Pseudoephedrine Hydrochloride

Product NDC: 50090-4546
11-digit product format: 500904546
Labeler code: 50090
Product ID: 50090-4546_0510b7be-7889-42a1-8992-f47faefd2bd3
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-26
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	50090-4546	50090-4546-0	D	Discontinued by firm	2026-10-20
excluded package	package	50090-4546	50090-4546-3	D	Discontinued by firm	2026-10-20
excluded package	package	50090-4546	50090-4546-4	D	Discontinued by firm	2026-10-20
excluded package	package	50090-4546	50090-4546-5	D	Discontinued by firm	2026-10-20

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 · 8 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	50090-4546-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50090-4546-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50090-4546-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50090-4546-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	50090-4546-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50090-4546-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50090-4546-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50090-4546-5	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: Pseudoephedrine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049167	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
810ce630-41be-4e15-b64a-d70f63abaf62	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4546-0	2023-02-07	1215-Major
50090-4546-1	2023-02-07	1215-Major
50090-4546-3	2023-02-07	1215-Major
50090-4546-4	2023-02-07	1215-Major
50090-4546-5	2023-02-07	1215-Major
50090-4546-0	2023-01-30	1215-Major
50090-4546-1	2023-01-30	1215-Major
50090-4546-3	2023-01-30	1215-Major
50090-4546-4	2023-01-30	1215-Major
50090-4546-5	2023-01-30	1215-Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-4546-0	Pseudoephedrine Hydrochloride	24 in 1 BOTTLE	TABLET	24	17
50090-4546-1	Pseudoephedrine Hydrochloride	30 in 1 BOTTLE	TABLET	30	17
50090-4546-3	Pseudoephedrine Hydrochloride	12 in 1 BOTTLE	TABLET	12	17
50090-4546-4	Pseudoephedrine Hydrochloride	20 in 1 BOTTLE	TABLET	20	17
50090-4546-5	Pseudoephedrine Hydrochloride	15 in 1 BOTTLE	TABLET	15	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4546-1	EA - Each	50090-4546	103bdf42-6855-49a0-9cff-e992b024c975	1	2022-07-06
50090-4546-3	EA - Each	50090-4546	42cccd03-ae3d-44ad-b461-dfea29a316e2	1	2021-05-05
50090-4546-4	EA - Each	50090-4546	75464fe6-9da2-4ee1-b365-1ad34e24d650	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4546	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	17	Current NDC, Legacy NDC, 5 package rows	20250426_810ce630-41be-4e15-b64a-d70f63abaf62.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 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	14c56f3d-67fd-45ef-a16b-f27604722883	2026-05-12	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	51a4195b-8776-964c-e063-6294a90aa075	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba3548e-85e7-b4a6-e063-6394a90af84d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe7eeb71-e219-4c84-ac06-98c3a40b14dc	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6f8241d7-0f30-40b3-926b-861c57079f1d	2026-05-12	Warnings	Exact identifier application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51a45db8-2bee-6fd0-e063-6394a90ab587	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	19da539e-7b57-41d7-aad5-fc89a6705e20	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	182222b5-a852-4dbe-b05f-a41d89806021	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8a790eeb-7d7d-4a94-9103-6ed09c04d596	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	dbdafbb4-f3c9-4042-b867-db4d06dc3d61	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	29571047-4c4b-44ca-8726-57c28308e8cf	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	75c6b92f-219f-4740-bb72-c02a927a21ff	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	c746953f-4b7d-4e2a-9b85-96bd6901f517	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	cea08797-1d53-4434-be1a-144f2ded5f9d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ef9d5de-e99e-4398-bf97-c7bef94498fa	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a401eb92-60b6-427d-a677-29371a3150be	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ff4c4ea-7628-4d2b-a6e9-d994c25baef4	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7c18e95-8d7b-4550-9a20-fc704a114adb	2026-05-12	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049167	pseudoephedrine HCl 60 MG Oral Tablet	PSN	810ce630-41be-4e15-b64a-d70f63abaf62	17
1049167	pseudoephedrine hydrochloride 60 MG Oral Tablet	SCD	810ce630-41be-4e15-b64a-d70f63abaf62	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4546-0	50090454600	24 TABLET in 1 BOTTLE (50090-4546-0)	24 tablet	2019-09-20	0000-00-00	No	No	Current
50090-4546-1	50090454601	30 TABLET in 1 BOTTLE (50090-4546-1)	30 tablet	2019-09-20	0000-00-00	No	No	Current
50090-4546-3	50090454603	12 TABLET in 1 BOTTLE (50090-4546-3)	12 tablet	2019-09-27	0000-00-00	No	No	Current
50090-4546-4	50090454604	20 TABLET in 1 BOTTLE (50090-4546-4)	20 tablet	2019-09-20	0000-00-00	No	No	Current
50090-4546-5	50090454605	15 TABLET in 1 BOTTLE (50090-4546-5)	15 tablet	2019-09-20	0000-00-00	No	No	Current