FDA.reportPublic FDA data

NDC 59385-055-01 - ELYXYB - celecoxib

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
59385-055
Requested NDC
59385-055-01
Package NDCs from labels
59385-055-01, 59385-055-06, 59385-055-02, 59385-055-22
Manufacturer
BioDelivery Sciences International Inc
Effective date
2021-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELYXYB - celecoxib - BioDelivery Sciences International IncBioDelivery Sciences International Inc2021-10-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-055-062025-01-30C16284748780-12cef2736-9443-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998
59385-055-222025-01-30C16284748780-12cef2736-9443-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59385-055-01ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.81
59385-055-02ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.81
59385-055-06ELYXYB - celecoxib6 in 1 CARTONLIQUID61
59385-055-22ELYXYB - celecoxib1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-055ELYXYB - CELECOXIB (CELECOXIB) LIQUID [BIODELIVERY SCIENCES INTERNATIONAL INC]1Legacy NDC, 4 package rows20220101_a0bfcba9-0af6-4b45-80e3-c4c94065b777.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59385-055-01ML - Milliliter59385-05595ea0cda-0b6e-4c36-82c5-bb49474c1aec12021-12-08
59385-055-06ML - Milliliter59385-0556d45fad7-3520-4faf-a2e3-3476d373308912021-12-08

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 2 of 167 · 3,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsExact identifier
unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5aaaff8f-5f6b-d575-e063-6394a90a1edc2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight SmoresALCOHOLChurch & Dwight Co., Inc.5aab0ca1-b3c4-964f-e063-6294a90a263f2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry FizzALCOHOLChurch & Dwight Co., Inc.5aab1faa-d884-1a55-e063-6394a90ad6e22026-09-04WarningsExact identifier
unii: 3K9958V90M
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed3796ee-3078-e850-e053-2a95a90a318a2026-09-03WarningsExact identifier
unii: 3K9958V90M
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed63bd55-941f-9785-e053-2995a90a59522026-09-03WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
biom Sanitizing Alcohol Wipes - Eucalyptus ChillALCOHOLBiom Innovations Inc23a89b5b-ee5f-4480-e063-6394a90a03b42026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc5a8186f8-2f47-e57c-e063-6394a90a723a2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Aloe YouALCOHOLChurch & Dwight Co., Inc.5a83e963-6a61-fa59-e063-6394a90ade6c2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5a83fc8f-31db-fd2a-e063-6294a90a8c432026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Blue SandalwoodALCOHOLChurch & Dwight Co., Inc.5a840981-765b-07f1-e063-6294a90ac6a32026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Citrus GroveALCOHOLChurch & Dwight Co., Inc.5a84344b-4ddb-32e5-e063-6394a90a628b2026-09-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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