FDA.reportPublic FDA data

pseudoephedrine hydrochloride

Product NDC
45802-432
11-digit product format
458020432
Labeler code
45802
Product ID
45802-432_c25dd71c-bfa6-45c6-a4f0-a46919acf185
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-10-17
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
pseudoephedrine hydrochloride
Listing expiration
2027-12-31

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
458594e1-8d99-4de3-8923-2fd8ce2fc406Available 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
45802-432-62pseudoephedrine hydrochloride24 in 1 CARTONTABLET, FILM COATED247
45802-432-62pseudoephedrine hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-432-62EA - Each45802-43248979347-5d83-499a-ab2a-ed912a75442812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-432PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20240822_458594e1-8d99-4de3-8923-2fd8ce2fc406.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 141 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC50528d29-ce8c-4efb-a86c-17246b017db02024-11-07WarningsExact identifier
application number: M012
cooling severe daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacyd4a21760-b2bd-4e26-bff0-6fc1b05d26b32024-11-07WarningsExact identifier
application number: M012
dg health day time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLC60870311-3234-44ba-95dd-09cf4ea3d5082024-11-07WarningsExact identifier
application number: M012
adult dm max cough and chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution Inc3a6855c1-da6d-4fa9-81fe-d2e61355989f2024-11-06WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionse51dfb62-40d0-4bec-9574-90057cb35bcc2024-11-06WarningsExact identifier
application number: M012
Foster and Thrive Adult Tussin DM MAXDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Services LLC5f6e4d56-4a66-4dbd-97c8-550310dea3582024-11-05WarningsExact identifier
application number: M012
Cough Drops Honey Lemon with SugarMENTHOLLidl US LLC4ad9398f-7488-6eaf-e054-00144ff8d46c2024-11-05WarningsExact identifier
application number: M012
rexall dm cough and congestion reliefDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLC906838b1-a742-4728-944d-42b687b8cd592024-11-05WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINH E B7c24c59c-7549-4c64-95f8-4bf755cd6f612024-11-05WarningsExact identifier
application number: M012
equate adult tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inc3592e000-a6c6-47fe-8bb0-9341c65c29592024-11-05WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company756794b0-8d3b-4732-947c-a407caf400e22024-11-05WarningsExact identifier
application number: M012
basic care tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCc6863e31-e1b9-40ff-ae2e-4aec86b4acc02024-11-05WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a2024-11-05WarningsExact identifier
application number: M012
Childrens Sudafed PE NASAL DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d2024-11-04WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.164b2559-2d3f-431e-a03c-07e86731af5c2024-11-04WarningsExact identifier
application number: M012
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN204849d1-ac4b-4dbe-8769-fcb30291f88010
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD204849d1-ac4b-4dbe-8769-fcb30291f88010
1049160pseudoephedrine HCl 30 MG Oral TabletPSN458594e1-8d99-4de3-8923-2fd8ce2fc4067
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD458594e1-8d99-4de3-8923-2fd8ce2fc4067
1049160pseudoephedrine HCl 30 MG Oral TabletPSNa910320b-0585-40bd-928c-0406346281d03
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDa910320b-0585-40bd-928c-0406346281d03
1049160pseudoephedrine HCl 30 MG Oral TabletPSN909dacfa-50d3-4bcf-b2df-5405427cfaad2
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD909dacfa-50d3-4bcf-b2df-5405427cfaad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-432-624580204326224 BLISTER PACK in 1 CARTON (45802-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2008-10-170000-00-00NoNoCurrent