Home NDC 55629-016-01 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate
Product NDC 55629-016
Requested package NDC 55629-016-01
11-digit product format 556290016
Labeler code 55629
Product ID 55629-016_565b9a99-fa8f-47de-bf6a-6496657b56d4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler ONE2ZEE LIMITED LIABILITY COMPANY
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-03-02
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE
Active strength 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 55629-016-01 2025-01-30 C162847 48780-1 f386c64a-422f-0266-e053-dadaa90a7c1a Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg) 55629-016-01 2023-03-25 C162847 48780-1 f386c64a-422f-0266-e053-dadaa90a7c1a Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg) 55629-016-01 2023-01-30 C162847 48780-1 f386c64a-422f-0266-e053-dadaa90a7c1a Nighttime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, Doxylamine Succinate 6.25 mg)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55629-016-01 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate 48 in 1 CARTON CAPSULE, LIQUID FILLED 48 2 55629-016-02 Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate 300 in 1 POUCH CAPSULE, LIQUID FILLED 300 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55629-016 ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY] 2 Legacy NDC, 2 package rows 20230326_bc11b349-9e1c-4e3c-80d2-07749a67391e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55629-016-01 55629001601 48 POUCH in 1 CARTON (55629-016-01) > 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-016-02) 48 pouch 2021-03-02 0000-00-00 No No Current