FDA.reportPublic FDA data

Nasal Decongestant

Product NDC
68210-4234
11-digit product format
682104234
Labeler code
68210
Product ID
68210-4234_edade565-841d-3f4f-e053-2995a90ac91c
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
2022-11-17
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4234IInactivated by FDA2026-08-10
excluded packagepackage68210-423468210-4234-6IInactivated by FDA2026-08-10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4234-6Nasal Decongestant60 in 1 POUCHTABLET, COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4234NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_30c7c95f-281f-4c65-b5ea-adc740b1238a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN30c7c95f-281f-4c65-b5ea-adc740b1238a4
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD30c7c95f-281f-4c65-b5ea-adc740b1238a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4234-66821042340660 TABLET, COATED in 1 POUCH (68210-4234-6) 2022-11-170000-00-00NoNoCurrent