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 130 of 440 · 8,781 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Brompheniramine, Pseudoephedrine, DextromethorphanBROMPHENIRAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHANAscend Laboratories, LLC036b587a-7bfe-4149-bd05-34a37e3e84b62026-01-02Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEHikma Pharmaceuticals USA Inc.6e0e8abc-512b-42f7-8323-434c589edecf2026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: 04JA59TNSJ
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
unii: 495W7451VQ
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 495W7451VQ
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
unii: 362O9ITL9D
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Cough DMDEXTROMETHORPHAN POLISTIREXMeijer Distribution Inc6bdfa599-7898-4c05-927c-52fb82e0e6862026-01-02WarningsExact identifier
unii: 9D2RTI9KYH
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
unii: 362O9ITL9D
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
unii: 362O9ITL9D
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLJC SALES490b2d1e-3a1d-1a52-e063-6394a90a00ba2026-01-01WarningsExact identifier
application number: M012
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLNingbo Liyuan Daily Chemical Products Co., Ltd.4947540b-73c9-d44a-e063-6294a90a9d372026-01-01WarningsExact identifier
application number: M012
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAmneal Pharmaceuticals of New York LLCd51600e2-2f73-483c-9b2e-f142bafff16d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
unii: 495W7451VQ
Zicam Extreme Congestion ReliefOXYMETAZOLINE HYDROCHLORIDEChurch & Dwight Co., Inc.ccada339-656c-a461-e053-2a95a90a34792025-12-31WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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