LORATADINE

Manufacturer: KROGER COMPANY | TIME CAP LABORATORIES INC | MARKSANS PHARMA LIMITED
Effective date: 2025-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:28:57

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 description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
828269	loratadine 10 MG 24HR Oral Capsule	PSN	3
828269	loratadine 10 MG Oral Capsule	SCD	3
828269	loratadine 10 MG 24HR Oral Capsule	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41226-686-30	2025-12-29	C162847	48780-1	2cef2736-899c-d83d-e063-dadaa90ab31f	KROGER 686T
41226-686-30	2025-01-30	C162847	48780-1	2cef2736-899c-d83d-e063-dadaa90ab31f	KROGER 686T

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41226-686-30	LORATADINE	30 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	30		3

Products#

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

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

LORATADINE
FD&C BLUE NO. 1
GELATIN
POLYSORBATE 80
POVIDONE
WATER
SORBITOL
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41226-686	41226-686-30

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
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE	FZ989GH94E	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	U72Q2I8C85	IACT
LORATADINE	7AJO3BO7QN	ACTIB

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206214-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2016-09-23

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206214-001	LORATADINE	10MG	CAPSULE / ORAL	2016-09-23	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LORATADINE	LORATADINE	KROGER COMPANY	0599cc64-419d-452f-ac50-ac0311006729	2025-12-29	Warnings	Exact identifier ndc (package): 41226-686-30 ndc (product): 41226-686 ndc11 (package): 41226068630 spl id: 4716c66e-ed8d-11bd-e063-6294a90a685c spl set id: 0599cc64-419d-452f-ac50-ac0311006729

Reported adverse events (FAERS/openFDA)#

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