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 43 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coated Aspirin ASPIRIN L.N.K. International, Inc. e077fe14-62bb-462b-bfa3-8a83c06c22f1 2025-07-11 Warnings Exact identifier application number: M013 EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TIME CAP LABS 59482917-f80b-4bed-9218-068b35366eb3 2025-07-11 Warnings Exact identifier application number: M013 Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Exact identifier application number: M013 Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Exact identifier application number: M013 topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Exact identifier application number: M013 equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Exact identifier application number: M013 Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN Advanced Rx LLC ad0d6a5c-eee9-406c-8d7f-1df9b45f5340 2025-07-02 Warnings Exact identifier application number: M013 EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE Lil' Drug Store Products, Inc. ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 2025-07-02 Warnings Exact identifier application number: M013 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE Genexa Inc. 18835205-a9e3-15c2-e063-6394a90a8107 2025-07-02 Warnings Exact identifier application number: M013 FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 11c9712d-c3b2-49cd-9c2b-0f57190c954e 2025-07-02 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN United Natural Foods, Inc. dba UNFI 979973c1-661a-4384-8b92-fd901ebde558 2025-07-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN CVS Pharmacy f6bbce1c-9790-4ca4-847f-579c594ffe0b 2025-07-01 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS 07d2e322-2465-79e5-e063-6294a90a5ea4 2025-06-30 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 66c0cf26-357b-4722-9100-3b86d507a8cd 2025-06-30 Warnings Exact identifier application number: M013 ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE Kroger Company bc019c9e-8fac-5fd3-e053-2a95a90a7ccd 2025-06-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN Extra Strength ACETAMINOPHEN TIME CAP LABS INC fd24d0e0-4f36-42d3-9149-2fb957690305 2025-06-25 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