equate sinus and cold d

Product NDC: 49035-792
11-digit product format: 490350792
Labeler code: 49035
Product ID: 49035-792_0c4746b2-71d3-4269-81a2-3fb341e0bedb
Type: HUMAN OTC DRUG
Nonproprietary name: naproxen sodium, pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: ANDA076518
Marketing category: ANDA
Marketing start: 2020-07-24
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 220 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: 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49035-792		D	Discontinued by firm	2026-08-11
excluded product	product	49035-792		D	Discontinued by firm	2026-08-11
excluded package	package	49035-792	49035-792-01	D	Discontinued by firm	2026-08-11
excluded package	package	49035-792	49035-792-68	D	Discontinued by firm	2026-08-11
excluded package	package	49035-792	49035-792-89	D	Discontinued by firm	2026-08-11

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 · 46 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49035-792-68	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49035-792-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49035-792-89	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49035-792-68	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49035-792-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49035-792-89	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49035-792-68	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49035-792-89	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49035-792-68	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49035-792-89	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-792-68	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49035-792-89	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-792-68	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49035-792-89	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-792-68	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49035-792-89	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-792-68	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-792-89	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-792-68	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-792-89	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-792-68	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-792-89	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49035-792-68	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49035-792-89	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49035-792-68	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49035-792-89	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49035-792-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49035-792-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49035-792-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RS	2004-03-17

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG BASE;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG BASE;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49035-792-01	2022-10-12	C162847	48780-1	d6a99b39-b63b-a426-e053-dadaa90af4c2	Wal-Mart Sinus & Cold-D Drug Facts
49035-792-01	2022-01-28	C162847	48780-1	d6a99b39-b63b-a426-e053-dadaa90af4c2	Wal-Mart Sinus & Cold-D Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-792-01	EA - Each	49035-792	58156d12-6acb-4d84-b8f6-b1be5eee9e9a	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-792	EQUATE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WAL-MART STORES INC]	6	Legacy NDC	20250501_65d9ea11-4afb-4bdb-b9a2-78e12504e836.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex DS 12HR COLD, FEVER and SINUS	NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE	Reckitt Benckiser LLC	4e7e6674-c1ce-ea61-e063-6294a90afe04	2026-05-12	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Aleve-D Sinus and Headache	NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5ab980c0-c48a-233b-e053-2991aa0a4fd1	2025-12-04	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Aleve-D Sinus and Cold	NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE	Bayer HealthCare LLC.	599ea6c8-03ad-536e-e053-2991aa0a83a3	2025-12-04	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Leader All Day Sinus and Cold D	NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	83f7cfbb-ab84-4594-ae7a-4a657385c8a7	2025-04-25	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
All Day Sinus and Cold D	NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL	Walgreen Company	b0417ce5-3a5e-42cb-8672-9f2b133c91ca	2025-04-25	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Sinus and Cold D	NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	cb78330b-d8a3-4c16-bbb0-d31368a542e6	2025-04-18	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Topcare Sinus and Cold D	NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL	Topco Associates LLC	55c177ce-1729-4a9b-a5ae-2b6c96fbc27a	2025-04-17	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Sudafed Sinus 12 Hour Pressure plus Pain	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	305adca3-cdae-41e5-a10a-99d9dd0fe390	2024-11-08	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518
Sinus and Cold D	NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	9e142ac7-c8b1-449b-a224-c7db0fc0e4cf	2024-07-10	Warnings	Exact identifier application applno (ANDA): 076518 application number: ANDA076518

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-792-01	49035079201	20 BLISTER PACK in 1 CARTON (49035-792-01) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	20 blister pack	2020-07-24	0000-00-00	No	No	Current