FDA.reportPublic FDA data

NDC 68462-015 - 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
68462-015
Manufacturer
TMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals Limited
Effective date
2015-10-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Inflammation Reduction Pack - TMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals LimitedTMIG, Inc. | Actavis Elisabeth LLC | Actavis LLC | Shasun Pharmaceuticals Limited2015-10-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
LIDOCAINEACTIVE INGREDIENT98PI200987INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
PRILOCAINEACTIVE INGREDIENT046O35D44RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
DICLOFENACACTIVE MOIETY144O8QL0L1INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
LIDOCAINEACTIVE MOIETY98PI200987INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
PRILOCAINEACTIVE MOIETY046O35D44RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
RANITIDINEACTIVE MOIETY884KT10YB7INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
PEG-55 HYDROGENATED CASTOR OILINACTIVE INGREDIENT0WZF1506N9INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]3

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 115 of 211 · 4,219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 15FIX9V2JP
SILICA MARINASILICON DIOXIDEBoiron3aada26e-6a8e-f545-e063-6394a90a9f802025-07-24Exact identifier
unii: ETJ7Z6XBU4
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
unii: 15FIX9V2JP
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
unii: 98PI200987
LidocaineLIDOCAINEAdvanced Rx of Tennessee, LLC3a9a6630-e470-b794-e063-6394a90aaab52025-07-23Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: 98PI200987
HealthWise Flexible 4% Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3869cc18-5494-6142-e063-6394a90a75e52025-07-22WarningsExact identifier
unii: 98PI200987
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsExact identifier
unii: 98PI200987
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: 98PI200987
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3a4f7301-aa1c-9064-e063-6294a90a6eb42025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
LIDOCAINELIDOCAINEPHOENIX RX LLC3a63652c-92a1-612b-e063-6294a90a034a2025-07-21Warnings, Adverse reactionsExact identifier
unii: 98PI200987
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
unii: 15FIX9V2JP
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: 98PI200987
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPHOENIX RX LLC3a63e26f-27d7-9a25-e063-6294a90a55fe2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
unii: 98PI200987
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
unii: 98PI200987
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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