FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
59779-112
11-digit product format
597790112
Labeler code
59779
Product ID
59779-112_ac9e72aa-a381-4183-8b10-2794100b1a88
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
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
Brand name suffix
Non-Drowsy
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
3330b077-dab7-45c6-acbb-0f91f2271232Available 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
59779-112-08Nasal DecongestantNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED2421
59779-112-08Nasal DecongestantNon-Drowsy1 in 1 CARTONTABLET, FILM COATED121
59779-112-22Nasal DecongestantNon-Drowsy2 in 1 CARTONTABLET, FILM COATED221
59779-112-22Nasal DecongestantNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED2421
59779-112-46Nasal DecongestantNon-Drowsy4 in 1 CARTONTABLET, FILM COATED421
59779-112-46Nasal DecongestantNon-Drowsy24 in 1 BLISTER PACKTABLET, FILM COATED2421

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NNASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FNASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
TRIACETININACTIVE INGREDIENTXHX3C3X673NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-112NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]20Current NDC, Legacy NDC, 6 package rows20240711_3330b077-dab7-45c6-acbb-0f91f2271232.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 174 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
application number: M012
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
application number: M012
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab860c10-b8cf-3f92-e053-2a95a90a73172023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
application number: M012
Universal Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUSUniversal Distribution Center LLCb1d25572-da21-408d-aab3-3a0741dfff122023-11-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION09286d15-b63f-a9de-e063-6294a90ab9482023-11-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6cece6c-23e4-7811-e053-6394a90a106a2023-11-02WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049160pseudoephedrine HCl 30 MG Oral TabletPSN3330b077-dab7-45c6-acbb-0f91f227123221
1049160pseudoephedrine hydrochloride 30 MG Oral TabletSCD3330b077-dab7-45c6-acbb-0f91f227123221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-112-08597790112081 BLISTER PACK in 1 CARTON (59779-112-08) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1981-08-250000-00-00NoNoCurrent
59779-112-22597790112222 BLISTER PACK in 1 CARTON (59779-112-22) / 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1981-08-250000-00-00NoNoCurrent
59779-112-46597790112464 BLISTER PACK in 1 CARTON (59779-112-46) / 24 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1981-08-250000-00-00NoNoCurrent