12 Hour Nasal Decongestant

Product NDC
59779-703
11-digit product format
597790703
Labeler code
59779
Product ID
59779-703_dcfaf9dd-eada-4fd1-84f0-ef0bc2dc5029
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075153
Marketing category
ANDA
Marketing start
1999-12-01
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 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
12 Hour Nasal Decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

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
59779-703-5212 Hour Nasal Decongestant10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE106
59779-703-5212 Hour Nasal Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE16
59779-703-6012 Hour Nasal Decongestant20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE206
59779-703-6012 Hour Nasal Decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-703-52EA - Each59779-703b3049d84-1248-43e1-a6b8-299d2142ca1612017-03-06
59779-703-60EA - Each59779-703d1745b90-d7df-45c7-95c0-70c97c9fe15312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I3012 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU412 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP12 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-70312 HOUR NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]6Current NDC, Legacy NDC, 4 package rows20190524_85955336-3f79-457d-822c-f8be019729d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN85955336-3f79-457d-822c-f8be019729d16
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD85955336-3f79-457d-822c-f8be019729d16
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY85955336-3f79-457d-822c-f8be019729d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-703-525977907035210 BLISTER PACK in 1 CARTON (59779-703-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack1999-12-010000-00-00NoNoCurrent
59779-703-605977907036020 BLISTER PACK in 1 CARTON (59779-703-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2000-09-110000-00-00NoNoCurrent