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
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
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 - Direct_RxDirect_Rx2026-04-17HUMAN 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 90 of 287 · 5,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care tokidoki Mermicorno SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.529d13e4-f6b7-4c7a-bb62-094f845b94282026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.062fc0fd-a501-411c-baff-0ad4c23cae3e2026-01-13WarningsExact identifier
unii: 3K9958V90M
Smart Care LEMON LIME HAND SANITIZERETHYL ALCOHOLAshtel Studios, Ince503895d-7b23-4865-90b3-5348faffd45c2026-01-13WarningsExact identifier
unii: 3K9958V90M
CELECOXIBCELECOXIBNIVAGEN PHARMACEUTICALS, INC.ae7943ab-b1fc-f08f-e053-2995a90a051e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
unii: ND2M416302
Instant Hand SanitizerALCOHOLHydrox Laboratoriesa818def4-f6e9-4a97-aa26-b7c082ae8d182026-01-12WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHydrox Laboratories285505b0-ee49-4d01-9019-1052e2fb19642026-01-12WarningsExact identifier
unii: 3K9958V90M
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
unii: ND2M416302
Instant Hand Sanitizer UnscentedALCOHOLHydrox Laboratoriescd42da2c-0235-4410-945b-baabb5c7931b2026-01-12WarningsExact identifier
unii: 3K9958V90M
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
unii: ND2M416302
Instant Hand SanitizerALCOHOLLTC Products Inc.6c16aeec-bef2-41f1-b22d-ac37c36255622026-01-12WarningsExact identifier
unii: 3K9958V90M
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDiscount Drug Mart37a6c0fb-e9c4-4a95-9539-ca5766b3a7012026-01-12WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLDiscount Drug Mart7ac6b062-b471-4653-9d6f-de2ca8f8b0142026-01-12WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.88e6418c-ceb3-4bd6-8765-b476d8bf3ff32026-01-12WarningsExact identifier
unii: ND2M416302
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d20b230-2cce-4d90-e053-2995a90a4c032026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sheer SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratoriesc20fce25-8120-fe5d-e053-2a95a90a53a02026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesbaed8202-21fd-3a43-e053-2a95a90ada322026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sensitive Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratories88dbd396-8955-271e-e053-2995a90a0a7a2026-01-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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