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

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 Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049160

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

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