Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold

Product NDC: 58602-816
11-digit product format: 586020816
Labeler code: 58602
Product ID: 58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium and Pseudoephedrine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA211360
Marketing category: ANDA
Marketing start: 2022-06-01
Substance: NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 220; 120 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 43.

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
A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2022-06-01

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211360-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-01	`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: Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	220 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	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
1367426	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
638a9664-4129-46fd-9ba1-d660a7366c9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
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
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	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
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-816-67	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	3
58602-816-67	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	3
58602-816-72	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	3
58602-816-72	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	8 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	8	3
58602-816-83	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	3
58602-816-83	Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-816	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND COLD (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AUROHEALTH LLC]	3	Current NDC, Legacy NDC, 6 package rows	20250304_638a9664-4129-46fd-9ba1-d660a7366c9f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	VESPYR BRANDS LLC	a973cb82-1e00-4706-8b96-648135ea48a1	2026-06-15	Warnings	Exact identifier application applno (ANDA): 211360 application number: ANDA211360
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	638a9664-4129-46fd-9ba1-d660a7366c9f	2025-02-12	Warnings	Exact identifier application applno (ANDA): 211360 application number: ANDA211360 ndc (product): 58602-816
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	10a8a74b-11d1-490e-87e7-d705fe0e7602	2025-01-21	Warnings	Exact identifier application applno (ANDA): 211360 application number: ANDA211360

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1367426	naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	638a9664-4129-46fd-9ba1-d660a7366c9f	3
1367426	12 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	638a9664-4129-46fd-9ba1-d660a7366c9f	3
1367426	naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	638a9664-4129-46fd-9ba1-d660a7366c9f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-816-67	58602081667	2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2022-06-01	0000-00-00	No	No	Current
58602-816-72	58602081672	3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2025-02-12		No	No	Current
58602-816-83	58602081683	1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2022-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold	Aurohealth LLC \| APL HEALTHCARE LIMITED	2025-02-12	Human OTC Drug Label	3