Meijer Nitetime Cold and Flu Relief

Product NDC
79481-6921
11-digit product format
794816921
Labeler code
79481
Product ID
79481-6921_64d075d8-b091-4fc3-b926-b4972c4fe979
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
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
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 Nitetime Cold and Flu Relief
Listing expiration
2027-12-31

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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-6921-2Meijer Nitetime Cold and Flu Relief354 mL in 1 BOTTLESOLUTION3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-6921MEIJER NITETIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]2Current NDC, 1 package rows20241023_f7cc9b50-8199-4df7-97a7-b09358f2931b.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 66 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier ValueCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2de803-900d-02f4-e063-6394a90a84cc2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMON SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307f3a7-f6e7-8a5d-e063-6394a90ab7eb2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2e8fbe-c1c3-79b1-e063-6394a90a4d732025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2dfcc3-e599-3102-e063-6394a90ad54a2025-12-29WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.2a2ead3c-b4d5-ee8f-e063-6294a90a3c392025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f42644-045b-c4b3-e063-6294a90a48fd2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f45499-bf14-03e4-e063-6394a90a535c2025-12-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3ddcc-9d4e-f1b1-e063-6294a90ac86f2025-12-29WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPXiamen Kang Zhongyuan Biotechnology Co., Ltd.274a5551-4989-d8fe-e063-6394a90aeabf2025-12-29WarningsExact identifier
application number: M012
MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough DropsMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2acaa-2cc8-a999-e063-6294a90a15ce2025-12-29WarningsExact identifier
application number: M012
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a92ecc-6a9c-b569-e063-6394a90a8bcb2025-12-29WarningsExact identifier
application number: M012
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
application number: M012
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINLlorens Pharmaceutical International Division, Inc.77c16288-68c4-476c-995f-86f5056632702025-12-29WarningsExact identifier
application number: M012
Tusnel DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.fe457e6d-422d-496c-bcb9-33594f3c42ff2025-12-29WarningsExact identifier
application number: M012
Tusnel DiabeticDEXTROMETHORPHAN, GUAIFENESINLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION66b3c094-809e-4d2c-bc15-46563de685cb2025-12-29WarningsExact identifier
application number: M012
FortifyMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M012
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
application number: M012
Winco Foods Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLWinCo Foods, LLCf54eb60d-c602-1272-e053-2995a90aa95a2025-12-28WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLCad4d74a8-a762-4378-9016-f7c83421073e2025-12-26WarningsExact 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 SolutionPSNf7cc9b50-8199-4df7-97a7-b09358f2931b3
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf7cc9b50-8199-4df7-97a7-b09358f2931b3
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf7cc9b50-8199-4df7-97a7-b09358f2931b3
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf7cc9b50-8199-4df7-97a7-b09358f2931b3
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf7cc9b50-8199-4df7-97a7-b09358f2931b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-6921-279481692102354 mL in 1 BOTTLE (79481-6921-2) 354 ml2023-03-31NoNoCurrent