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 201 of 339 · 6,763 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
SUKKHI Polyamino Sugar Condensate Massage CreamSUKKHI POLYAMINO SUGAR CONDENSATE MASSAGE CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd34aaf4ef-26dc-f87e-e063-6394a90a9a592025-05-08WarningsExact identifier
unii: PDC6A3C0OX
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAsclemed USA, Inc.702eb7c0-db4c-4729-b69e-99f64c63c7bd2025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc3febf0e0-b587-495a-9608-3a2dfbc327912025-05-07WarningsExact identifier
unii: 9D2RTI9KYH
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
unii: 362O9ITL9D
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
8hr arthritis pain reliefACETAMINOPHENMajor Pharmaceuticals31b3aaa2-8af2-670a-e063-6394a90a80032025-05-03WarningsExact identifier
unii: 362O9ITL9D
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBRBI-MART36aa5df7-8722-4b80-aa04-d869bc9443112025-05-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBI-MART0609120e-c348-494e-b4a0-863e77d7963a2025-05-01WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Phenylephrine hydrochloridePHENYLEPHRINE HYDROCHLORIDEAmneal Pharmaceuticals LLCfad93be4-32dd-44c1-a20f-2b0bb3b419292025-05-01Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HBRHarris Teeter17eee39b-5a7a-ba20-e063-6294a90ac3922025-04-29WarningsExact identifier
unii: 9D2RTI9KYH
ACETAMINOPHEN AND CODEINEACETAMINOPHEN AND CODEINEDirect_Rx8d7ca633-4448-3507-e053-2a95a90a12872025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
unii: 362O9ITL9D
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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