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 39 of 362 · 7,231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENEywa Pharma Inc1da85ac1-46a2-4081-b533-4890ec9e04822026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
unii: 04JA59TNSJ
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
unii: 9D2RTI9KYH
mucus relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation84b5d83d-aea5-42ed-b20c-96d3b389c8c02026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
unii: 362O9ITL9D
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Maximum StrengthGUAIFENESINReckitt Benckiser LLC47f5323c-ee3a-400d-b133-31d9c286fafd2026-05-27WarningsExact identifier
unii: 495W7451VQ
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
sleep aidDOXYLAMINE SUCCINATERite Aid Corporation4b5fdb06-f205-4424-b4cb-dddef921485b2026-05-27WarningsExact identifier
unii: V9BI9B5YI2

Reported adverse events (FAERS/openFDA)#

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