pseudoephedrine hydrochloride

Product NDC: 70518-1618
11-digit product format: 705181618
Labeler code: 70518
Product ID: 70518-1618_d9b8e6ed-89da-182c-e053-2a95a90a936e
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075153
Marketing category: ANDA
Marketing start: 2019-10-30
Marketing end: 0000-00-00
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-1618		D	Discontinued by firm		2026-08-03
excluded package	package	70518-1618	70518-1618-0	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-1618-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-1618-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-1618-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-1618-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-1618-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-1618-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-1618-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-1618-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-1618-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-1618-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-1618-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-1618-0	`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
A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		RS	1999-02-26

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	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL		1999-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075153-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1999-02-26	`cb3db0bc1861…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	HyVee Inc	8c4c786c-2b0f-4a23-a87d-effbcfe0c857	2026-06-15	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	06092347-33fe-46b8-829c-70e4ca15ecf2	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	a5aa414c-a143-44c8-9759-e84c0f032fbf	2026-04-01	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
leader 12 hour nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	8b8d374c-592e-44fc-a6cc-9f9e73ef914c	2026-02-25	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus and nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e39daa3c-1901-4966-b85e-ab76d7bd1216	2026-02-17	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
equate sinus 12 hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Wal-Mart Stores Inc	de65b99e-85e9-46c1-88b2-727c7ed8882a	2026-02-11	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
SudoGest 12 Hour	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	e829aab0-3ef0-4149-8197-96c5ce0b31d2	2025-10-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Good Sense Suphedrine 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	1de8a7f6-e7bb-437d-8794-c4b9f43b89c9	2025-10-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus 12 hour	PSEUDOEPHEDRINE HCL	L. Perrigo Company	26206f75-648f-47c9-8bad-25127c33961d	2025-10-03	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	2025-09-15	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Leader 12 Hour Sinus Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	a647e822-c4dd-46fd-bd55-bd9226990357	2025-08-07	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer Distribution Inc	4d431663-4b6a-4b00-9bbd-87d2c6b8ddad	2025-05-04	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b	2024-12-26	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	d600b5d5-7d95-4ad6-a95b-6d73502743d7	2024-11-08	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
good neighbor pharmacy nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Amerisource Bergen	d84a0c76-ad50-4616-9252-84ca25a19ca0	2024-05-30	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Equaline 12 Hour Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	bd5c2093-f812-4dfe-80ea-68cb4e65a09c	2023-08-03	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
Nasal Decongestant D	PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	9572b6c9-172b-459e-82d1-7f92f0eaec8e	2022-10-20	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
topcare 12 hour decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	4841c79a-fb92-4209-929a-e4ea0c4015dd	2022-10-05	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
sinus pressure and congestion relief maximum strength	PSEUDOEPHEDRINE HCL	Rite Aid Corporation	aa52d998-cab8-439c-ac95-6c1f5da48ba4	2022-08-04	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	85955336-3f79-457d-822c-f8be019729d1	2019-05-23	Warnings	Exact identifier application applno (ANDA): 075153 application number: ANDA075153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
70518-1618-0	70518161800	1 BLISTER PACK in 1 CARTON (70518-1618-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2018-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Pseudoephedrine Hydrochloride 120 mg Drug Facts	REMEDYREPACK INC.	2022-03-08	HUMAN OTC DRUG LABEL	6