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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Rite Aid Corporation	f1a4ee57-33a3-4791-a769-b208b38acb72	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	c499574c-f32b-4608-bf8b-51ad44e35725	2026-07-13	Warnings	Exact identifier application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	f442c61b-7d2c-401c-b862-acbe2282927b	2026-07-13	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	404a3521-8340-4476-a068-0e69cd0e514f	2026-07-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Long Acting Cough Adult Tussin	DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	df3c76bd-bd5b-42d7-a5f1-560fd3cba646	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	a217ca8a-1c00-4816-bc26-cc0f71c80c90	2026-07-13	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	1ddc04fb-069c-44fe-814b-ba4f503c4be0	2026-07-10	Warnings	Exact identifier application number: M012
COUGH DROPS- menthol granule	MENTHOL GRANULE	Anhui Jiuhe Health Industry Co., Ltd	5351b943-5830-e4e7-e063-6394a90a5b66	2026-07-10	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant PE Phenylephrine	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	3f284420-87c1-4c17-99e5-bc569bf9d45f	2026-07-10	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Multi-Symptom Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	707eb066-cdfc-444b-833a-9d6d133d48e4	2026-07-10	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