FDA.reportPublic FDA data

Meijer Nighttime Cold and Flu

Product NDC
41250-869
11-digit product format
412500869
Labeler code
41250
Product ID
41250-869_3e8cb76c-261d-4034-bdef-1eedd2193f54
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-25
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes
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
Meijer Nighttime Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
TRIPROLIDINE HYDROCHLORIDE2.5 mg/20mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-869-06Meijer Nighttime Cold and Flu180 mL in 1 BOTTLESOLUTION1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-869MEIJER NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [MEIJER DISTRIBUTION INC.]6Current NDC, Legacy NDC, 1 package rows20241019_98bf18b0-b489-4a31-8e1e-fadfd399ee00.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 159 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare childrens allergyDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC6b784cde-3152-4421-a825-dd1fc601aa7a2024-07-17WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
application number: M012
basic care allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC7d237d37-21c7-476d-a8b7-d91ea1b472ee2024-07-16WarningsExact identifier
application number: M012
Berkley and Jensen Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWCb52fc311-8853-4116-941b-8be35456abba2024-07-16WarningsExact identifier
application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreens0b9a4438-7d13-484c-a614-2dedc24974dc2024-07-16WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEPublix Super Markets Inc23a98385-28cc-4fac-8c87-b3ced81065322024-07-16WarningsExact identifier
application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe0.05% OXYMETAZOLINEWalgreens Companyaad01028-cbe0-4c10-adbc-d157bfa5af092024-07-16WarningsExact identifier
application number: M012
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
application number: M012
Maximum Strength Cold TabsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEJHK DBA American Safety & First Aide7d4fe9a-eb09-4266-90c9-290f61ce6ad02024-07-15WarningsExact identifier
application number: M012
ACTIDOM DACHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC7797c22e-ffeb-4798-9fb6-aa64cf077ba72024-07-15WarningsExact identifier
application number: M012
Nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1cf3064d-4ddd-63b9-e063-6294a90aa5472024-07-11WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLTARGET CORPORATION1ccbdb53-3f70-28da-e063-6394a90a9ae02024-07-09WarningsExact identifier
application number: M012
AXIV Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1cd2a6f1-31ad-e507-e063-6394a90aba582024-07-09WarningsExact identifier
application number: M012
Poly Hist ForteDOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aa0015b-8fc1-7951-e053-2a95a90a8e722024-07-09WarningsExact identifier
application number: M012
DECONEX DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.8aab8e5c-1633-2e5a-e053-2a95a90adcc52024-07-09WarningsExact identifier
application number: M012
Deconex IRGUAIFENESIN AND PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.4710095e-3dae-4a39-8a98-873012e1f0032024-07-09WarningsExact identifier
application number: M012
Diabetic Tussin Sore Throat and Cough CherryBENZOCAINE AND DEXTROMETHORPHAN HBRMEDTECH PRODUCTS INCe9327079-e0fc-4c95-b1d5-bc1b74870c9b2024-07-09WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporationfac859a4-e23a-4879-af6c-26368455506d2024-07-05WarningsExact identifier
application number: M012
Severe Throat DropsMENTHOL ICETarget Corporation Inc.1876b221-fa60-5269-e063-6394a90a69632024-07-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2173667acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral SolutionPSN98bf18b0-b489-4a31-8e1e-fadfd399ee007
2173667acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral SolutionSCD98bf18b0-b489-4a31-8e1e-fadfd399ee007
2173667acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral SolutionSY98bf18b0-b489-4a31-8e1e-fadfd399ee007
2173667APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral SolutionSY98bf18b0-b489-4a31-8e1e-fadfd399ee007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-869-0641250086906180 mL in 1 BOTTLE (41250-869-06) 180 ml2020-05-250000-00-00NoNoCurrent