69790-161 NDC - ULINE SINUS AND CONGESTION (PHENYLEPHRINE HYDROCHLORIDE)

Drug Information

  • Product NDC: 69790-161
  • Proprietary Name: Uline Sinus and Congestion
  • Non Proprietary Name: phenylephrine hydrochloride
  • Active Ingredient(s): 5 mg/1 PHENYLEPHRINE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Adrenergic alpha1-Agonists [MoA]; alpha-1 Adrenergic Agonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Uline
Product Type: HUMAN OTC DRUG
FDA Application Number: M012
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:10/7/2019

Package Information

No. Package Code Package Description Billing Unit
169790-161-3350 PACKET in 1 BOX (69790-161-33) / 2 TABLET, FILM COATED in 1 PACKET

NDC Record

Field Name Field Value Definition
PRODUCT NDC69790-161The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEUline Sinus and CongestionThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEphenylephrine hydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/7/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGThis is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBERM012This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEUlineName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPHENYLEPHRINE HYDROCHLORIDEName of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH5 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] 

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This page was last updated on: 12/6/2025