FDA.reportPublic FDA data

NDC 66992-310 - Xolox

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
66992-310
Manufacturer
Rebel Distributors Corp
Effective date
2011-04-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xolox - Rebel Distributors CorpRebel Distributors Corp2011-04-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6CXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
OXYCODONEACTIVE MOIETYCD35PMG570XOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXOLOX (OXYCODONE HCL AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP]1

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 57 of 187 · 3,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEFSA Store Inc. (Caring Mills)a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff2026-01-16WarningsExact identifier
unii: 362O9ITL9D
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
unii: 362O9ITL9D
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
unii: 362O9ITL9D
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
unii: 362O9ITL9D
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
unii: 362O9ITL9D
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.55d494b1-c828-4841-8f64-75b92cd54cb62026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
unii: 362O9ITL9D
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDECamber Pharmaceuticals Inc01db4606-d49c-4b10-a78a-1cf41880a9fb2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.2453d635-989d-4569-96b3-4efaf61cca712026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEMAJOR PHARMACEUTICALS6d249bc5-79c4-4c42-a71b-d667c75163db2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
unii: 362O9ITL9D
RoxyBondOXYCODONE HYDROCHLORIDEProtega Pharmaceuticals Inc72398542-8e0a-47b2-afeb-9ca5a1f150832026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
unii: 362O9ITL9D
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBIONPHARMA INC.4834aa7f-cb0c-ec58-e063-6394a90ae2fc2026-01-12WarningsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAvPAK244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f02026-01-12Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.9986aa04-c976-4654-8ad7-b97d2eecea932026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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