FDA.reportPublic FDA data

LORATADINE

Manufacturer
TIME CAP LABORATORIES INC | MARKSANS PHARMA LIMITED
Effective date
2018-05-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:55:42

Label at a glance#

ProductLORATADINE
Active ingredientLORATADINE
Label structure9 sections

Storage and handling

STORE BETWEEN  20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) PROTECT FROM FREEZING

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

LORATADINE 10MG

WARNINGS SECTION

DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.

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.

OTC - PURPOSE SECTION

ANTIHISTAMINE

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:

RUNNY NOSE

ITCHY, WATERY EYES

SNEEZING

ITCHING OF THE NOSE OR THROAT

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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.

STORAGE AND HANDLING SECTION

STORE BETWEEN  20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)

PROTECT FROM FREEZING

INACTIVE INGREDIENT SECTION

FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN4
828269loratadine 10 MG Oral CapsuleSCD4
828269loratadine 10 MG 24HR Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-686-07LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
49483-686-30LORATADINE30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-686LORATADINE CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20180529_85b26cf3-448c-4d4f-93a2-aa89530ec1f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-686-07EA - Each49483-686e60e257f-7baf-4886-a4b3-5e240352db5612017-04-05
49483-686-30EA - Each49483-68628975a14-17ca-4f1f-a9c2-ae5cb32b87d312017-04-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-68649483-686-07, 49483-686-30

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
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESU72Q2I8C85IACT
LORATADINE7AJO3BO7QNACTIB

Source Document#

Source XML · Source PDF

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
A206214-001LORATADINELORATADINE10MGCAPSULE / ORAL2016-09-23

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 13:18:302026-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23c2088c7a36db…
2026-09-14 22:38:342026-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2384e616aacf4f…
2026-08-18 06:07:402026-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f01610625f2…
2019-09-15 20:21 UTC2019-09A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206214-001LORATADINE10MGCAPSULE / ORAL2016-09-233a93d1ddd44b…

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
LORATADINELORATADINETIME CAP LABORATORIES INC85b26cf3-448c-4d4f-93a2-aa89530ec1f12018-05-16WarningsExact identifier
ndc (package): 49483-686-30
ndc (package): 49483-686-07
ndc (product): 49483-686
ndc11 (package): 49483068607
ndc11 (package): 49483068630
spl id: 6c562c37-86ca-42c2-e053-2a91aa0a8a8a
spl set id: 85b26cf3-448c-4d4f-93a2-aa89530ec1f1

Reported adverse events (FAERS/openFDA)#

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