Allergy Relief

Product NDC: 53943-116
11-digit product format: 539430116
Labeler code: 53943
Product ID: 53943-116_f1107c48-3f24-841d-e053-2995a90a6e68
Type: HUMAN OTC DRUG
Nonproprietary name: LORATADINE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: DISCOUNT DRUG MART, INC.
Application: ANDA202538
Marketing category: ANDA
Marketing start: 2021-08-20
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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	53943-116		I	Inactivated by FDA		2026-08-10
excluded package	package	53943-116	53943-116-13	I	Inactivated by FDA		2026-08-10

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53943-116-13	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53943-116-13	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53943-116-13	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53943-116-13	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53943-116-13	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53943-116-13	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53943-116-13	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53943-116-13	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53943-116-13	U	Excluded because listing certification expired	`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
A202538-001	LORATADINE	LORATADINE	10MG	CAPSULE / ORAL			2018-12-21

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	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202538-001	LORATADINE	10MG	CAPSULE / ORAL	2018-12-21	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-116-13	2025-01-30	C162847	48780-1	2cef2736-82e7-d83d-e063-dadaa90ab31f	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-116-13	Allergy Relief	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30		2
53943-116-13	Allergy Relief	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-116	ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [DISCOUNT DRUG MART, INC.]	2	Legacy NDC, 2 package rows	20221231_c9fbadd0-d623-3c1f-e053-2995a90a6247.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health allergy relief	LORATADINE	Dolgencorp Inc	086a0a53-7092-4dc8-9c5e-0bd78337fedf	2025-03-11	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
allergy relief	LORATADINE	Meijer, Inc.	14f3d1a2-eda7-432a-8fe0-5437b95bdde6	2025-02-14	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
topcare allergy relief	LORATADINE	Topco Associates LLC	5cc2e469-9080-4beb-804d-187fc335ccdc	2025-02-10	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
LORATADINE	LORATADINE	Bionpharma Inc.	4fa705fb-859e-4046-b153-a8338c50a97d	2024-12-23	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
Basic Care Allergy Relief	LORATADINE	Amazon.com Services LLC	2a834b33-5759-4e54-9adc-379310656dee	2020-08-19	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538
LORATADINE	LORATADINE	Bionpharma Inc.	59bebce3-2b82-4521-a796-2d4c83bcf669	2019-01-08	Warnings	Exact identifier application applno (ANDA): 202538 application number: ANDA202538

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
828269	loratadine 10 MG 24HR Oral Capsule	PSN	c9fbadd0-d623-3c1f-e053-2995a90a6247	2
828269	loratadine 10 MG Oral Capsule	SCD	c9fbadd0-d623-3c1f-e053-2995a90a6247	2
828269	loratadine 10 MG 24HR Oral Capsule	SY	c9fbadd0-d623-3c1f-e053-2995a90a6247	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-116-13	53943011613	1 BOTTLE in 1 CARTON (53943-116-13) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2021-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	DISCOUNT DRUG MART, INC. \| Bionpharma Inc. \| Patheon Softgels Inc.	2022-12-30	HUMAN OTC DRUG LABEL	2