FDA.reportPublic FDA data

nasal decongestant pe

Product NDC
59779-094
Requested package NDC
59779-094-68
11-digit product format
597790094
Labeler code
59779
Product ID
59779-094_bc971f12-925d-400b-921e-bd8fdf58197e
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-02-17
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage59779-09459779-094-68DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-094-68EA - Each59779-09473704be5-8d75-4fae-b8e2-ebf48a487b0f12022-06-06
59779-094-89EA - Each59779-094a4f97761-28e7-42f7-9f11-8cf1b68c7df812020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [CVS PHARMACY]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-094-68597790094686 BLISTER PACK in 1 CARTON (59779-094-68) > 6 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2006-10-030000-00-00NoNoCurrent