Home NDC 41250-763 Nitetime Cold and Flu
Product NDC 41250-763
11-digit product format 412500763
Labeler code 41250
Product ID 41250-763_da99aac2-179f-499c-80a8-88dc141c3e46
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form SOLUTION
Route ORAL
Labeler Meijer Distribution Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-12-11
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Nitetime Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1431245 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-763-40 Nitetime Cold and Flu 355 mL in 1 BOTTLE SOLUTION 355 8 41250-763-50 Nitetime Cold and Flu 2 in 1 PACKAGE SOLUTION 2 8 41250-763-50 Nitetime Cold and Flu 355 mL in 1 BOTTLE SOLUTION 355 8 41250-763-40 NiteTime DayTimeCold and Flu 355 mL in 1 BOTTLE SOLUTION 355 mL 650 mg in 30mL 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 3 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-763 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [MEIJER DISTRIBUTION INC] 7 Current NDC, Legacy NDC, 3 package rows 20241016_47f03174-6e91-4529-bbfa-ce58aa7b7d79.zip 41250-763 NITETIME DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION INC] 6 Current NDC, Legacy NDC 20241116_d41cb988-d39d-4f0d-bda2-633f2bad6d1f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
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 41250-763-40 41250076340 355 mL in 1 BOTTLE (41250-763-40) 355 ml 2013-12-11 0000-00-00 No No Current 41250-763-50 41250076350 2 BOTTLE in 1 PACKAGE (41250-763-50) > 355 mL in 1 BOTTLE 2 bottle 2013-12-11 0000-00-00 No No Current