Nasal Decongestant

Product NDC
68210-4224
Requested package NDC
68210-4224-6
11-digit product format
682104224
Labeler code
68210
Product ID
68210-4224_ed853c61-ca79-4c3d-e053-2995a90aecb9
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-15
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-422468210-4224-6IInactivated by FDA2026-10-30

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4224-6Nasal Decongestant60 in 1 JARTABLET, COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4224NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_e8d038a3-ce56-46b8-a163-3339bd509ee8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNe8d038a3-ce56-46b8-a163-3339bd509ee84
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDe8d038a3-ce56-46b8-a163-3339bd509ee84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4224-66821042240660 TABLET, COATED in 1 JAR (68210-4224-6) 2022-11-150000-00-00NoNoCurrent