FDA.reportPublic FDA data

NDC 66689-401-01 - Oxycodone Hydrochloride

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
66689-401
Requested NDC
66689-401-01
Package NDCs from labels
66689-401-01, 66689-401-50
Manufacturer
VistaPharm, LLC
Effective date
2024-04-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone Hydrochloride - VistaPharm, LLCVistaPharm, LLC2024-04-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-401-502024-01-30C16284748780-11030e364-fb51-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. Oxycodone Hydrochloride oral solution CII Initial U.S. Approval: 1950

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-401OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC]24Legacy NDC20240427_d7dceba3-96dc-4593-bc8f-318052bdb520.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-401-01ML - Milliliter66689-401dc97b601-7870-4390-bd53-4ac15acfdb2b12012-07-24
66689-401-50ML - Milliliter66689-401b59ec39e-d4a4-48ac-8af9-69f5ed9c1b8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]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 7 of 37 · 736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENElite Laboratories, Inc.27fa8190-d334-4bb9-b277-d1f44db433e32026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacka1e539ba-2cb5-4815-8c58-37abfd978fa52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack7503ef9d-0fad-421f-951a-f35ab71f71c72026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack22f9eeaa-8aad-44f6-8258-e41edb60f8762026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke0079cc8-3642-47f0-9d14-28fd8f212c212026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1a190488-3444-43b0-b9c8-45c1eb371aad2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack35030c55-47e6-44cb-9d96-0c3cd5d0c2382026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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