FDA.reportPublic FDA data

meijer Maximum Strength Nighttime Cough DM

Product NDC
41250-758
11-digit product format
412500758
Labeler code
41250
Product ID
41250-758_b1e89574-8e65-4736-bcf3-43f1668b2021
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-14
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
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
meijer Maximum Strength Nighttime Cough DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 mg/20mL

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-758-04meijer Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION19
41250-758-04meijer Maximum Strength Nighttime Cough DM118 mL in 1 BOTTLESOLUTION1189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-758MEIJER MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]8Current NDC, Legacy NDC, 2 package rows20241023_a99f36b1-6cf4-496e-a347-08aa21cba163.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 79 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b2025-12-09WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc9a32bc6d-0499-48fa-a6ad-702c8a28bf5f2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp5015a380-a229-4eff-8e31-528065c6ed642025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teetercaf59320-5b48-4533-bda9-7b03a2fde0b52025-12-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
application number: M012
Walgreens Childrens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a7226-84b9-26d7-e063-6394a90a99b92025-12-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINMeijer Distribution Inc8ed5b802-a26e-45b4-a696-bc64dbac47332025-12-09WarningsExact identifier
application number: M012
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEFamily Dollar (FAMILY WELLNESS)2c431220-c61b-4ad5-9ad2-58ccaee2d1c32025-12-09WarningsExact identifier
application number: M012
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fdd0dadc-5313-4f6e-aef5-ca853efe5c4d2025-12-08WarningsExact identifier
application number: M012
MucolyteGUAIFENESINRising Pharma Holdings, Inc.e4091aaf-44e3-4701-9986-aff248a2f1b82025-12-08WarningsExact identifier
application number: M012
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLAmerican Sales47f504d5-3ec5-5227-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLAmerican Sales4893ac0a-7769-5657-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLAmerican Sales45e891ea-2f2a-31b7-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNa99f36b1-6cf4-496e-a347-08aa21cba1639
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDa99f36b1-6cf4-496e-a347-08aa21cba1639
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYa99f36b1-6cf4-496e-a347-08aa21cba1639
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYa99f36b1-6cf4-496e-a347-08aa21cba1639

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-758-04412500758041 BOTTLE in 1 CARTON (41250-758-04) / 118 mL in 1 BOTTLE1 bottle2017-03-140000-00-00NoNoCurrent