Healthy Accents infants pain and fever

Product NDC
55316-161
11-digit product format
553160161
Labeler code
55316
Product ID
55316-161_611f32e1-6e7e-4d77-89c9-1c2c4a5cb295
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
DZA Brands LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-06
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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 productproduct55316-161DDiscontinued by firm2026-08-11
excluded packagepackage55316-16155316-161-16DDiscontinued 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 packagepackage55316-161-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-161-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-161-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-161-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-161-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-161-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-161-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-161-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-161-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-161-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-161-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-161-16557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8HEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505HEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
SORBITOLINACTIVE INGREDIENT506T60A25RHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RHEALTHY ACCENTS INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [DZA BRANDS LLC]3