FDA.reportPublic FDA data

NDC 70518-0627-01 - Diclofenac Sodium Delayed Release

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
70518-0627
Requested NDC
70518-0627-01
Package NDCs from labels
70518-0627-0, 70518-0627-1, 70518-0627-2, 70518-0627-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac SodiumREMEDYREPACK INC.2026-06-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0627-0Diclofenac SodiumDelayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3017
70518-0627-1Diclofenac SodiumDelayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9017
70518-0627-2Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0627DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250429_10991fe6-fafd-49af-9684-83b447c19c67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0627-1EA - Each70518-0627d49b11d1-04f7-43dc-a27f-7f16fa99195712026-01-08
70518-0627-2EA - Each70518-0627c1c66442-ad39-4065-9d70-5a490125f03012026-01-08

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 58 of 121 · 2,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
unii: 15FIX9V2JP
BRING GREEN TEA TREE CICA SUN CUSHIONZINC OXIDE, TITANIUM DIOXIDECJ Olive Young Corporation30850a56-6438-dbe1-e063-6294a90a6d9f2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
unii: 15FIX9V2JP
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMH E B027803c5-85ae-4b86-8bd4-e61f8f34d0362025-11-17WarningsExact identifier
unii: QTG126297Q
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMMeijer, Inc.5cc570c6-2585-4d1a-9352-b1161458af9a2025-11-17WarningsExact identifier
unii: QTG126297Q
Huey Daily MineralTITANIUM DIOXIDE, ZINC OXIDEHuey15bdf9c6-3bfa-4eef-e063-6294a90a195f2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
unii: 15FIX9V2JP
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMPHOENIX RX LLC41472cca-278b-934b-e063-6294a90aaf5d2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC4382cc15-8978-4f3b-e063-6394a90a9ecb2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
unii: 15FIX9V2JP
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac Sodium Topical 1%DICLOFENAC SODIUMYYBA CORP043df5d2-6f3e-311f-e063-6294a90a23d72025-11-10WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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