Childrens Loratadine Oral

Product NDC: 81646-106
11-digit product format: 816460106
Labeler code: 81646
Product ID: 81646-106_7ebdeef4-208a-4aff-9b86-4506dd9a08aa
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: SOLUTION
Route: ORAL
Labeler: PINNACLE PHARMA LLC
Application: ANDA075728
Marketing category: ANDA
Marketing start: 2019-02-12
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 5 mg/5mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	81646-106		I	Inactivated by FDA		2026-08-17
excluded package	package	81646-106	81646-106-05	I	Inactivated by FDA		2026-08-17

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 · 30 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	81646-106-05	`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	81646-106-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81646-106-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81646-106-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81646-106-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81646-106-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81646-106-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81646-106-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81646-106-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	81646-106-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	81646-106-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	81646-106-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	81646-106-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	81646-106-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	81646-106-05	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81646-106-05	2023-01-30	C162847	48780-1	f386c64a-0eb4-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Children’s Loratadine Oral Solution Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81646-106-05	Childrens Loratadine Oral	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81646-106	CHILDRENS LORATADINE ORAL (LORATADINE) SOLUTION [PINNACLE PHARMA LLC]	5	Legacy NDC, 1 package rows	20210515_77a4eae9-695f-49fb-82e0-f05b7cf7391e.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81646-106-05	81646010605	5 mL in 1 CUP, UNIT-DOSE (81646-106-05)	5 ml	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	PINNACLE PHARMA LLC	2021-04-02	HUMAN OTC DRUG LABEL	5