FDA.reportPublic FDA data

NDC 68462-017 - Inflammation Reduction Pack

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
68462-017
Package NDCs from labels
68462-017-60
Manufacturer
TMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals Limited
Effective date
2015-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Emla Cream - TMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals LimitedTMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals Limited2015-11-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-017INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4Unmatched20151119_f7f3dcf8-8628-467f-b195-d2dd7e11ae93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
LIDOCAINEACTIVE INGREDIENT98PI200987INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
PRILOCAINEACTIVE INGREDIENT046O35D44RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
DICLOFENACACTIVE MOIETY144O8QL0L1INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
LIDOCAINEACTIVE MOIETY98PI200987INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
PRILOCAINEACTIVE MOIETY046O35D44RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
RANITIDINEACTIVE MOIETY884KT10YB7INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
PEG-55 HYDROGENATED CASTOR OILINACTIVE INGREDIENT0WZF1506N9INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]4

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 132 of 211 · 4,219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Diclofenac SodiumDICLOFENAC SODIUMActavis Pharma, Inc.74169b2d-ac56-4757-86c4-cdcfcd5f4eb52025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUMCoupler LLC2ce0741a-7bc7-8aec-e063-6294a90ae9ef2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackd6671b66-00ad-4949-b51a-36e1130b1cb52025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack49013aad-475c-4efb-84c6-15a5d4664fbf2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
unii: 98PI200987
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.762b7ef4-166c-43b8-9acd-2b9e7fa0bf362025-01-28WarningsExact identifier
unii: QTG126297Q
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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