABLET10010
58602-702-21Loratadine1 in 1 CARTONTABLET110
58602-702-23Loratadine120 in 1 BOTTLETABLET12010
58602-702-23Loratadine1 in 1 CARTONTABLET110
58602-702-29Loratadine1 in 1 CARTONTABLET110
58602-702-29Loratadine150 in 1 BOTTLETABLET15010
58602-702-32Loratadine1 in 1 CARTONTABLET110
58602-702-32Loratadine180 in 1 BOTTLETABLET18010
58602-702-38Loratadine1 in 1 CARTONTABLET110
58602-702-38Loratadine300 in 1 BOTTLETABLET30010
58602-702-39Loratadine365 in 1 BOTTLETABLET36510
58602-702-39Loratadine1 in 1 CARTONTABLET110
58602-702-40Loratadine500 in 1 BOTTLETABLET50010
58602-702-40Loratadine1 in 1 CARTONTABLET110
58602-702-44Loratadine400 in 1 BOTTLETABLET40010
58602-702-44Loratadine1 in 1 CARTONTABLET110
58602-702-54Loratadine1 in 1 CARTONTABLET110
58602-702-54Loratadine70 in 1 BOTTLETABLET7010
58602-702-60Loratadine5 in 1 BLISTER PACKTABLET510
58602-702-60Loratadine1 in 1 CARTONTABLET110
58602-702-67Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-67Loratadine2 in 1 CARTONTABLET210
58602-702-81Loratadine108 in 1 BOTTLETABLET10810
58602-702-81Loratadine1 in 1 CARTONTABLET110
58602-702-83Loratadine10 in 1 BLISTER PACKTABLET1010
58602-702-83Loratadine1 in 1 CARTONTABLET110
58602-702-84Loratadine3 in 1 CARTONTABLET310
58602-702-84Loratadine10 in 1 BLISTER PACKTABLET1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-702LORATADINE TABLET [AUROHEALTH LLC]10Current NDC, Legacy NDC, 40 package rows20200814_196da80c-3dbb-40c7-ac93-8a57d6acb1c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-702-04EA - Each58602-702b6ac94a0-33aa-46a2-bb1e-9bbb2c54391712022-08-04
58602-702-19EA - Each58602-7020ded0720-6b00-4796-8465-9f3f355efc4c12020-09-14
58602-702-21EA - Each58602-70282ed1960-30d9-417b-ba0b-97ef0c55608312020-07-13
58602-702-38EA - Each58602-702df9c14d8-6672-4437-b3df-51ecda845ebb12024-04-05

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-70258602-702-17, 58602-702-15, 58602-702-19, 58602-702-81, 58602-702-32, 58602-702-60, 58602-702-83, 58602-702-67, 58602-702-84, 58602-702-05, 58602-702-09, 58602-702-38, 58602-702-39, 58602-702-44, 58602-702-54, 58602-702-23, 58602-702-40, 58602-702-21, 58602-702-04, 58602-702-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…

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 LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsExact identifier
ndc (package): 58602-702-81
ndc (package): 58602-702-04
ndc (package): 58602-702-32
ndc (package): 58602-702-40
ndc (package): 58602-702-23
ndc (package): 58602-702-39
ndc (package): 58602-702-09
ndc (package): 58602-702-05
ndc (package): 58602-702-83
ndc (package): 58602-702-60
ndc (package): 58602-702-44
ndc (package): 58602-702-17
ndc (package): 58602-702-84
ndc (package): 58602-702-67
ndc (package): 58602-702-54
ndc (package): 58602-702-15
ndc (package): 58602-702-21
ndc (package): 58602-702-19
ndc (package): 58602-702-38
ndc (package): 58602-702-29
ndc (product): 58602-702
ndc11 (package): 58602070232
ndc11 (package): 58602070284
ndc11 (package): 58602070217
ndc11 (package): 58602070229
ndc11 (package): 58602070239
ndc11 (package): 58602070283
ndc11 (package): 58602070223
ndc11 (package): 58602070221
ndc11 (package): 58602070238
ndc11 (package): 58602070267
ndc11 (package): 58602070240
ndc11 (package): 58602070254
ndc11 (package): 58602070209
ndc11 (package): 58602070281
ndc11 (package): 58602070205
ndc11 (package): 58602070204
ndc11 (package): 58602070244
ndc11 (package): 58602070219
ndc11 (package): 58602070215
ndc11 (package): 58602070260
spl id: 94169799-0508-439b-93c5-132b9e6ae767
spl set id: 196da80c-3dbb-40c7-ac93-8a57d6acb1c3

Reported adverse events (FAERS/openFDA)#

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