Topcare Sinus and Cold D

Product NDC: 36800-417
11-digit product format: 368000417
Labeler code: 36800
Product ID: 36800-417_7cdb2600-a9fa-4fe8-9161-4f051bb1243b
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen sodium, Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA076518
Marketing category: ANDA
Marketing start: 2013-08-14
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-417	36800-417-52	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topcare Sinus and Cold D
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
55c177ce-1729-4a9b-a5ae-2b6c96fbc27a	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
36800-417-01	Topcare Sinus and Cold D	20 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	20	9
36800-417-01	Topcare Sinus and Cold D	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1	9
36800-417-52	Topcare Sinus and Cold D	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	9
36800-417-52	Topcare Sinus and Cold D	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-417	TOPCARE SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]	9	Current NDC, Legacy NDC, 4 package rows	20250425_55c177ce-1729-4a9b-a5ae-2b6c96fbc27a.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 ndc (product): 36800-417
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

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	55c177ce-1729-4a9b-a5ae-2b6c96fbc27a	9
1367426	12 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	55c177ce-1729-4a9b-a5ae-2b6c96fbc27a	9
1367426	naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	55c177ce-1729-4a9b-a5ae-2b6c96fbc27a	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-417-01	36800041701	20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	20 blister pack	2013-08-14	0000-00-00	No	No	Current
36800-417-52	36800041752	10 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Sinus & Cold-D Drug Facts	Topco Associates LLC	2025-04-17	HUMAN OTC DRUG LABEL	9