FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
59779-432
11-digit product format
597790432
Labeler code
59779
Product ID
59779-432_ef714af1-6ebb-4909-9f55-6e42547480e3
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1987-07-15
Marketing end
2027-04-30
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

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

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
59779-432-62Nasal Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED16
59779-432-62Nasal Decongestant24 in 1 CARTONTABLET, FILM COATED246
59779-432-67Nasal Decongestant48 in 1 CARTONTABLET, FILM COATED486
59779-432-67Nasal Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED16
59779-432-80Nasal Decongestant96 in 1 CARTONTABLET, FILM COATED966
59779-432-80Nasal Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-432-62EA - Each59779-432c47ee4f1-4400-4ce4-82ce-13dcd3089f7d12016-09-02
59779-432-67EA - Each59779-4329b76a668-2b19-48e9-a73e-82935ff0f98212016-09-02
59779-432-80EA - Each59779-4321367b0f0-23ec-4ac4-aacc-6204c4840a7612016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-432NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]6Current NDC, Legacy NDC, 6 package rows20240922_bebe5e78-09ba-4d35-9d34-9f5e34341478.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 48 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kids Daytime Cough and Nighttime Cough combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEGenexa Inc.4bad39f1-86d4-b8a1-e063-6394a90a7a952026-02-25WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals67072a38-1ae7-4e59-bfed-71db0d93215d2026-02-25WarningsExact identifier
application number: M012
leader tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderb3e3699b-b36c-453c-8f3b-0001388c8e822026-02-25WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
VaproizingCAMPHORH E B577fda09-588a-4c2e-ada5-eeda32d1aabe2026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
application number: M012
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
application number: M012
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
application number: M012
Cough DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED39adf23e-76f3-42e1-a9f4-55feb38078e52026-02-24WarningsExact identifier
application number: M012
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands47317865-4310-4f07-8815-f3130963307d2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Brands42720fa0-fcdd-4614-80b2-16d0ada345b12026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brandscc09a8c5-d173-4261-b838-96e6a16e2ff92026-02-23WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands96a1055f-e831-4f4b-8af3-7a41838c194c2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Brands1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2462026-02-23WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBetter Living Brands, LLC0948648c-1c5f-4225-a754-120ca8859f192026-02-23Warnings, Adverse reactionsExact identifier
application number: M012
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
application number: M012
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSNbebe5e78-09ba-4d35-9d34-9f5e343414786
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCDbebe5e78-09ba-4d35-9d34-9f5e343414786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-432-625977904326224 BLISTER PACK in 1 CARTON (59779-432-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack1987-07-152027-04-30NoNoCurrent
59779-432-675977904326748 BLISTER PACK in 1 CARTON (59779-432-67) / 1 TABLET, FILM COATED in 1 BLISTER PACK48 blister pack1997-08-292026-11-30NoNoCurrent
59779-432-805977904328096 BLISTER PACK in 1 CARTON (59779-432-80) / 1 TABLET, FILM COATED in 1 BLISTER PACK96 blister pack1997-07-282027-04-30NoNoCurrent