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 7 of 365 · 7,288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: 362O9ITL9D
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: 362O9ITL9D
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
unii: 362O9ITL9D
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: 362O9ITL9D
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162026-08-26WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINHyVee Inc6bce66d6-e76a-4273-aff9-7ee6adc189802026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
good neighbor pharmacy mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergenf7925a6b-7029-4389-bf1b-8c0f5e79b9502026-08-25WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DG health mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inca95401cc-349e-435a-b953-4d8fd1f547442026-08-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: 362O9ITL9D
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Feverall ChildrensACETAMINOPHENSun Pharmaceutical Industries, Inc.861e2987-5473-45b0-b2a6-f980a9b0e8092026-08-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
unii: 362O9ITL9D
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsExact identifier
unii: 495W7451VQ
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
unii: 362O9ITL9D
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGPar Health USA, LLCde265fd1-bc22-4da1-aab5-b5fedd649c8b2026-08-24Warnings, Adverse reactionsExact identifier
unii: V9BI9B5YI2
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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