Flu Relief

Product NDC
36800-000
11-digit product format
368000000
Labeler code
36800
Product ID
36800-000_b751bc31-7da8-4a33-9617-11cb4ecb1035
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI
Dosage form
SUSPENSION
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-31
Marketing end
2021-12-30
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
0000-00-00
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 productproduct36800-000DDiscontinued by firm2026-10-16
excluded packagepackage36800-00036800-000-04DDiscontinued by firm2026-10-16

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 packagepackage36800-000-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-000-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-000-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-000-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-000-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-000-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-000-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-000-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-000-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-000-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-000-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-000-04557ba5c1ecfa…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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
SORBITOLINACTIVE INGREDIENT506T60A25RFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
SUCROSEINACTIVE INGREDIENTC151H8M554FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
WATERINACTIVE INGREDIENT059QF0KO0RFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-000-04368000000041 BOTTLE, PLASTIC in 1 BOX (36800-000-04) > 118 mL in 1 BOTTLE, PLASTIC2015-07-312021-12-30NoNoCurrent