FDA.reportPublic FDA data

NDC 11822-3855 - DAY MAXIMUM STRENGTH COLD AND FLU RELIEF

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
11822-3855
Package NDCs from labels
11822-3855-9
Manufacturer
RITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD
Effective date
2022-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENYLEPHRINE - RITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTDRITE AID | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD2022-01-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3855-9DAY MAXIMUM STRENGTH COLD AND FLU RELIEF16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED165 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3855DAY MAXIMUM STRENGTH COLD AND FLU RELIEF (DAY -ACETAMINOPHEN, DEXTROMETHORHAN HBR, PHENYLEPHRINE HCL) KIT [RITE AID]2Unmatched20220125_ad24b7e4-5874-6c3d-e053-2a95a90a2124.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 70 of 348 · 6,951 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
unii: 362O9ITL9D
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEAcella Pharmaceuticals, LLC1045e307-f60d-482d-8e06-40e72b84c6512026-03-16Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
unii: 362O9ITL9D
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: V9BI9B5YI2
unii: 362O9ITL9D
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch Prepackc83366d9-db60-45eb-9c2b-a2c58d45c82c2026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
unii: 362O9ITL9D
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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