FDA.reportPublic FDA data

NDC 11822-3853 - DAY-NIGHT SEVERE COLD AND FLU

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
11822-3853
Package NDCs from labels
11822-3853-8
Manufacturer
RITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD
Effective date
2022-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
627T Rite Aid 11822 8554 Severe Cold & Flu Relief 24 ctRITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD2022-01-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3853-8DAY-NIGHT SEVERE COLD AND FLU8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86.25 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3853DAY-NIGHT SEVERE COLD AND FLU (DAY -ACETAMINOPHEN, DEXTROMETHORHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL NIGHT- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,) KIT [RITE AID]2Unmatched20220125_ad165e36-2704-3527-e053-2995a90a6d2a.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 8 of 365 · 7,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD NEIGHBOR PHARMACY MUCUS DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenf0aea945-1c18-4c6f-a7d1-6d56624011bb2026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
unii: 362O9ITL9D
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 362O9ITL9D
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Numb520SprayLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.350f0e25-fbdc-c0c0-e063-6294a90a50a02026-08-20WarningsExact identifier
unii: 04JA59TNSJ
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
cough dmDEXTROMETHORPHAN POLISTIREXAmazon.com Services LLC10f51748-17b1-459d-8cc6-acc4577290aa2026-08-20WarningsExact identifier
unii: 9D2RTI9KYH
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
rxcui: 2634364
rxcui: 1297288
rxcui: 1656815
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
rxcui: 1297288
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
rxcui: 1656815
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
unii: 495W7451VQ
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.5c96d033-bf7c-47de-aa0d-5998b3bf4a632026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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