FDA.reportPublic FDA data

NiteTime Cold and Flu

Product NDC
49035-044
11-digit product format
490350044
Labeler code
49035
Product ID
49035-044_742f2d49-197c-49bd-9675-d503b77811c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
Marketing end
2027-07-28
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
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
NiteTime Cold and Flu

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-044-12NiteTime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID3557
49035-044-24NiteTime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID3557
49035-044-24NiteTime Cold and Flu2 in 1 PACKAGELIQUID27

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1
WATERINACTIVE INGREDIENT059QF0KO0RNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WALMART STORES, INC.)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-044NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]6Current NDC, Legacy NDC, 3 package rows20241009_7b3c4793-9369-4331-bd5a-40f20b9df2b0.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 148 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB9cbb3ab1-5f32-421e-9f28-d99be9447e9f2024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb791902-e2c3-5662-e053-2995a90a37fd2024-10-21WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBc3849b66-697f-4f6e-93ab-76de031b3c702024-10-21WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBee1477ed-00c4-46ea-bc57-aef214076dc22024-10-21WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB774e8bee-1ab5-4587-82e4-31da8ec835442024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba8ade-3441-f243-e053-2995a90a12302024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba22ac-c38d-a42e-e053-2995a90a69002024-10-21WarningsExact identifier
application number: M012
Diphenhydramine HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst25034563-6422-daf6-e063-6394a90af9802024-10-21WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER198add5f-20b7-75b0-e063-6394a90a6bd42024-10-21WarningsExact identifier
application number: M012
Tukol Honey Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAdae33df8-2294-4242-a25b-2d89d1f63b232024-10-18WarningsExact identifier
application number: M012
sinus pressure and pain peACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa7931e4c-8a5e-66e2-e053-2995a90af2a42024-10-18WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense570ea130-6a99-446e-9f97-14fc958090062024-10-18WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa14999e3-a9d9-0a1f-e053-2995a90af7b32024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEa793000b-3ef9-5662-e053-2a95a90ad0da2024-10-18WarningsExact identifier
application number: M012
Cold Multi-Symptom Daytime and NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense37455f86-ab21-472b-9e80-40324699f3ca2024-10-18WarningsExact identifier
application number: M012
Head Congestion Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3396a27-8643-71fa-e053-2a95a90a713d2024-10-18WarningsExact identifier
application number: M012
Head Congestion Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGOODSENSEe3397f69-3267-ca0b-e053-2995a90a7db52024-10-18WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGoodSense747512a2-3b6d-496b-ab80-8190603141632024-10-18WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN9daf7f40-d9c5-4367-be41-894208358fc12024-10-18WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen608e6808-29e4-40bc-8496-24c092681a1b2024-10-18WarningsExact 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 SolutionPSN7b3c4793-9369-4331-bd5a-40f20b9df2b07
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD7b3c4793-9369-4331-bd5a-40f20b9df2b07
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY7b3c4793-9369-4331-bd5a-40f20b9df2b07
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY7b3c4793-9369-4331-bd5a-40f20b9df2b07
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY7b3c4793-9369-4331-bd5a-40f20b9df2b07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-044-1249035004412355 mL in 1 BOTTLE, PLASTIC (49035-044-12) 355 ml2014-12-312027-07-28NoNoCurrent
49035-044-24490350044242 BOTTLE, PLASTIC in 1 PACKAGE (49035-044-24) / 355 mL in 1 BOTTLE, PLASTIC2014-12-312027-07-28NoNoCurrent