Home NDC 41520-491-48 DayTime Nitetime cold and flu relief
Product NDC 41520-491
Requested package NDC 41520-491-48
11-digit product format 415200491
Labeler code 41520
Product ID 41520-491_985662a0-7a67-4031-8538-3f7d9d4f4dae
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form KIT
Labeler Care One (American Sales Company)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-08-14
Marketing end 2022-04-01
Active strength 0
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 DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CARE ONE (AMERICAN SALES COMPANY)] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41520-491-48 41520049148 1 KIT in 1 CARTON (41520-491-48) * 8 CAPSULE in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK 1 kit 2012-08-14 2022-04-01 No No Current