FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
68016-473
Requested package NDC
68016-473-24
11-digit product format
680160473
Labeler code
68016
Product ID
68016-473_fc83b1ed-bf6b-4bf4-9bcc-365973e7d30d
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1981-08-25
Marketing end
2027-08-31
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Decongestant
Brand name suffix
Maximum Strength

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
270e9221-d305-4148-b523-741e02fe733fAvailable 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
68016-473-24Nasal DecongestantMaximum Strength1 in 1 CARTONTABLET, FILM COATED114
68016-473-24Nasal DecongestantMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2414
68016-473-96Nasal DecongestantMaximum Strength4 in 1 CARTONTABLET, FILM COATED414
68016-473-96Nasal DecongestantMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2414

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1
TRIACETININACTIVE INGREDIENTXHX3C3X673NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-473NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]13Current NDC, Legacy NDC, 4 package rows20250309_270e9221-d305-4148-b523-741e02fe733f.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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu plus Congestion NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALMART INC.1236b463-0073-44b5-a516-5b7c06a408872026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN270e9221-d305-4148-b523-741e02fe733f14
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD270e9221-d305-4148-b523-741e02fe733f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-473-24680160473241 BLISTER PACK in 1 CARTON (68016-473-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-252027-08-31NoNoCurrent