Home NDC 68599-1631 McKesson Phenylephrine HCl
Product NDC 68599-1631
11-digit product format 685991631
Labeler code 68599
Product ID 68599-1631_266bbe87-c019-f406-e063-6394a90a516c
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler McKesson Medical-Surgical
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-01
Marketing end 2027-08-31
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
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 McKesson Phenylephrine HCl Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1299145 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68599-1631-3 McKesson Phenylephrine HCl 250 in 1 BOX TABLET, FILM COATED 250 3 68599-1631-3 McKesson Phenylephrine HCl 2 in 1 PACKET TABLET, FILM COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68599-1631 MCKESSON PHENYLEPHRINE HCL (PHENYLEPHRINE HCL) TABLET, FILM COATED [MCKESSON MEDICAL-SURGICAL] 3 Current NDC, Legacy NDC, 2 package rows 20241109_e09060f7-ca0b-5f7c-e053-2995a90ab344.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 98 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68599-1631-3 68599163103 250 PACKET in 1 BOX (68599-1631-3) / 2 TABLET, FILM COATED in 1 PACKET 250 packet 2022-09-01 2027-08-31 No No Current