FDA.reportPublic FDA data

NDC 51672-1358-02 - Clofenax

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
51672-1358
Requested NDC
51672-1358-02
Package NDCs from labels
51672-1358-2, 51672-1358-4, 51672-1358-02
Manufacturer
PureTek Corporation | Sun Pharma Canada Inc.
Effective date
2026-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clofenax - PureTek Corporation | Sun Pharma Canada Inc.PureTek Corporation | Sun Pharma Canada Inc.2026-07-24HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-04-02HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - REMEDYREPACK INC.REMEDYREPACK INC.2026-03-30HUMAN PRESCRIPTION DRUG LABEL
DICLOFENAC SODIUM - DirectRxDirectRx2026-03-17HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-02-18HUMAN PRESCRIPTION DRUG LABEL
Lextol - PureTek CorporationPureTek Corporation2025-12-19HUMAN PRESCRIPTION DRUG LABEL
Diclogen - PureTek CorporationPureTek Corporation2025-12-18HUMAN PRESCRIPTION DRUG LABEL
Lixofen - PureTek CorporationPureTek Corporation2025-12-18HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-02-08HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - PureTek CorporationPureTek Corporation2024-10-25HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - A-S Medication SolutionsA-S Medication Solutions2023-10-03HUMAN PRESCRIPTION DRUG LABEL
Lextol - PureTek CorporationPureTek Corporation2023-08-23HUMAN PRESCRIPTION DRUG LABEL
Diclotrex - PureTek CorporationPureTek Corporation2023-05-04HUMAN PRESCRIPTION DRUG LABEL
NuDiclo SoluPak - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2023-02-08HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Quality Care Products, LLCQuality Care Products, LLC2022-09-23HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Proficient Rx LPProficient Rx LP2022-05-02HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Central Packaging | Central Packaging, LLCCentral Packaging | Central Packaging, LLC2021-02-24HUMAN PRESCRIPTION DRUG LABEL
ALCOHOL - St. Mary's Medical Park Pharmacy | St Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy | St Mary's Medical Park Pharmacy2020-11-19HUMAN PRESCRIPTION DRUG LABEL
Diclofenac Sodium - Medsource PharmaceuticalsMedsource Pharmaceuticals2020-11-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1358-2Diclofenac Sodium1 in 1 CARTONSOLUTION113
51672-1358-2Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION15013
51672-1358-4Diclofenac Sodium60 mL in 1 BOTTLE, DROPPERSOLUTION6013
51672-1358-4Diclofenac Sodium1 in 1 CARTONSOLUTION113
51672-1358-2Clofenax150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
51672-1358-2Clofenax1 in 1 CARTONSOLUTION16.05 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1358DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 package rows20220814_fae53d24-acf1-4250-888d-b8d965ffc3d3.zip
51672-1358CLOFENAX (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20230112_b60e6572-0624-40c5-e053-2995a90ade48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1358-2ML - Milliliter51672-13583cbc277c-c918-43ae-bce6-4cff117c87f912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
alcoholINACTIVE INGREDIENT3K9958V90MDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
dimethyl sulfoxideINACTIVE INGREDIENTYOW8V9698HDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
glycerinINACTIVE INGREDIENTPDC6A3C0OXDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
waterINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5

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 1 of 402 · 8,026 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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