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 7 of 287 · 5,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOef6fa913-b65d-4b3a-b88a-89cdbbf740492026-08-21WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOee59fcad-e88b-4fc0-b71c-724881400a792026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer strawberry matcha scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO42fdd67d-e77c-4d08-9676-f37ec43f7e432026-08-21WarningsExact identifier
unii: 3K9958V90M
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
unii: 3K9958V90M
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210071
ndc (package): 83301-0012-3
ndc (package): 83301-0012-2
ndc (package): 83301-0011-2
ndc (package): 83301-0011-1
ndc (package): 83301-0028-1
ndc (package): 83301-0011-3
ndc (package): 83301-0012-1
ndc (product): 83301-0011
ndc (product): 83301-0028
ndc (product): 83301-0012
ndc11 (package): 83301001101
rxcui: 686379
rxcui: 205323
rxcui: 205322
spl id: 596c7695-b38d-0d40-e063-6394a90ac40f
spl set id: 643e177f-216d-4dfa-824a-7516a488304e
unii: JCX84Q7J1L
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
unii: ND2M416302
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
HDXETHYL ALCOHOLApollo Health and Beauty Caredf0063b2-2e30-428e-b5cf-24e566c388c22026-08-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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