Home NDC 57243-501 Nite-Time
Product NDC 57243-501
11-digit product format 572430501
Labeler code 57243
Product ID 57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bf
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form LIQUID
Route ORAL
Labeler Salado Sales, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-16
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 Nite-Time
Brand name suffix COLD/FLU ORIGINAL
Listing expiration 2026-12-31 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 57243-501-25 Nite-TimeCOLD/FLU ORIGINAL 177 mL in 1 BOTTLE LIQUID 177 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 SUCROSE INACTIVE INGREDIENT C151H8M554 NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-501 NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20231230_fcd24753-b42b-4d05-8379-0ec0351ab217.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 46 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013 CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Exact identifier application number: M013 Mejoral ACETAMINOPHEN, CAFFEINE OPMX LLC 0bccf571-fcb9-2dd5-e063-6294a90a5f16 2025-03-19 Warnings Exact identifier application number: M013 ARTRIFIN 24 CAPLETS ACETAMINOPHEN, ASPIRIN, CAFFEINE OPMX LLC e7f15c2b-a730-b54f-e053-2a95a90a3b3e 2025-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL TARGET Corporation 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 2025-03-17 Warnings Exact identifier application number: M013 Signature Select Effervescent Pain Relief ASPIRIN Safeway Inc. 304fca65-2867-c963-e063-6394a90a183f 2025-03-14 Warnings Exact identifier application number: M013
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 57243-501-25 57243050125 177 mL in 1 BOTTLE (57243-501-25) 177 ml 2012-01-16 0000-00-00 No No Current