Allergy Relief

Product NDC: 69168-309
Requested package NDC: 69168-309-10
11-digit product format: 691680309
Labeler code: 69168
Product ID: 69168-309_520a7a7c-a1a5-48a6-b472-9d47a4463452
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: ANDA076471
Marketing category: ANDA
Marketing start: 2014-12-16
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69168-309	69168-309-10	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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A076471-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2006-02-14

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	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1

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
311372	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
0991388a-2eb8-4913-9efc-adf411eddf3a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69168-309-08	2020-03-13	309 - Health A2Z Allergy Relief
69168-309-09	2020-03-13	309 - Health A2Z Allergy Relief
69168-309-10	2020-03-13	309 - Health A2Z Allergy Relief
69168-309-30	2020-03-13	309 - Health A2Z Allergy Relief
69168-309-08	2020-01-31	309 - Health A2Z Allergy Relief
69168-309-09	2020-01-31	309 - Health A2Z Allergy Relief
69168-309-10	2020-01-31	309 - Health A2Z Allergy Relief
69168-309-30	2020-01-31	309 - Health A2Z Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-309-03	Allergy Relief	30 in 1 BLISTER PACK	TABLET	30	6
69168-309-08	Allergy Relief	5 in 1 BLISTER PACK	TABLET	5	6
69168-309-08	Allergy Relief	1 in 1 CARTON	TABLET	1	6
69168-309-09	Allergy Relief	10 in 1 BLISTER PACK	TABLET	10	6
69168-309-09	Allergy Relief	1 in 1 CARTON	TABLET	1	6
69168-309-10	Allergy Relief	1000 in 1 BOTTLE	TABLET	1000	6
69168-309-30	Allergy Relief	1 in 1 CARTON	TABLET	1	6
69168-309-30	Allergy Relief	30 in 1 BOTTLE	TABLET	30	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-309	ALLERGY RELIEF (LORATADINE) TABLET [ALLEGIANT HEALTH]	6	Current NDC, Legacy NDC, 8 package rows	20241206_0991388a-2eb8-4913-9efc-adf411eddf3a.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	Apotex Corp.	679164cc-7505-7ed4-13fe-87f06cb777d8	2025-09-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Non-Drowsy Allergy Relief	LORATADINE TABLET	Lil' Drug Store Products, Inc.	031fc3e5-b5eb-447c-e063-6294a90a13b5	2023-08-17	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471
Allergy Relief	LORATADINE	Allegiant Health	0991388a-2eb8-4913-9efc-adf411eddf3a	2018-11-08	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471 ndc (package): 69168-309-10 ndc (product): 69168-309 ndc11 (package): 69168030910
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier application applno (ANDA): 076471 application number: ANDA076471

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
311372	loratadine 10 MG 24HR Oral Tablet	PSN	0991388a-2eb8-4913-9efc-adf411eddf3a	6
311372	loratadine 10 MG Oral Tablet	SCD	0991388a-2eb8-4913-9efc-adf411eddf3a	6
311372	loratadine 10 MG 24 HR Oral Tablet	SY	0991388a-2eb8-4913-9efc-adf411eddf3a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-309-10	69168030910	1000 TABLET in 1 BOTTLE (69168-309-10)	1000 tablet	2014-12-16	0000-00-00	No	No	Current