FDA.reportPublic FDA data

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
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 5 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact 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