FDA.reportPublic FDA data

NDC 85509-1237-06 - 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
85509-1237
Requested NDC
85509-1237-06
Package NDCs from labels
85509-1237-3, 85509-1237-6, 85509-1237-9, 85509-1237-1, 85509-1237-06
Manufacturer
PHOENIX RX LLC
Effective date
2025-08-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CELECOXIB - PHOENIX RX LLCPHOENIX RX LLC2025-08-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1237-1CELECOXIB120 in 1 BOTTLECAPSULE1202
85509-1237-3CELECOXIB30 in 1 BOTTLECAPSULE302
85509-1237-6CELECOXIB60 in 1 BOTTLECAPSULE602
85509-1237-9CELECOXIB90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1237-1EA - Each85509-1237f500da85-029b-4671-be10-46f27428585d12025-09-12
85509-1237-3EA - Each85509-1237d661fdef-264a-4bef-b32e-e37eb6ff3b6412025-09-12
85509-1237-6EA - Each85509-1237a22f33cc-44ad-456d-9ac0-a85dd4e0481212025-09-12
85509-1237-9EA - Each85509-12373e6cde98-a8a2-43d0-8ff0-37d7438d5a2812025-09-12

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 166 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
unii: 15FIX9V2JP
CELECOXIBCELECOXIBPHOENIX RX LLC3a669c28-fbc7-827c-e063-6394a90a08292025-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210628
ndc (package): 85509-1237-6
ndc (package): 85509-1237-3
ndc (package): 85509-1237-9
ndc (package): 85509-1237-1
ndc (product): 85509-1237
ndc11 (package): 85509123706
rxcui: 205322
spl id: 3b76876f-39e9-82e3-e063-6294a90afafe
spl set id: 3a669c28-fbc7-827c-e063-6394a90a0829
unii: JCX84Q7J1L
Smart Care OCEAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e0a97dca-c0d0-4914-b570-0ac169bd78022025-08-01WarningsExact identifier
unii: 3K9958V90M
VYSCOXACELECOXIBCarwin Pharmaceutical Associates, LLC5094d47e-f791-4190-9397-b7500143a74d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
unii: ND2M416302
EcolabALCOHOLEcolab Inc.f2f922f0-afd3-40e0-ba6d-6b75159db6402025-07-31WarningsExact identifier
unii: 3K9958V90M
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
WICKED HAND SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e9352-15c9-954a-e063-6294a90a7a672025-07-29WarningsExact identifier
unii: 3K9958V90M
WICKED HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e7e57-6472-6cca-e063-6294a90a63a62025-07-29WarningsExact identifier
unii: 3K9958V90M
MISTIFY HAND SANITIZER COCONUTALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0f1b10-ed25-0949-e063-6394a90a6a802025-07-29WarningsExact identifier
unii: 3K9958V90M
MISTIFY HAND SANITIZER MANGOALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0fd685-c807-75e4-e063-6394a90a3d652025-07-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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