Home NDC 36800-000-04 Flu Relief
Product NDC 36800-000
Requested package NDC 36800-000-04
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLU RELIEF CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE FLU 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 NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-000-04 36800000004 1 BOTTLE, PLASTIC in 1 BOX (36800-000-04) > 118 mL in 1 BOTTLE, PLASTIC 2015-07-31 2021-12-30 No No Current