FDA.reportPublic FDA data

Original Night-Time

Product NDC
53943-501
11-digit product format
539430501
Labeler code
53943
Product ID
53943-501_46538946-6c44-dce2-e063-6394a90ae990
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
LIQUID
Route
ORAL
Labeler
Discount Drug Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-21
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53943-501-28e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53943-501-289bebd1f3094a…5416666fcb17…

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
Original Night-Time
Brand name suffix
MULTI-SYMPTOM COLD/FLU RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043400Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e243033b-6603-4c3e-a330-e7c7de51f69dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-501-282020-12-31C16284748780-19d75b9d0-9043-f424-e053-dadaa90a57cee243033b-6603-4c3e-a330-e7c7de51f69d
53943-501-282020-01-31C16284748780-19d75b9d0-9043-f424-e053-dadaa90a57cee243033b-6603-4c3e-a330-e7c7de51f69d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-501-28Original Night-TimeMULTI-SYMPTOM COLD/FLU RELIEF354 mL in 1 BOTTLELIQUID3546

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
SUCROSEINACTIVE INGREDIENTC151H8M554ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-501ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]5Current NDC, Legacy NDC, 1 package rows20241222_e243033b-6603-4c3e-a330-e7c7de51f69d.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 59 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Suphedrine PE Sinus Congestion Non-DrowsyPHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEb9122fd0-0bed-4302-9bbe-cd6a46d298182026-01-12WarningsExact identifier
application number: M012
Sinu-Phen Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business Groupc66e0b52-5531-4a84-ae90-8a26d27df1ec2026-01-12WarningsExact identifier
application number: M012
SU PHEDRINE PE SINUS CONGESTIONPHENYLEPHRINE HCLSalado Sales, Inc.ba075ff7-4e26-4856-8335-0c7dd4e198ea2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCbab078bb-f6b0-4394-84de-92b2c582b5da2026-01-12WarningsExact identifier
application number: M012
Nasal Decongestant PE Non-Drowsy Maximum StrengthPHENYLEPHRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d2026-01-12WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacy022c3083-c611-47d0-aa93-d6c7612e7a472026-01-11WarningsExact identifier
application number: M012
CVS Health Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCVS Pharmacybf73d15a-9d68-42fa-bfee-d25748215f972026-01-11WarningsExact identifier
application number: M012
GUAIFENESIN 400MG CAPLETSGUAIFENESINGendose Pharmaceuticals, LLCe7b82ec7-ef23-50c1-e053-2a95a90a662f2026-01-10WarningsExact identifier
application number: M012
Daytime Cold and FluDAYTIME COLD AND FLUAllegiant Health69ed2da0-16b2-49eb-91b4-cc5cf328c8172026-01-09WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLHY-VEE, INC47f81e54-0ce4-439d-e063-6294a90a2abe2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutionsa5809774-ed52-4f54-b48e-888631e0223d2026-01-09WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLA-S Medication Solutions5767f546-a751-4583-a8b7-971175c27ef02026-01-09WarningsExact identifier
application number: M012
Thompson Cough and Cold Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,Thompsone77725b1-15da-35bd-e053-2a95a90ad6ba2026-01-08WarningsExact identifier
application number: M012
Mucosan Childrens Multi-Symptom GrapeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.266c8cce-cdf9-557d-e063-6394a90a9bc32026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom HoneyDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.2669c620-ab70-abaa-e063-6394a90a58e72026-01-08WarningsExact identifier
application number: M012
Mucosan Multi-Symptom CherryDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26b8c06d-4a72-3979-e063-6394a90a96d72026-01-08WarningsExact identifier
application number: M012
Mucosan Max with AcetaminophenACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEMenper Distributors, Inc.26a4861b-5d8e-9ec6-e063-6394a90af5772026-01-08WarningsExact identifier
application number: M012
Mucosan Severe Multi-SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMenper Distributors, Inc.26a69342-f65f-cb46-e063-6394a90ade102026-01-08WarningsExact identifier
application number: M012
HyVee Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.e4e15c13-f583-4484-a5f0-f04c39c7b7c92026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non DrowsyASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a355d987-77ce-9e32-e053-2995a90a64312026-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNe243033b-6603-4c3e-a330-e7c7de51f69d6
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe243033b-6603-4c3e-a330-e7c7de51f69d6
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe243033b-6603-4c3e-a330-e7c7de51f69d6
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe243033b-6603-4c3e-a330-e7c7de51f69d6
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe243033b-6603-4c3e-a330-e7c7de51f69d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-501-2853943050128354 mL in 1 BOTTLE (53943-501-28) 354 ml2014-10-210000-00-00NoNoCurrent