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 173 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORP0b1e230d-4354-bf61-e063-6394a90a2b2f2023-12-09WarningsExact identifier
application number: M012
Phenylephrine HCl Maximum StrengthPHENYLEPHRINE HCLA-S Medication Solutionsfcb769d0-aa45-48eb-acd0-2247b392f9fe2023-12-09WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0bf915af-a016-0a46-e063-6394a90aacf52023-12-08WarningsExact identifier
application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and FluDAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCITARGET Corporation0bf9c0df-7676-3060-e063-6394a90a16c72023-12-08WarningsExact identifier
application number: M012
NazalNAPHAZOLINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.4d4043f8-5ed3-4027-beb6-687db13082022023-12-06WarningsExact identifier
application number: M012
Family Wellness OxymetazolineOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)8b4557d4-74a0-400f-ad7a-6d31473b3c672023-12-06WarningsExact identifier
application number: M012
Childrens Plus FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1598e6f8-08ee-4216-a5ab-76cad37b09a72023-12-06WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
application number: M012
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.afc95c82-18da-487b-b4bb-51e0be0378da2023-12-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Companya14643a1-3d91-491a-88d6-22dccde979382023-12-04WarningsExact identifier
application number: M012
TopCare Day Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC14d53907-a4a2-4a0f-b2d6-33474945f9e12023-12-04WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLProficient Rx LP62934d0f-b23d-4c03-9d60-a7bad41f9b422023-12-01WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LPb1c849e5-8003-4fd3-811d-6a927523e3532023-12-01WarningsExact identifier
application number: M012
Akin Expectorant Formula Strawberry BananaGUAIFENESINSouthern Sales & Service, Inc.b63b0133-d2da-432b-a154-9e77535bbef92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DM Strawberry BananaDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSouthern Sales & Service, Inc.7a81efd8-775d-455e-860f-f3e3b369a0a72023-11-29WarningsExact identifier
application number: M012
AkinGUAIFENESINSouthern Sales & Service, Inc.bb2c9f21-6765-4286-bd71-de01cdf4c4e92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESimpex Pharma Pvt. Ltd82771f6a-8b3d-4ffa-8b35-09c2faf3582c2023-11-29WarningsExact 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