Healthy Accents Nasal Decongestant

Product NDC
55316-432
11-digit product format
553160432
Labeler code
55316
Product ID
55316-432_02b67767-be98-4f91-8db7-fcf164df13a3
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DZA Brands LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-23
Marketing end
0000-00-00
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55316-432DDiscontinued by firm2026-10-05
excluded packagepackage55316-43255316-432-67DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-432-67d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-432-67f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-432-672ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-432-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-432-67cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-432-67cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-432-67302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-432-67ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-432-670efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-432-67ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-432-67367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-432-67557ba5c1ecfa…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
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEALTHY ACCENTS NASAL DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [DZA BRANDS LLC]1