healthy accents cold and allergy

Product NDC
55316-906
11-digit product format
553160906
Labeler code
55316
Product ID
55316-906_9303b976-f42e-445b-8c27-39e894e04089
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hcl, brompheniramine maleate
Dosage form
LIQUID
Route
ORAL
Labeler
DZA Brands LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-04-01
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
Active strength
5 mg/10mL; mg/10mL
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 productproduct55316-906DDiscontinued by firm2026-10-05
excluded packagepackage55316-90655316-906-26DDiscontinued 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 packagepackage55316-906-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-906-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-906-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-906-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-906-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-906-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-906-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-906-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-906-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-906-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-906-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-906-26557ba5c1ecfa…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
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03HEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHEALTHY ACCENTS COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [DZA BRANDS LLC]1