Home NDC 49035-044 NiteTime Cold and Flu
Product NDC 49035-044
11-digit product format 490350044
Labeler code 49035
Product ID 49035-044_742f2d49-197c-49bd-9675-d503b77811c8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-31
Marketing end 2027-07-28
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes 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]
NDC exclude flag No
Current FDA listing Yes 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 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-044-12 NiteTime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 7 49035-044-24 NiteTime Cold and Flu 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 7 49035-044-24 NiteTime Cold and Flu 2 in 1 PACKAGE LIQUID 2 7
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 HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-044 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)] 6 Current NDC, Legacy NDC, 3 package rows 20241009_7b3c4793-9369-4331-bd5a-40f20b9df2b0.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 49035-044-12 49035004412 355 mL in 1 BOTTLE, PLASTIC (49035-044-12) 355 ml 2014-12-31 2027-07-28 No No Current 49035-044-24 49035004424 2 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24) / 355 mL in 1 BOTTLE, PLASTIC 2014-12-31 2027-07-28 No No Current