FDA.reportPublic FDA data

health mart nasal decongestant pe

Product NDC
62011-0077
Requested package NDC
62011-0077-1
11-digit product format
620110077
Labeler code
62011
Product ID
62011-0077_ceebf78a-8761-4be8-8ea7-7a4a20f5a971
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-23
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage62011-007762011-0077-1DDiscontinued by firm2026-10-20

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0077-1EA - Each62011-0077f8267d51-76ec-438d-8bbd-15f62f3b152312012-07-24
62011-0077-2EA - Each62011-007706ba532a-2b89-4b8c-b334-a95ac2ef6f3712014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEALTH MART NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCKESSON]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0077-16201100770136 BLISTER PACK in 1 CARTON (62011-0077-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK36 blister pack2011-12-230000-00-00NoNoCurrent