Home NDC 55315-300-04 Childrens Plus Flu
Product NDC 55315-300
Requested package NDC 55315-300-04
11-digit product format 553150300
Labeler code 55315
Product ID 55315-300_922d7aae-33b4-4634-aef0-e89a34a3e6bf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI
Dosage form SUSPENSION
Route ORAL
Labeler Freds Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-30
Marketing end 2024-01-26
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 CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CHILDRENS PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI) SUSPENSION [FREDS INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55315-300-04 55315030004 1 BOTTLE, PLASTIC in 1 BOX (55315-300-04) > 118 mL in 1 BOTTLE, PLASTIC 2015-06-30 2024-01-26 No No Current