allergy and congestion relief

Product NDC: 11822-1019
11-digit product format: 118221019
Labeler code: 11822
Product ID: 11822-1019_04772dfa-6b49-4df3-9898-16c7d6738923
Type: HUMAN OTC DRUG
Nonproprietary name: loratadine, Pseudoephedrine sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA076050
Marketing category: ANDA
Marketing start: 2018-06-06
Marketing end: 0000-00-00
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 5 mg/1; mg/1
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	11822-1019		D	Discontinued by firm		2026-09-09
excluded package	package	11822-1019	11822-1019-1	D	Discontinued by firm		2026-09-09

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	11822-1019		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11822-1019	11822-1019-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2003-01-30

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	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076050-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2003-01-30	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-1019	ALLERGY AND CONGESTION RELIEF (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RITE AID CORPORATION]	3	Legacy NDC	20210114_c2b3b2f6-cae0-48f1-abdb-eeb385c85c11.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy and nasal congestion	LORATADINE, PSEUDOEPHEDRINE SULFATE	Kroger Company	934dda74-7995-46f1-b6f2-f4b928a2eeb2	2026-07-08	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d 12	LORATADINE, PSEUDOEPHEDRINE SULFATE	Walgreen Company	7e6ea563-cc79-4683-b600-0691e0fb78ab	2026-04-09	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d 12	LORATADINE, PSEUDOEPHEDRINE SULFATE	CVS Pharmacy	0ca2b074-7137-478c-b32c-67f834f6c454	2026-03-15	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
loratadine D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Sportpharm LLC	bb54f613-b2ab-48fd-83c9-2038ec7097f6	2026-02-06	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
good neighbor pharmacy loratadine d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Amerisource Bergen	90b0a155-b92c-45e3-959f-8f21065d31dd	2025-09-12	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
equate allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Wal-Mart Stores Inc	306e8736-b27f-4445-b613-3e5b609f8d42	2025-07-17	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
foster and thrive allergy D 12 hour	LORATADINE, PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	4626e3ca-d3e9-46ad-9c53-66d27c82aed7	2025-06-13	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Meijer Distribution Inc	dd19215c-0da7-483a-88e3-6a32ac210c4c	2025-05-28	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
loratadine D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Padagis Israel Pharmaceuticals Ltd	01e61c73-3b81-4683-b1a9-8784c0d565b1	2025-03-03	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Allergy and Congestion Relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	L. Perrigo Company	b5589371-48bc-44a5-bcab-018a92e22796	2024-02-26	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Allergy Relief D	LORATADINE, PSEUDOEPHEDRINE SULFATE	Rite Aid Corporation	f08ebf00-a1d7-4a6f-a84f-195d000de53d	2024-02-16	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
kirkland signature allerclear d 12 hr	LORATADINE, PSEUDOEPHEDRINE SULFATE	Costco Wholesale Company	1534720b-f8f8-4db5-99e0-cfa49acf9299	2023-07-07	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
topcare allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Topco Associates LLC	dd93d172-2a3a-4e4c-a237-7668acbd537d	2022-02-16	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Alavert Allergy and Congestion D-12 hour	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Foundation Consumer Brands	1a669f3c-36a6-439e-843d-47638fa217e8	2021-12-07	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
perrigo allergy d	LORATADINE, PSEUDOEPHEDRINE SULFATE	L. Perrigo Company	955c9f49-38af-4b48-b325-60fa94bfe60b	2021-10-08	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
Leader Allergy Relief D12	LORATADINE, PSEUDOEPHEDRINE SULFATE	Cardinal Health 110, LLC. dba Leader	98bd6186-2bd2-4f46-99df-f509bb00e03a	2021-06-17	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
signature care allergy and congestion relief	LORATADINE, PSEUDOEPHEDRINE SULFATE	Safeway	e1993d05-248e-48da-838c-068f8263c2eb	2021-03-08	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050
allergy relief d	LORATADINE, PSEUDOEPHEDRINE SULFATE	Publix Super Markets Inc	8209d7d5-4ecc-4170-ba50-5917bd8c46d4	2020-10-19	Warnings	Exact identifier application applno (ANDA): 076050 application number: ANDA076050

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-1019-1	11822101901	30 BLISTER PACK in 1 CARTON (11822-1019-1) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	30 blister pack	2018-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Allergy & Congestion Relief Drug Facts	Rite Aid Corporation	2021-01-13	HUMAN OTC DRUG LABEL	3