Home NDC 76168-057 DAYTIME NIGHTTIME COLD/FLU
Product NDC 76168-057
11-digit product format 761680057
Labeler code 76168
Product ID 76168-057_f905bb92-063f-4b40-882d-f2e4514d8d8b
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Dosage form KIT
Route ORAL
Labeler Velocity Pharma
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-07-15
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76168-057-12 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76168-057-12 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76168-057-12 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76168-057-12 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76168-057-12 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76168-057-12 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76168-057-12 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76168-057-12 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76168-057-12 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76168-057-12 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 76168-057-12 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 76168-057-12 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 76168-057-12 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 76168-057-12 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 76168-057-12 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76168-057-12 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76168-057-12 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76168-057-12 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76168-057-12 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76168-057-12 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76168-057-12 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76168-057-12 DAYTIME NIGHTTIME COLD/FLU 1 in 1 CARTON KIT 1 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76168-057 DAYTIME NIGHTTIME COLD/FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [VELOCITY PHARMA] 2 Legacy NDC, 1 package rows 20140801_9c80c237-6316-4852-a437-480cf4a8997a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 76168-057-12 76168005712 1 in 1 CARTON Historical