FDA.reportPublic FDA data

nasal decongestant pe

Product NDC
56062-094
Requested package NDC
56062-094-23
11-digit product format
560620094
Labeler code
56062
Product ID
56062-094_4f870e02-92ed-4df9-84d8-718e199960ad
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Publix Super Markets Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-06-10
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 packagepackage56062-09456062-094-23DDiscontinued by firm2026-10-12

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 · 10 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…

Reported adverse events (FAERS/openFDA)#

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

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-094-23EA - Each56062-09481a0d503-e632-4a66-a4cc-32b9a4b4c3f912012-07-24
56062-094-89EA - Each56062-094dc2d2f30-93e4-4ed3-9d45-de6528ddfabb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-094-23560620094233 BLISTER PACK in 1 CARTON (56062-094-23) > 24 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2005-06-100000-00-00NoNoCurrent