Loratadine

Product NDC: 21130-042
11-digit product format: 211300042
Labeler code: 21130
Product ID: 21130-042_b0412b0b-32e8-49a6-b62a-717290693d7e
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Better Living Brands LLC
Application: ANDA208931
Marketing category: ANDA
Marketing start: 2023-09-25
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
A208931-001	LORATADINE	LORATADINE	1MG/ML	SYRUP / ORAL			2018-06-29

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	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208931-001	LORATADINE	1MG/ML	SYRUP / ORAL	2018-06-29	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine
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
f7dc7a3d-6709-d7e7-e053-6394a90acde8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-042-24	Loratadine	120 mL in 1 BOTTLE	SOLUTION	120		2
21130-042-24	Loratadine	1 in 1 CARTON	SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-042	LORATADINE (LORATADINE ORAL) SOLUTION [BETTER LIVING BRANDS LLC]	2	Current NDC, 2 package rows	20230927_f7dc7a3d-6709-d7e7-e053-6394a90acde8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine	LORATADINE ORAL	KROGER COMPANY	b963d83b-584f-c447-e053-2995a90ad973	2026-07-06	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931
Loratadine	LORATADINE ORAL	BluePoint Laboratories	ab820f80-b5fc-7896-e053-2995a90a4b1c	2025-05-15	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931
Loratadine	LORATADINE ORAL	Aurohealth LLC	0b86a9fe-db7e-470a-a8fa-d7d4373116ba	2025-01-20	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931
Loratadine	LORATADINE ORAL	Better Living Brands LLC	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2023-09-26	Warnings	Exact identifier application applno (ANDA): 208931 application number: ANDA208931 ndc (product): 21130-042

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	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2
692783	loratadine 1 MG/ML Oral Solution	SCD	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2
692783	loratadine 5 MG per 5 ML Oral Solution	SY	f7dc7a3d-6709-d7e7-e053-6394a90acde8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21130-042-24	21130004224	1 BOTTLE in 1 CARTON (21130-042-24) / 120 mL in 1 BOTTLE	1 bottle	2023-09-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loratadine Oral Solution USP 5 mg/5 mL	Better Living Brands LLC \| Aurohealth LLC \| Aurobindo Pharma Limited	2023-09-26	Human OTC Drug Label	2