healthy accents childrens multi symptom fever and cold

Product NDC
55316-005
11-digit product format
553160005
Labeler code
55316
Product ID
55316-005_792cc0b4-7d66-4563-a9e3-cbd15cea6935
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
DZA Brands LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
160 mg/5mL; mg/5mL; mg/5mL; 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 productproduct55316-005DDiscontinued by firm2026-08-11
excluded packagepackage55316-00555316-005-26DDiscontinued 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 packagepackage55316-005-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-005-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-005-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-005-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-005-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-005-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-005-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-005-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-005-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-005-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55316-005-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55316-005-26557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505HEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554HEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHEALTH MART MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [DZA BRANDS LLC]1