Nasal Decongestant PE

Product NDC
37012-094
Requested package NDC
37012-094-23
11-digit product format
370120094
Labeler code
37012
Product ID
37012-094_bcf8f073-1068-48a0-9791-8e2a2a8786d5
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-02
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 packagepackage37012-09437012-094-23DDiscontinued by firm2026-10-16

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [SHOPKO STORES OPERATING CO., LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-094-233701200942312 BLISTER PACK in 1 CARTON (37012-094-23) > 6 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2013-10-030000-00-00NoNoCurrent