Childrens Loratadine

Product NDC: 46122-423
11-digit product format: 461220423
Labeler code: 46122
Product ID: 46122-423_f8905ca0-2fa9-422e-a42d-7d2b99a07775
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: AmerisourceBergen
Application: ANDA076805
Marketing category: ANDA
Marketing start: 2017-03-17
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	46122-423		I	Inactivated by FDA		2026-08-03
excluded package	package	46122-423	46122-423-26	I	Inactivated by FDA		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	46122-423-26	`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	46122-423-26	`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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
46122-423-26	2025-07-29	C162847	48780-1	3b156c62-2803-fb37-e063-e6dba90a4e07	Children's Loratadine Oral Solution Sugar Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-423-26	Childrens Loratadine Sugar Free	1 in 1 CARTON	SOLUTION	1		1
46122-423-26	Childrens Loratadine Sugar Free	120 mL in 1 BOTTLE	SOLUTION	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-423-26	ML - Milliliter	46122-423	521b40fc-24ae-4a95-82f7-5323a9f995bb	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-423	CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [AMERISOURCEBERGEN]	1	Legacy NDC, 2 package rows	20171219_311733b1-7de7-486d-bb63-5d6933f0d543.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	311733b1-7de7-486d-bb63-5d6933f0d543	1
692783	loratadine 1 MG/ML Oral Solution	SCD	311733b1-7de7-486d-bb63-5d6933f0d543	1
692783	loratadine 5 MG per 5 ML Oral Solution	SY	311733b1-7de7-486d-bb63-5d6933f0d543	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-423-26	46122042326	1 BOTTLE in 1 CARTON (46122-423-26) > 120 mL in 1 BOTTLE	1 bottle	2017-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Loratadine Oral Solution Sugar Free	AmerisourceBergen	2017-12-15	HUMAN OTC DRUG LABEL	1