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	2026-10-21
excluded package	package	50090-4546	50090-4546-3	D	Discontinued by firm	2026-10-21
excluded package	package	50090-4546	50090-4546-4	D	Discontinued by firm	2026-10-21
excluded package	package	50090-4546	50090-4546-5	D	Discontinued by firm	2026-10-21

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 48 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Daytime Cough and Nighttime Cough combo pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Genexa Inc.	4bad39f1-86d4-b8a1-e063-6394a90a7a95	2026-02-25	Warnings	Exact identifier application number: M012
dimaphen dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	67072a38-1ae7-4e59-bfed-71db0d93215d	2026-02-25	Warnings	Exact identifier application number: M012
leader tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	b3e3699b-b36c-453c-8f3b-0001388c8e82	2026-02-25	Warnings	Exact identifier application number: M012
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	97554f40-f9aa-4dbf-a6f2-de6197236ab4	2026-02-25	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Family Dollar Stores, Inc	1b50b865-3dfc-4b3f-86d5-5e91ca772445	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Vaproizing	CAMPHOR	H E B	577fda09-588a-4c2e-ada5-eeda32d1aabe	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	Major Pharmaceuticals	11416620-4892-44ba-9780-db27efff6743	2026-02-24	Warnings	Exact identifier application number: M012
Family Wellness SF Honey Lemon Cough Drops	MENTHOL	Family Dollar	4437853d-1f42-a41d-e063-6294a90aa81e	2026-02-24	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	64a93715-e7b1-4de1-8099-8ad6c585d517	2026-02-24	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	86af74c2-9183-4ee9-ad1e-d88dfc8bf47d	2026-02-24	Warnings	Exact identifier application number: M012
Cough DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	39adf23e-76f3-42e1-a9f4-55feb38078e5	2026-02-24	Warnings	Exact identifier application number: M012
Revasol Tussin DM Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rnv LLC	4b7fd320-2f39-fa1a-e063-6294a90ada9e	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	47317865-4310-4f07-8815-f3130963307d	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Brands	42720fa0-fcdd-4614-80b2-16d0ada345b1	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	cc09a8c5-d173-4261-b838-96e6a16e2ff9	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	96a1055f-e831-4f4b-8af3-7a41838c194c	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Brands	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	2026-02-23	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Better Living Brands, LLC	0948648c-1c5f-4225-a754-120ca8859f19	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Exact identifier application number: M012
Equate Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	3006971b-784c-43fd-91a6-d96876bbf185	2026-02-23	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