Home NDC 53942-501 NIGHT-TIME
Product NDC 53942-501
11-digit product format 539420501
Labeler code 53942
Product ID 53942-501_0dac168e-499b-525a-e063-6294a90a089a
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form LIQUID
Route ORAL
Labeler DeMoulas Market Basket
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-10-01
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 NIGHT-TIME
Brand name suffix MULTI-SYMPTOM COLD/FLU Original
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 53942-501-28 NIGHT-TIMEMULTI-SYMPTOM COLD/FLU Original 354 mL in 1 BOTTLE LIQUID 354 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 SUCROSE INACTIVE INGREDIENT C151H8M554 NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-501 NIGHT-TIME MULTI-SYMPTOM COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET] 8 Current NDC, Legacy NDC, 1 package rows 20231230_eb24323f-82a1-4ba3-9359-fe81571c3fba.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 9 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 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 53942-501-28 53942050128 354 mL in 1 BOTTLE (53942-501-28) 354 ml 2012-10-01 0000-00-00 No No Current