FDA.reportPublic FDA data

NDC 80425-0403-01 - Diclofenac Epolamine

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
80425-0403
Requested NDC
80425-0403-01
Package NDCs from labels
80425-0403-1, 80425-0403-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Epolamine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-06-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0403-1Diclofenac Epolamine6 in 1 CARTONSYSTEM61
80425-0403-1Diclofenac Epolamine5 in 1 POUCHSYSTEM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0403DICLOFENAC EPOLAMINE SYSTEM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240622_1b563e42-3b06-5320-e063-6294a90a30e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0403-1EA - Each80425-040309e1982f-0de8-4234-91ff-1ddd54546f6f12024-08-12

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 24 of 121 · 2,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
unii: 15FIX9V2JP
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Lawn and Garden Detox 6026LAWN AND GARDEN DETOXProfessional Complementary Health Formulas2db4bdd8-1049-450a-8642-0e1dbbe5abb32026-01-08WarningsExact identifier
unii: 15FIX9V2JP
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
unii: 15FIX9V2JP
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
unii: K679OBS311
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
unii: K679OBS311
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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