Ibuprofen and Pseudoephedrine HCl

Product NDC: 58602-803
11-digit product format: 586020803
Labeler code: 58602
Product ID: 58602-803_08c50304-67d6-4733-84e4-5a686afa04f3
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen and Pseudoephedrine HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA209235
Marketing category: ANDA
Marketing start: 2017-12-01
Substance: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 200; 30 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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 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
A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL			2017-12-01

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	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209235-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	2017-12-01	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen and Pseudoephedrine HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1299018	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
6adf9292-b4af-4cb4-99f3-dda03734570a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
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
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	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	SPL version
58602-803-03	Ibuprofen and Pseudoephedrine HCl	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	6
58602-803-08	Ibuprofen and Pseudoephedrine HCl	4 in 1 CARTON	CAPSULE, LIQUID FILLED	4	6
58602-803-13	Ibuprofen and Pseudoephedrine HCl	4 in 1 CARTON	CAPSULE, LIQUID FILLED	4	6
58602-803-67	Ibuprofen and Pseudoephedrine HCl	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	6
58602-803-79	Ibuprofen and Pseudoephedrine HCl	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8	6
58602-803-83	Ibuprofen and Pseudoephedrine HCl	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-803	IBUPROFEN AND PSEUDOEPHEDRINE HCL CAPSULE, LIQUID FILLED [AUROHEALTH LLC]	6	Current NDC, Legacy NDC, 6 package rows	20220208_6adf9292-b4af-4cb4-99f3-dda03734570a.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	06dd551b-6e13-425c-8d64-8d3177adc6bc	2026-06-16	Warnings	Exact identifier application applno (ANDA): 209235 application number: ANDA209235
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	WALGREEN CO.	1cc6e3f0-64f7-4974-a62c-5db46ca9e7c5	2023-09-08	Warnings	Exact identifier application applno (ANDA): 209235 application number: ANDA209235
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	CVS Pharmacy, Inc.	b8a4d9be-e202-4f99-bece-e2125aaca8b9	2023-07-14	Warnings	Exact identifier application applno (ANDA): 209235 application number: ANDA209235
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	Amerisource Bergen	8d397f4f-ac5e-426d-a26b-ee064b6e5028	2022-11-04	Warnings	Exact identifier application applno (ANDA): 209235 application number: ANDA209235
Ibuprofen and Pseudoephedrine HCl	IBUPROFEN AND PSEUDOEPHEDRINE HCL	Aurohealth LLC	6adf9292-b4af-4cb4-99f3-dda03734570a	2022-01-21	Warnings	Exact identifier application applno (ANDA): 209235 application number: ANDA209235 ndc (product): 58602-803

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1299018	ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Capsule	PSN	6adf9292-b4af-4cb4-99f3-dda03734570a	6
1299018	ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Capsule	SCD	6adf9292-b4af-4cb4-99f3-dda03734570a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-803-03	58602080303	1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)	1 blister pack	2020-01-17	0000-00-00	No	No	Current
58602-803-08	58602080308	4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)	4 blister pack	2017-12-01	0000-00-00	No	No	Current
58602-803-13	58602080313	4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79)	4 blister pack	2017-12-01	0000-00-00	No	No	Current
58602-803-67	58602080367	2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)	2 blister pack	2017-12-01	0000-00-00	No	No	Current
58602-803-79	58602080379	8 in 1 BLISTER PACK						Historical
58602-803-83	58602080383	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg	Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2022-01-21	Human OTC Drug Label	6