Home NDC 53441-311-06 Day Time Cold and Flu
Product NDC 53441-311
Requested package NDC 53441-311-06
11-digit product format 534410311
Labeler code 53441
Product ID 53441-311_bb3ee1ad-0da9-41b3-8385-bc0cf1b9d711
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler National Distribution Network (Smart Choice)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-06-30
Marketing end 2021-12-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/15mL; mg/15mL; mg/15mL
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53441-311-06 53441031106 177 mL in 1 BOTTLE (53441-311-06) 177 ml 2014-06-30 2021-12-30 No No Current