FDA.reportPublic FDA data

NDC 05912-017 - 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
05912-017
Package NDCs from labels
05912-017-60
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
05912-017-60Inflammation Reduction Pack60 g in 1 TUBECREAM60 g25 mg in 1g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
05912-017INFLAMMATION 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 166 of 211 · 4,219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%NuCare Pharmaceuticals,Inc.0326ea5b-3e1a-dee2-e063-6294a90a13b82024-07-09WarningsExact identifier
unii: QTG126297Q
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC81e964ff-6622-4054-bf01-6ed6eef6778f2024-07-06WarningsExact identifier
unii: QTG126297Q
Bunnies Bum Hemorrhoidal NumbingLIDOCAINEFloCal Distributors LLC1c809643-0cbe-568f-e063-6394a90a32102024-07-05WarningsExact identifier
unii: 98PI200987
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
unii: 98PI200987
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
unii: 98PI200987
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Lidocan VLIDOCAINE 5%PURETEK CORPORATION141fe2bd-b25a-eff8-e063-6294a90a2ae82024-07-03Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Lidocan IIILIDOCAINE 5%PURETEK CORPORATION07a258e4-4858-43b3-e063-6394a90a50842024-07-03Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP898558e7-17f8-40cd-9dfc-67ddd64a5a422024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac SodiumDICLOFENAC SODIUMKROGER COMPANY15e59aac-a642-91e4-e063-6294a90a11752024-06-28WarningsExact identifier
unii: QTG126297Q
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC1b561cc6-1d36-e259-e063-6294a90aacbd2024-06-27Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC1be247b8-dafd-ddf9-e063-6294a90aa9e12024-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
unii: 15FIX9V2JP
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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