Loratadine and Pseudoephedrine Sulfate

Product NDC: 46122-167
11-digit product format: 461220167
Labeler code: 46122
Product ID: 46122-167_747b20a8-c3a3-45dd-9212-f5074a010c6c
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine and Pseudoephedrine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amerisource Bergen
Application: ANDA076557
Marketing category: ANDA
Marketing start: 2004-11-17
Substance: LORATADINE; PSEUDOEPHEDRINE SULFATE
Active strength: 10; 240 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 44.

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
A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL			2004-09-22

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076557-001	LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE / ORAL	2004-09-22	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Loratadine and Pseudoephedrine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LORATADINE	10 mg/1
PSEUDOEPHEDRINE SULFATE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7AJO3BO7QN	Internal UNII lookup
Y9DL7QPE6B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1117562	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
3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-167-52	Loratadine and Pseudoephedrine Sulfate	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-167-52	EA - Each	46122-167	a16d1aef-3296-46da-9063-34a4141ec732	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-167	LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	3	Current NDC, Legacy NDC, 1 package rows	20210609_3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1.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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	556b89ef-3b51-4faa-afb4-767a5c1b6422	2026-06-02	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Sportpharm LLC	2b432b67-f9f3-45e2-8306-2d4080152f99	2026-02-06	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
ALLERGY RELIEF-D	LORATADINE AND PSEUDOEPHEDRINE	CVS Pharmacy	0b26004d-f741-48e1-bf2b-ec4af8150160	2025-11-19	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Major Pharmaceuticals	2620a150-4a2c-4fa2-a0e4-6aafe9e496c3	2025-09-08	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Ohm Laboratories Inc.	bbe83464-a582-469f-8fac-f98e804d96fe	2025-07-15	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	The Kroger Company	43e53450-9630-4161-8008-22267a785343	2025-04-24	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	WAL-MART STORES, INC	59453133-20bf-4f13-855a-b47b22302d8b	2025-04-14	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	cdecad62-bf1e-43fb-b4be-8fc54b63e4ae	2024-11-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Strategic Sourcing Services LLC	48bfc938-d97d-4b49-8637-3b00ac870902	2024-11-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Meijer Distribution, Inc.	eb6e2196-2f4f-4fe9-9c80-b4ce89da8db4	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Release	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Kirkland-COSTCO WHOLESALE COMPANY	b8e35d9f-5ad7-4cd5-b359-18f7dfe586c6	2023-08-23	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	STRATEGIC SOURCING SERVICES LLC	07f03186-438d-41b7-a871-f05a38733329	2023-08-11	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Rite Aid	bb0f7653-378f-40b1-8ead-77999fcbd87b	2022-05-09	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Leader Allergy Relief D-24	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Cardinal Health	f1bcd2aa-e8cd-4364-87b4-c544537cdb50	2022-03-22	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Safeway Inc.	c1e1e0ca-30df-4ace-a7b6-c66a3c5ab676	2021-12-21	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Walgreen Company	ab7e4406-997a-43be-af99-a07a2da870da	2021-08-25	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	AMERISOURCE BERGEN	96635cb0-8c78-4c3a-8294-2804ff26f90a	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	Amerisource Bergen	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	2021-06-03	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557 ndc (product): 46122-167
Loratadine and Pseudoephedrine Sulfate	LORATADINE AND PSEUDOEPHEDRINE SULFATE	STRATEGIC SOURCING SERVICES	114b5e7c-973a-4a34-8538-a214de090b39	2020-07-30	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557
Loratadine and Pseudoephedrine	LORATADINE AND PSEUDOEPHEDRINE	Proficient Rx LP	ca1a6552-d082-4312-ba17-0055e8554eb9	2019-12-01	Warnings	Exact identifier application applno (ANDA): 076557 application number: ANDA076557

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1117562	pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet	PSN	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	3
1117562	24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet	SCD	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	3
1117562	loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet	SY	3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-167-52	46122016752	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-167-52)	2004-11-17	0000-00-00	No	No	Current