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 15 of 189 · 3,771 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
unii: 362O9ITL9D
Pentrexcilina DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
unii: 362O9ITL9D
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp5fa848ef-35ee-4e05-8ff2-781d034cf6ac2026-07-14WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
unii: 362O9ITL9D
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack8a4cf981-37f7-4bc9-a9d7-b134a5fd08942026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
unii: 362O9ITL9D
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
unii: 362O9ITL9D
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
unii: 362O9ITL9D
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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