FDA.reportPublic FDA data

NDC 76162-680 - MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct

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
76162-680
Manufacturer
Topco Associates LLC
Effective date
2025-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sinus Relief Day - Topco Associates LLCTopco Associates LLC2025-12-10HUMAN OTC DRUG LABEL

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 414 of 420 · 8,387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MucinexGUAIFENESINProficient Rx LPf3ade814-2759-4ad0-a196-210e84d8cde92021-01-01WarningsExact identifier
unii: 495W7451VQ
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.943638b7-527b-4724-a6b7-2018862396d42020-11-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAsclemed USA, Inc.82d8b70f-aebf-4b9a-89b1-183fc9e2ff592020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEAsclemed USA, Inc.3f83ba75-9415-4ace-9416-04d666c005a22020-10-30Boxed warning, WarningsExact identifier
unii: 362O9ITL9D
JEGAMSAN ExtractLONICERA FLOWER, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROMIDEI World Pharmaceutical Co., Ltd.af695c7e-1ad2-ad98-e053-2995a90a2edf2020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
SoCheongRyong Tang ExtractGINGER, CHLORHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af68634f-eb0a-64e7-e053-2a95a90a5df22020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
MaekMunDong Tang ExtractJUJUBE, ACETAMINOPHEN, CHLORHENIRAMINE MALEATEI World Pharmaceutical Co., Ltd.af640819-1187-3254-e053-2995a90a29572020-09-15WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESagent Pharmaceuticalsb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d2020-07-10Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
equate cough dmDEXTROMETHORPHAN POLISTIREXWal-Mart Stores Inc5f72c4ad-1c30-41ea-b39c-7f4bb3deced62020-07-08WarningsExact identifier
unii: 9D2RTI9KYH
Cough DMDEXTROMETHORPHAN POLISTIREXCVS Pharmacy956f0bd4-3266-4754-9bd2-ac480e3bcbce2020-05-27WarningsExact identifier
unii: 9D2RTI9KYH
AcetaminophenACETAMINOPHENSandoz Inc3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce92020-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
unii: 362O9ITL9D
SorbitolSORBITOLBaxter Healthcare Corporationaea0b5a1-444b-4330-a3ce-26485dbbfe752019-12-31Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
CareOne Cough DMDEXTROMETHORPHAN POLISTIREXAmerican Sales Company42f67a3c-8cd7-44a6-8e54-08fb8449e8d72019-12-09WarningsExact identifier
unii: 9D2RTI9KYH
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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