Healthy Accents Mucus Relief

Product NDC
55316-145
11-digit product format
553160145
Labeler code
55316
Product ID
55316-145_027df11b-9910-4e43-8174-7b461d40aa3f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DZA Brands LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-24
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; 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 productproduct55316-145DDiscontinued by firm2026-08-11
excluded packagepackage55316-14555316-145-39DDiscontinued by firm2026-08-11

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 packagepackage55316-145-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-145-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-145-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-145-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-145-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-145-39cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-145-39302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-145-39ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-145-390efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-145-39ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-145-39367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-145-39557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
GUAIFENESINACTIVE MOIETY495W7451VQHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEALTHY ACCENTS MUCUS RELIEF COLD AND SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [DZA BRANDS LLC]2