Home NDC 21130-044 Nighttime Cold and Flu Relief
Product NDC 21130-044
11-digit product format 211300044
Labeler code 21130
Product ID 21130-044_72bb25dc-3f0f-4afe-b967-dc5f14ff1767
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form LIQUID
Route ORAL
Labeler Safeway, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-06-30
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
Listing certified through 2027-12-31
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 Nighttime Cold and Flu Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043400 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 21130-044-08 Nighttime Cold and Flu Relief 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 9 21130-044-12 Nighttime Cold and Flu Relief 355 mL in 1 BOTTLE LIQUID 355 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 POLYETHYLENE GLYCOL 300 INACTIVE INGREDIENT 5655G9Y8AQ NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-044 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20241105_164b2559-2d3f-431e-a03c-07e86731af5c.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 21130-044-08 21130004408 237 mL in 1 BOTTLE, PLASTIC (21130-044-08) 237 ml 2014-06-30 0000-00-00 No No Current 21130-044-12 21130004412 355 mL in 1 BOTTLE (21130-044-12) 355 ml 2014-06-30 0000-00-00 No No Current