FDA.reportPublic FDA data

NDC 41250-441-00 - Sleep Aid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
41250-441
Requested NDC
41250-441-00
Package NDCs from labels
41250-441-64, 41250-441-00, 41250-441-01
Manufacturer
Meijer Distribution Inc
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sleep Aid - Meijer Distribution IncMeijer Distribution Inc2026-03-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-441-00Sleep Aid96 in 1 BOTTLETABLET965
41250-441-01Sleep Aid1 in 1 CARTONTABLET15
41250-441-64Sleep Aid1 in 1 BLISTER PACKTABLET15
41250-441-64Sleep Aid32 in 1 CARTONTABLET325

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3

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 4 of 21 · 414 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
unii: V9BI9B5YI2
Sleep AidDOXYLAMINE SUCCINATEStrategic Sourcing Services LLCeddec8bc-2bed-4bc5-a1c2-39424a6998382026-05-13WarningsExact identifier
rxcui: 1101446
unii: V9BI9B5YI2
Sleep AidDOXYLAMINE SUCCINATEWal-Mart Stores Inc71e0cef1-6195-4b67-9c1f-b4e5fbeae53c2026-05-13WarningsExact identifier
rxcui: 1101446
unii: V9BI9B5YI2
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
unii: V9BI9B5YI2
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
unii: V9BI9B5YI2
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
unii: V9BI9B5YI2
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
unii: V9BI9B5YI2
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5150ff85-85bb-9cd9-e063-6294a90a11442026-05-08WarningsExact identifier
unii: V9BI9B5YI2
sleep aidDOXYLAMINE SUCCINATEWalgreen Company489ee606-15f4-4032-a62b-35c8844f1a262026-05-08WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
NitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc8aa6492b-1723-4c6b-82ee-4f800301c6ad2026-05-06WarningsExact identifier
unii: V9BI9B5YI2
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
unii: V9BI9B5YI2
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
unii: V9BI9B5YI2
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
unii: V9BI9B5YI2
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
unii: V9BI9B5YI2
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
unii: V9BI9B5YI2
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
unii: V9BI9B5YI2
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
unii: V9BI9B5YI2
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
unii: V9BI9B5YI2
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
unii: V9BI9B5YI2
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
unii: V9BI9B5YI2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.