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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold Cough and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	a35531d7-1a96-45cb-922f-61db085cde1f	2026-06-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	5fe9f313-d6e7-41f5-abfc-e4c72b708961	2026-06-15	Warnings	Exact identifier application number: M012
Pain Relief Sinus Congestion	ACETAMINOPHEN, PHENYLEPHRINE HCL	Better Living Brands, LLC	1d3d6397-0d92-4145-9a70-8bcc45bd0322	2026-06-15	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d5d9334d-3db6-4f45-ab84-3e1ec5a752c6	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Geiss, Destin & Dunn Inc.	fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b	2026-06-15	Warnings	Exact identifier application number: M012
equate daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	983a4783-d826-41b6-8087-ca66bcd5b6ca	2026-06-12	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	4173ecde-a2d7-4836-a6e9-fef2270d1b4e	2026-06-12	Warnings	Exact identifier application number: M012
PAIN RELIEVER PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	cf370a59-42d5-42fe-882f-09885c55f570	2026-06-11	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion Plus Cold Severe Day	ACETAMINOPHEN, PSEUDOEPHEDRINE	Kenvue Brands LLC	537e1a0d-820d-c3f7-e063-6294a90a56ea	2026-06-10	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and Night	ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE	Kenvue Brands LLC	5382dcad-0337-4440-e063-6394a90a706e	2026-06-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	21cfa71c-7a8f-4100-a42e-9190260653d1	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	WALGREENS	47f1d92f-cb4b-1635-e063-6294a90a2c71	2026-06-09	Warnings	Exact identifier application number: M012
HALLS Honey	MENTHOL	Mondelez Global LLC	837f5ded-8efb-402b-a1bc-b5c142755660	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	932b11b1-f4a0-417a-bfa1-05261a172155	2026-06-08	Warnings	Exact identifier application number: M012
NO DRIP NASAL MIST	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	957efbcf-b6d3-4793-bb6e-27e99c9be905	2026-06-08	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	493caecb-e687-49ea-b7a1-2a5b9376896d	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	4ad10fd7-c088-4356-9d34-a95cfe3a4133	2026-06-08	Warnings	Exact identifier application number: M012
Theraflu Severe Congestion Relief Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	4ec42064-7390-4137-a93e-57343c3c76a7	2026-06-08	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