FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
50844-112
11-digit product format
508440112
Labeler code
50844
Product ID
50844-112_478a22dd-e80a-44c4-abb3-ec361d945afd
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
2027-12-31
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
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049160Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-112-08Nasal Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-112-08Nasal Decongestant2 in 1 CARTONTABLET, FILM COATED219
50844-112-22Nasal Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED1219
50844-112-22Nasal Decongestant4 in 1 CARTONTABLET, FILM COATED419
50844-112-46Nasal Decongestant8 in 1 CARTONTABLET, FILM COATED819
50844-112-46Nasal Decongestant12 in 1 BLISTER PACKTABLET, FILM COATED1219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50844-112-22EA - Each50844-1123310c6ff-4340-4e26-8aa0-c254b60bed9812022-06-06
50844-112-46EA - Each50844-1129d0541ce-08ce-4cb0-8680-608ec5e8ee8912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-112NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]17Current NDC, Legacy NDC, 6 package rows20240816_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 70 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC29f3f6dd-751e-1dfe-e063-6394a90a0dbb2025-12-22WarningsExact identifier
application number: M012
MGC Cough DropsMENTHOLMedical Group Care LLC437f6b77-ecf8-2cd8-e063-6394a90ad45d2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYMedical Group Care LLCf4a92a69-e562-1cec-e053-2a95a90a01652025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYMedical Group Care LLC043999bc-3efe-5d29-e063-6294a90a95f42025-12-22WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryPECTIN, MENTHOLChain Drug Marketing Association, Inc.18d28b91-55a7-4d0d-8404-4f21afdef9892025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART0668492e-c47e-b7cf-e063-6394a90a309b2025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART06574e56-13b8-a3af-e063-6394a90a48672025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART0668ddcc-0214-8e97-e063-6294a90a4f322025-12-22WarningsExact identifier
application number: M012
caring mill Cough drops CHERRYMENTHOLFSA STORE INC.9d666061-f7a8-4318-8db1-b65373689e1d2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS CHERRYPharmacy Value Alliance LLC018f4790-8785-94f4-e063-6394a90a19162025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONPharmacy Value Alliance LLC0191fcf7-abc1-e583-e063-6294a90a78542025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEPharmacy Value Alliance LLC018f20b1-06e0-eb13-e063-6394a90a5ec52025-12-22WarningsExact identifier
application number: M012
Quality Choice Cherry Cough DropsCHERRY COUGH DROPSChain Drug Marketing Association, Inc.6a407092-4b71-4156-b4ad-930782b5fb432025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Cough DropsHONEY LEMON COUGH DROPSChain Drug Marketing Association, Inc.1fd09b04-9c79-da20-e063-6394a90ae2632025-12-22WarningsExact identifier
application number: M012
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNf12b7f07-0b81-4cab-ae0f-43a7bf9b4bc519
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDf12b7f07-0b81-4cab-ae0f-43a7bf9b4bc519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-112-08508440112082 BLISTER PACK in 1 CARTON (50844-112-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1981-08-250000-00-00NoNoCurrent
50844-112-22508440112224 BLISTER PACK in 1 CARTON (50844-112-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1981-08-250000-00-00NoNoCurrent
50844-112-46508440112468 BLISTER PACK in 1 CARTON (50844-112-46) / 12 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack1981-08-250000-00-00NoNoCurrent