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
Label	Manufacturer	Effective date	Type
Emla Cream - TMIG, Inc. \| Actavis Elisabeth LLC \| Actavis LLC \| Shasun Pharmaceuticals Limited	TMIG, Inc. \| Actavis Elisabeth LLC \| Actavis LLC \| Shasun Pharmaceuticals Limited	2015-11-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-017	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4	Unmatched	20151119_f7f3dcf8-8628-467f-b195-d2dd7e11ae93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
PRILOCAINE	ACTIVE INGREDIENT	046O35D44R	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
PRILOCAINE	ACTIVE MOIETY	046O35D44R	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
RANITIDINE	ACTIVE MOIETY	884KT10YB7	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
PEG-55 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	0WZF1506N9	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
POLYVINYL ACETATE PHTHALATE	INACTIVE INGREDIENT	58QVG85GW3	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	INFLAMMATION 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 186 of 210 · 4,195 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CV TOX	COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODE	BioActive Nutritional, Inc.	8ef2fb5c-1b24-46a1-8d21-a78ce0a34a87	2023-11-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
Oligo Bio Iodine	CHELIDONIUM MAJUS, IODIUM, LYCOPUS VIRGINICUS, GINKGO BILOBA, PINUS SYLVESTRIS, FUCUS VESICULOSUS, SPONGIA TOSTA, GERMANIUM SESQUIOXIDE, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CYSTEINUM, MANGANESE GLUCONATE, ALPHA-KETOGLUTARICUM ACIDUM, CALCAREA CARBONICA, FERRUM IODATUM, FUMARICUM ACIDUM, KALI IODATUM, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM,	BioActive Nutritional, Inc.	90e3028e-9e1e-4887-8b7c-f712bf67cd52	2023-11-07	Warnings	Exact identifier unii: 98PI200987
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	82d210bc-b7ca-4d74-be58-85f175a75058	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	NEWCO LLC	fa3c73a3-0dfb-4673-822a-45d946dee260	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	867a88df-9a18-447f-8301-2ec91566302e	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	bf766aab-a52d-41e8-a06a-f2e536d2219b	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
PROJECT REEF SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	6bcd470c-6994-4d28-8370-4cc9d68e1e78	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30	TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE	O'Skin Studio NY	d84cca38-b673-484e-aa25-df58d904d4d3	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
SECONDARY NUMB Lidocaine Phenylephrine Gel	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	LALANI Rx Consulting, Inc.	0f13f7b5-e3b1-451e-a6d6-e7e15bd04443	2023-11-06	Warnings	Exact identifier unii: 98PI200987
HEARTBURN RELIEF	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	CHAIN DRUG MARKETING ASSOCIATION	b4656a2f-a866-5f7a-e053-2995a90ac2c2	2023-11-06	Warnings	Exact identifier unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Chain Drug Marketing Association	9f410b3a-5579-4fae-84b1-5cd35563451e	2023-11-06	Warnings	Exact identifier unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE	Chain Drug Marketing Association	60de23d0-6e75-3b97-e053-2a91aa0aea5e	2023-11-06	Warnings	Exact identifier unii: 5QB0T2IUN0
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Aruba Aloe Balm NV	80461b6d-b1b7-4220-894d-8bd425909474	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Brazzers Anal Desensitizing	LIDOCAINE	Metro Media Ent	ceacd80c-0dd6-4e21-97da-56da877b1c90	2023-11-06	Warnings	Exact identifier unii: 98PI200987
Image Prevention Refiner Primer SPF50	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0e490f11-666c-420c-8c12-b45cd238ce47	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 01 Light	TITANIUM DIOXIDE	Farmasi US LLC	97c1da03-b79c-46a3-a9f0-7aeb94ed66da	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan	TITANIUM DIOXIDE	Farmasi US LLC	deee5784-c68b-4cd7-acbf-f64391a01bfc	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium	TITANIUM DIOXIDE	Farmasi US LLC	cef1a926-b7d4-47d6-957d-e3092e60970c	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 06 Deep	TITANIUM DIOXIDE	Farmasi US LLC	2f13a160-740f-4b09-8858-e438a9ba303e	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 05 Tan	TITANIUM DIOXIDE	Farmasi US LLC	3f494921-844e-4010-ab0c-144c8dce8aca	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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