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 102 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact 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