FDA.reportPublic FDA data

NDC 11822-5347 - Cold and Flu Severe, Daytime, Nighttime

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
11822-5347
Package NDCs from labels
11822-5347-9
Manufacturer
Rite Aid Corporation | LNK International, Inc.
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rite Aid 44-503A473CRite Aid Corporation | LNK International, Inc.2026-05-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5347-9Cold and FluSevere, Daytime, Nighttime8 in 1 BLISTER PACKTABLET, FILM COATED165 mg8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5347COLD AND FLU SEVERE, DAYTIME, NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [RITE AID CORPORATION]7Unmatched20250512_a0bff310-2d35-4a18-815b-8386e44730a2.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 281 of 431 · 8,603 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
unii: 15FIX9V2JP
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEAphena Pharma Solutions - Tennessee, LLCd53bf9b7-1652-4287-a0c1-e89f6f0cb7f12025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
APADAZBENZHYDROCODONE AND ACETAMINOPHENZevra Therapeutics, Inc.0590d4e5-7107-4015-a6a8-deac14265aa22025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 495W7451VQ
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
GeriCare Liquid Pain ReliefACETAMINOPHENGeri-Care Pharmaceuticals, Corp85a074da-14b7-4db5-9d47-8ad19f5207212025-01-06WarningsExact identifier
unii: 362O9ITL9D
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
unii: 15FIX9V2JP
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jucre Rebirth BBTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, NIACINAMIDE, ADENOSINENATURECELL CO., LTD.2ab403df-29b3-75af-e063-6394a90a6ca42025-01-02WarningsExact identifier
unii: 15FIX9V2JP
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
unii: 15FIX9V2JP
PUBLIX SUPER MARKETS INCACETAMINOPHEN, ASPIRIN AND CAFFEINEPUBLIX SUPER MARKETS INC08a46808-2bb2-0b40-e063-6394a90af80e2025-01-02WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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