FDA.reportPublic FDA data

NDC 83301-0011-01 - 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
83301-0011
Requested NDC
83301-0011-01
Package NDCs from labels
83301-0011-1, 83301-0011-2, 83301-0011-3, 83301-0011-01
Manufacturer
Direct_Rx
Effective date
2026-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Celecoxib - Direct_RxDirect_Rx2026-10-30HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.2026-08-19HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - A-S Medication SolutionsA-S Medication Solutions2026-08-07HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - Preferred Pharmaceutical Inc.Preferred Pharmaceutical Inc.2026-03-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0011-1Celecoxib100 in 1 BOTTLECAPSULE1003
83301-0011-2Celecoxib500 in 1 BOTTLECAPSULE5003
83301-0011-3Celecoxib30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0011CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.]2Current NDC, 3 package rows20250425_643e177f-216d-4dfa-824a-7516a488304e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0011-1EA - Each83301-0011f892d2c0-443b-4ef6-bff5-4c32e3f1dfe412025-03-04
83301-0011-2EA - Each83301-0011d8085f29-1314-4207-8471-f4b25fe1253d12025-03-04

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 192 of 280 · 5,582 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
unii: 15FIX9V2JP
CelecoxibCELECOXIBEPIC PHARMA, LLCac670924-0a3f-4f94-ac01-9e3c3071c9902025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
Gel Antiseptico DermowipeGEL ANTISEPTICO A BASE DE ALCOHOL ETILICOKey Qumica S.A. de C.V.15620afc-d6ae-0f34-e063-6294a90a8ad22025-01-07WarningsExact identifier
unii: 3K9958V90M
Sipa hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbad83b-b8aa-a780-e053-6294a90a58ab2025-01-07WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Gingerbread BakeryALCOHOLBath & Body Works, Inc.2b0f53e3-eb4c-a372-e063-6394a90ae5df2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.2b0f4ddc-2384-3841-e063-6394a90aa2952025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Deep OceanALCOHOLBath & Body Works, Inc.2b0f3f65-746c-44ea-e063-6294a90a91852025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Sparkling SpritzALCOHOLBath & Body Works, Inc.2b0f3ca1-0a65-08a6-e063-6294a90a9df22025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Paris AmourALCOHOLBath & Body Works, Inc.2b0f525b-ff65-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh BalsamALCOHOLBath & Body Works, Inc.2b0f3ca1-0a64-08a6-e063-6294a90a9df22025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Perfect in PinkALCOHOLBath & Body Works, Inc.2b0f4b8f-b046-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.2b0f4b8f-b041-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowy Peach BerryALCOHOLBath & Body Works, Inc.2b0f466b-8e08-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne In ParisALCOHOLBath & Body Works, Inc.2b0f525b-ff63-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender LuxeALCOHOLBath & Body Works, Inc.2b0f466b-8e0c-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Cookie Butter TruffleALCOHOLBath & Body Works, Inc.2b0f525b-ff60-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bright Christmas MorningALCOHOLBath & Body Works, Inc.2b0f4b8f-b042-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla IciclesALCOHOLBath & Body Works, Inc.2b0f3f65-746f-44ea-e063-6294a90a91852025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Bubbly RoseALCOHOLBath & Body Works, Inc.2b1164fb-f6d5-5962-e063-6294a90a72972025-01-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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