FDA.reportPublic FDA data

sinus and nasal decongestant

Product NDC
51316-616
11-digit product format
513160616
Labeler code
51316
Product ID
51316-616_00329fc8-144a-4254-8482-87adab8d9685
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA075153
Marketing category
ANDA
Marketing start
2026-01-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sinus and nasal decongestant
Listing expiration
2027-12-31

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
51316-616-52sinus and nasal decongestant10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE103
51316-616-52sinus and nasal decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
51316-616-60sinus and nasal decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13
51316-616-60sinus and nasal decongestant20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNe39daa3c-1901-4966-b85e-ab76d7bd12163
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDe39daa3c-1901-4966-b85e-ab76d7bd12163
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYe39daa3c-1901-4966-b85e-ab76d7bd12163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-616-525131606165210 BLISTER PACK in 1 CARTON (51316-616-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2026-01-20NoNoCurrent
51316-616-605131606166020 BLISTER PACK in 1 CARTON (51316-616-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2026-01-28NoNoCurrent