Childrens Loratadine Oral

Product NDC: 0904-6767
11-digit product format: 009046767
Labeler code: 0904
Product ID: 0904-6767_efdb406d-9562-4ed6-b461-683c82e26a73
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075728
Marketing category: ANDA
Marketing start: 2019-02-12
Substance: LORATADINE
Active strength: 5 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075728-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075728-001	LORATADINE	1MG/ML	SYRUP / ORAL	2004-08-20	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Loratadine Oral
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692783	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f0f0131-b516-4ff3-8049-3d3766324b66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6767-20	Childrens Loratadine Oral	120 mL in 1 BOTTLE	SOLUTION	120		4
0904-6767-20	Childrens Loratadine Oral	1 in 1 CARTON	SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6767-20	ML - Milliliter	0904-6767	500c2e66-eb62-4241-8b42-e16796e0aa79	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6767	CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20250507_3f0f0131-b516-4ff3-8049-3d3766324b66.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens allergy relief	LORATADINE	Kroger Company	52934db1-b6fc-43ca-9a8c-66ff47a94745	2026-06-29	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Good Sense childrens allergy relief	LORATADINE	Preferred Pharmaceuticals Inc.	27bb0a40-35ee-4c19-bd6f-fb054c8a2586	2026-05-28	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Childrens Loratadine Oral	LORATADINE	A-S Medication Solutions	0a42baae-554b-4b93-8780-fe45c42fabc0	2026-03-18	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
CHILDRENS ALLERGY RELIEF	LORATADINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0e84571d-87b6-4742-ac62-9ed68a115c72	2026-03-17	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Childrens Loratadine Oral	LORATADINE	Atlantic Biologicals	4a1a6981-133c-d45b-e063-6294a90a4a09	2026-02-05	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Childrens Loratadine Oral	LORATADINE	Major Pharmaceuticals	3f0f0131-b516-4ff3-8049-3d3766324b66	2025-11-13	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728 ndc (product): 0904-6767
Good Sense childrens allergy relief	LORATADINE	NuCare Pharmaceuticals,Inc.	40d25cdf-b63f-d5c9-e063-6394a90af509	2025-10-10	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
basic care childrens allergy relief	LORATADINE	Amazon.com Services LLC	90f40330-46a6-44cf-9b09-6f791c9b210b	2025-05-12	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Equaline Childrens Allergy Relief	LORATADINE	United Natural Foods, Inc. dba UNFI	11e889d8-833c-4043-a1af-7ffaf3fda61d	2025-05-07	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
dg health childrens allergy	LORATADINE	Dolgencorp, LLC	14acf572-e1f0-40f5-82cf-357cb2f3a051	2025-05-07	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
good sense childrens allergy relief	LORATADINE	L. Perrigo Company	4ce244e2-9fbc-4371-8806-789fd3a61a09	2025-05-06	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
childrens allergy relief	LORATADINE	Meijer, Inc.	f71d9155-e5fb-4735-86f6-59dd9abf6be0	2025-05-05	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
equate childrens allergy	LORATADINE	Wal-Mart Stores Inc	5603d5e1-8d95-44b9-aceb-4bc37b162ab1	2025-05-05	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
childrens allergy relief	LORATADINE	Rite Aid Corporation	539336e6-7979-47ed-b1ea-fd46ef547aee	2025-05-05	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Good Sense childrens allergy relief	LORATADINE	L. Perrigo Company	637e309d-9846-45a1-ad11-f67ea85c87b8	2025-05-05	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
good neighbor pharmacy childrens loratadine	LORATADINE	Amerisource Bergen	46cdccaf-a6f2-4a49-a2b0-7ba0df17bfa8	2024-11-19	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
UP AND UP CHILDRENS ALLERGY	LORATADINE	Target Corporation	a9f6ae02-cf29-4111-99e7-7e6b1ecb88f0	2024-07-31	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
Childrens Allergy	LORATADINE	CVS Pharmacy	13c40819-24af-48f1-8371-9e32dc5339a1	2024-07-26	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
welby childrens allergy relief	LORATADINE	Aldi Inc	402c635d-4116-4767-baa9-e956fed02884	2022-09-26	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728
topcare childrens allergy	LORATADINE	Topco Associates LLC	6e175fae-05dd-45c2-b9ab-7d49369a3c05	2022-02-28	Warnings	Exact identifier application applno (ANDA): 075728 application number: ANDA075728

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	77a4eae9-695f-49fb-82e0-f05b7cf7391e	5
692783	loratadine 1 MG/ML Oral Solution	SCD	77a4eae9-695f-49fb-82e0-f05b7cf7391e	5
692783	loratadine 5 MG per 5 ML Oral Solution	SY	77a4eae9-695f-49fb-82e0-f05b7cf7391e	5
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	3f0f0131-b516-4ff3-8049-3d3766324b66	4
692783	loratadine 1 MG/ML Oral Solution	SCD	3f0f0131-b516-4ff3-8049-3d3766324b66	4
692783	loratadine 5 MG per 5 ML Oral Solution	SY	3f0f0131-b516-4ff3-8049-3d3766324b66	4
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	0a42baae-554b-4b93-8780-fe45c42fabc0	3
692783	loratadine 1 MG/ML Oral Solution	SCD	0a42baae-554b-4b93-8780-fe45c42fabc0	3
692783	loratadine 5 MG per 5 ML Oral Solution	SY	0a42baae-554b-4b93-8780-fe45c42fabc0	3
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	4a1a6981-133c-d45b-e063-6294a90a4a09	1
692783	loratadine 5 MG in 5 mL Oral Solution	PSN	e4b9acaf-ebf6-a925-e053-2a95a90a060b	1
692783	loratadine 1 MG/ML Oral Solution	SCD	4a1a6981-133c-d45b-e063-6294a90a4a09	1
692783	loratadine 1 MG/ML Oral Solution	SCD	e4b9acaf-ebf6-a925-e053-2a95a90a060b	1
692783	loratadine 5 MG per 5 ML Oral Solution	SY	4a1a6981-133c-d45b-e063-6294a90a4a09	1
692783	loratadine 5 MG per 5 ML Oral Solution	SY	e4b9acaf-ebf6-a925-e053-2a95a90a060b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6767-20	00904676720	1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLE	1 bottle	2019-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts	A-S Medication Solutions	2026-03-18	HUMAN OTC DRUG LABEL	3
Children’s Loratadine Oral Solution Drug Facts	Atlantic Biologicals	2026-02-05	HUMAN OTC DRUG LABEL	1
Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts	Major Pharmaceuticals	2025-11-13	HUMAN OTC DRUG LABEL	4
Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts	NuCare Pharmaceuticals,Inc.	2022-07-26	HUMAN OTC DRUG LABEL	1
Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts	PINNACLE PHARMA LLC	2021-04-02	HUMAN OTC DRUG LABEL	5