Loratadine

Product NDC: 37205-378
11-digit product format: 372050378
Labeler code: 37205
Product ID: 37205-378_50612f6b-c83f-451b-a2c0-09d9a542718f
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: Cardinal Health
Application: ANDA076805
Marketing category: ANDA
Marketing start: 2004-08-20
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 5 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	37205-378		D	Discontinued by firm		2026-08-03
excluded package	package	37205-378	37205-378-26	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-378-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-378-26	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076805-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2004-08-20

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076805-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-378-26	ML - Milliliter	37205-378	17460fcc-28b7-44e7-9c61-3fa4895820e9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Loratadine	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE SOLUTION [CARDINAL HEALTH]	1
Loratadine	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE SOLUTION [CARDINAL HEALTH]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	LORATADINE SOLUTION [CARDINAL HEALTH]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	LORATADINE SOLUTION [CARDINAL HEALTH]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LORATADINE SOLUTION [CARDINAL HEALTH]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	LORATADINE SOLUTION [CARDINAL HEALTH]	1
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	LORATADINE SOLUTION [CARDINAL HEALTH]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LORATADINE SOLUTION [CARDINAL HEALTH]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LORATADINE SOLUTION [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37205-378	LORATADINE SOLUTION [CARDINAL HEALTH]	3	Legacy NDC	20241019_6f881bd5-14c4-4077-ad03-1fae2d6ccb3b.zip

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	12c8066a-3429-481e-b63a-7ea2b439a170	2026-07-14	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine	LORATADINE	Sun Pharmaceutical Industries, Inc.	78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0	2026-04-08	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Preferred Pharmaceuticals Inc.	23936948-71bf-4c18-9160-22b7075e675d	2026-01-15	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Walgreen Company	42a73448-104a-4c7f-aea0-cef44d15f5f1	2026-01-13	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	H E B	d710b760-794e-490b-a413-c7b2ee5149b9	2025-08-14	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	STRATEGIC SOURCING SERVICES LLC	809456dc-1d1c-42a7-b17f-e43dacde927f	2025-07-30	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Loratadine	LORATADINE	STRATEGIC SOURCING SERVICES LLC	6ba7fc5d-81c4-482c-8b38-4a6587853a9f	2025-07-21	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
childrens allergy	LORATADINE	Publix Super Markets Inc	fa429380-019e-4ccd-8444-d5d931c4cc65	2025-07-15	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	Sun Pharmaceutical Industries, Inc.	58eaab62-ac36-4080-8ded-9b472dddc617	2025-07-02	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Sunmark childrens loratadine	LORATADINE	Strategic Sourcing Services LLC	ed94cba7-c2c4-4cbe-9021-f554a51d51f2	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine	LORATADINE	Strategic Sourcing Services LLC	280739e5-94e5-4d1e-ba65-2b4304cbac97	2024-12-19	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Childrens Loratadine Sugar Free	LORATADINE	American Sales Company	6977d7e0-9d01-4f5e-8d55-98dabb719585	2024-12-09	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Loratadine	LORATADINE	Cardinal Health, 110 dba LEADER	db9d2182-6bf1-424a-a144-f2694c47989f	2021-06-23	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Good Neighbor Pharmacy Childrens Loratadine	LORATADINE	AmerisourceBergen	3ffc656a-90f9-4921-9c4f-840023b98433	2020-06-24	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805
Good Neighbor Pharmacy Childrens Loratadine	LORATADINE	AmerisourceBergen	22d0714b-c1fe-4e77-92d8-aed3284813b4	2020-06-23	Warnings	Exact identifier application applno (ANDA): 076805 application number: ANDA076805

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37205-378-26	37205037826	1 BOTTLE in 1 CARTON (37205-378-26) > 120 mL in 1 BOTTLE	1 bottle	2004-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Oral Solution, 5 mg/5 mL	Cardinal Health \| Taro Pharmaceutical Industries Ltd.	2024-10-17	HUMAN OTC DRUG LABEL	3