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 89 of 187 · 3,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAvPAK5174bd9a-b777-a6e3-f72f-c16082ee67d32025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC1539dc44-15a0-153b-e063-6294a90a9d452025-10-21WarningsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC3d1bb61c-15db-4eba-aba9-cfbcbc7b30e02025-10-21WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackee4b164d-7ee2-4c19-b1a3-cb60c66767862025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI311e2b6b-21cb-4b4c-a78d-a0732d29602f2025-10-21WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack94ba2279-440e-4eaf-ad19-04d90a5c4c102025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack177c4cd8-80dd-4ed7-9e12-dcec70e0278e2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health Packagingaa7ac2bf-d9ed-445d-b394-4d3fe39780ca2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
unii: 362O9ITL9D
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
unii: 362O9ITL9D
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack08977126-9671-4d87-9724-1599ca86e1812025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Butalbital And AcetaminophenBUTALBITAL AND ACETAMINOPHENLarken Laboratories, Inc.326c83fc-afed-45ad-9c87-f47968fa1d2a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
unii: 362O9ITL9D
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
ACETAMINOPHEN 500 MGACETAMINOPHENASCLEMED USA INC.db8e6702-88ac-4db2-9dd8-7d0ed997c2b52025-10-14WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyfa33f6ef-522b-4630-9716-92371d9cd24a2025-10-14WarningsExact identifier
unii: 362O9ITL9D
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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