FDA.reportPublic FDA data

NDC 79481-0096-01 - sleep aid ultra

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
79481-0096
Requested NDC
79481-0096-01
Package NDCs from labels
79481-0096-0, 79481-0096-1, 79481-0096-01
Manufacturer
Meijer, Inc.
Effective date
2025-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meijer Distribution, Inc. Sleep Aid Ultra Drug FactsMeijer, Inc.2025-06-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0096-0sleep aid ultra24 in 1 CARTONTABLET244
79481-0096-0sleep aid ultra1 in 1 BLISTER PACKTABLET14
79481-0096-1sleep aid ultra12 in 1 CARTONTABLET124
79481-0096-1sleep aid ultra1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0096SLEEP AID ULTRA (DOXYLAMINE SUCCINATE) TABLET [MEIJER, INC.]3Current NDC, Legacy NDC, 4 package rows20250306_792632af-01c1-4a9b-99f4-8eb84d0fc389.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 14 of 21 · 414 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
unii: V9BI9B5YI2
sleep aidDOXYLAMINE SUCCINATEPublix Super Markets Inc377ebf03-c1d5-4362-98b3-032206df9e8e2025-05-23WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC37a88914-6234-4191-86f5-103c396c52af2025-05-20WarningsExact identifier
unii: V9BI9B5YI2
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
unii: V9BI9B5YI2
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
unii: V9BI9B5YI2
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
unii: V9BI9B5YI2
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
unii: V9BI9B5YI2
good sense sleep aid ultraDOXYLAMINE SUCCINATEL. Perrigo Company300826cf-6d0d-4efb-97aa-aa7dfff3add22025-04-02WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
up and up nighttime sleep aidDOXYLAMINE SUCCINATETarget Corporation24a0144d-cbfc-4d2f-873d-86adfa0468ca2025-04-02WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
CareOne Nighttime Sleep AidDOXYLAMINE SUCCINATEAmerican Sales Companyf8bfc874-53be-41e8-b59c-d538825761a82025-04-01WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
berkley and jensen sleep aidDOXYLAMINE SUCCINATEBJWC25f468a9-71d4-40f2-97bb-1c3ff5d4b7282025-03-31WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
topcare sleep aidDOXYLAMINE SUCCINATETopco Associates LLCc8b24ed8-34a1-4857-8fcb-6e3f9d4079032025-03-26WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
unii: V9BI9B5YI2
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
unii: V9BI9B5YI2
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
unii: V9BI9B5YI2
good sense sleep aid ultraDOXYLAMINE SUCCINATEL. Perrigo Company6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd2025-03-06WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
dg health sleep aidDOXYLAMINE SUCCINATEDolgencorp Inca4c6b400-7fa6-4ad1-9d39-d34621eb91a62025-03-05WarningsExact identifier
application number: ANDA040167
rxcui: 1101446
unii: V9BI9B5YI2
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
unii: V9BI9B5YI2
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Night Time Sleep AidDOXYLAMINE SUCCINATEAdvanced Rx LLCdb8b730a-1553-4682-96bf-41e670ed03472025-02-26WarningsExact identifier
rxcui: 1101446
unii: V9BI9B5YI2

Reported adverse events (FAERS/openFDA)#

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