Nasal Decongestant

Product NDC: 50844-112
11-digit product format: 508440112
Labeler code: 50844
Product ID: 50844-112_962e4e53-1137-48a6-888c-05bb0b5e648b
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: L.N.K. International, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-08-25
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 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

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: Nasal Decongestant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 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
1049160	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
f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50844-112-08	Nasal Decongestant	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	19
50844-112-08	Nasal Decongestant	2 in 1 CARTON	TABLET, FILM COATED	2	19
50844-112-22	Nasal Decongestant	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	19
50844-112-22	Nasal Decongestant	4 in 1 CARTON	TABLET, FILM COATED	4	19
50844-112-46	Nasal Decongestant	8 in 1 CARTON	TABLET, FILM COATED	8	19
50844-112-46	Nasal Decongestant	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50844-112-22	EA - Each	50844-112	3310c6ff-4340-4e26-8aa0-c254b60bed98	1	2022-06-06
50844-112-46	EA - Each	50844-112	9d0541ce-08ce-4cb0-8680-608ec5e8ee89	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50844-112	NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	17	Current NDC, Legacy NDC, 6 package rows	20240816_f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Panadol Cold and Flu Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3417993d-8e3c-23d6-e063-6394a90a7d50	2026-04-29	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	509f233e-ff01-8927-e063-6394a90a9929	2026-04-29	Warnings	Exact identifier application number: M012
Broncomiel Adults	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509c61d3-ae16-be5c-e063-6294a90a68da	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	TOP CARE (Topco Associates LLC)	aa1eb90c-e565-455f-8978-6f2f9e00a814	2026-04-29	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	e1280355-da81-489f-9bd2-ffea9a68010c	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	7b095ec5-9951-4491-9b68-7ac0a7f10053	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOP CARE (Topco Associates LLC)	98dd0ba6-0109-46b2-92df-11a030984240	2026-04-28	Warnings	Exact identifier application number: M012
Pain, Headache and Congestion	ACETAMINOPHEN, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	41a77cbb-6a4d-46a4-ab27-c7affa2cc682	2026-04-28	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	dd7da15a-4e0b-405f-e053-2995a90a06d2	2026-04-28	Warnings	Exact identifier application number: M012
CAREONE CHILDRENS COLD COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Retail Business Services, LLC	382f7d51-ceb8-4bdf-9bd5-440b50c65cd3	2026-04-28	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	1a520b4f-6a4b-4e37-94c5-9387f2e4c34a	2026-04-27	Warnings	Exact identifier application number: M012
Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kroger	49a7cd2a-8c0e-2196-e063-6294a90a134a	2026-04-27	Warnings	Exact identifier application number: M012
Guaifenesin,Dextromethorphan Hbr	GUAIFENESIN,DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	3e5d978f-cc70-60a5-e063-6394a90a67d3	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	36ced59c-12dc-441f-e063-6294a90a3239	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Softgel Healthcare Private Limited	30ab39f3-27cc-5728-e063-6394a90a9cbe	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	353f71f7-81e0-08c2-e063-6294a90acb49	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	Softgel Healthcare Pvt Ltd	353ef34f-760d-ae92-e063-6294a90a5b4a	2026-04-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	507214ad-1e06-fe21-e063-6294a90a59cd	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50738a43-7299-270c-e063-6294a90af2cc	2026-04-27	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
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5	19
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50844-112-08	50844011208	2 BLISTER PACK in 1 CARTON (50844-112-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1981-08-25	0000-00-00	No	No	Current
50844-112-22	50844011222	4 BLISTER PACK in 1 CARTON (50844-112-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	1981-08-25	0000-00-00	No	No	Current
50844-112-46	50844011246	8 BLISTER PACK in 1 CARTON (50844-112-46) / 12 TABLET, FILM COATED in 1 BLISTER PACK	8 blister pack	1981-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Plus 44-112	L.N.K. International, Inc. \| LNK International, Inc.	2025-09-15	HUMAN OTC DRUG LABEL	19