FDA.reportPublic FDA data

NDC 0591-2070-01 - Aprizio Pak

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
0591-2070
Requested NDC
0591-2070-01
Package NDCs from labels
0591-2070-30, 0591-2070-72, 0591-2070-26, 0591-2070-01
Manufacturer
PureTek Corporation
Effective date
2024-01-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aprizio Pak - PureTek CorporationPureTek Corporation2024-01-12HUMAN PRESCRIPTION DRUG LABEL
Cyclopak - PureTek CorporationPureTek Corporation2024-01-12HUMAN PRESCRIPTION DRUG LABEL
Prilo Patch - PureTek CorporationPureTek Corporation2024-01-12HUMAN PRESCRIPTION DRUG LABEL
Prilo Patch-II - PureTek CorporationPureTek Corporation2021-10-08HUMAN PRESCRIPTION DRUG LABEL
Nuvakaan - PureTek CorporationPureTek Corporation2021-03-30HUMAN PRESCRIPTION DRUG LABEL
DermacinRx Prizopak - PureTek CorporationPureTek Corporation2021-03-30HUMAN PRESCRIPTION DRUG LABEL
DermacinRx Empricaine - PureTek CorporationPureTek Corporation2021-03-30HUMAN PRESCRIPTION DRUG LABEL
Lidocaine and Prilocaine - Proficient Rx LPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL
Prizotral - PureTek CorporationPureTek Corporation2020-11-17HUMAN PRESCRIPTION DRUG LABEL
ACT Kit™ (Accelerated COVID-19 Antibody Test Kit)Asclemed USA, Inc.2020-09-22HUMAN PRESCRIPTION DRUG LABEL
ACT Kit™ (Accelerated COVID-19 Antibody Test Kit)Asclemed USA, Inc.2020-09-22HUMAN PRESCRIPTION DRUG LABEL
Lipritin - PureTek CorporationPureTek Corporation2020-02-29HUMAN PRESCRIPTION DRUG LABEL
Prilopentin - PureTek CorporationPureTek Corporation2019-08-19HUMAN PRESCRIPTION DRUG LABEL
Lidocaine 2.5% and Prilocaine 2.5% Cream, USPActavis Pharma, Inc.2019-07-31HUMAN PRESCRIPTION DRUG LABEL
Lidocaine 2.5% and Prilocaine 2.5% Cream, USPNuCare Pharmaceuticals,Inc.2018-11-29HUMAN PRESCRIPTION DRUG LABEL
lidocaine and prilocaine cream - Sircle Laboratories LLCSircle Laboratories LLC2018-02-13HUMAN PRESCRIPTION DRUG LABEL
Anodyne LPT - Fortus Pharma, LLCFortus Pharma, LLC2017-03-17HUMAN PRESCRIPTION DRUG LABEL
Lido-Prilo Caine Pack - TMIG Inc. | EPM Packaging, Inc.TMIG Inc. | EPM Packaging, Inc.2017-01-09HUMAN PRESCRIPTION DRUG LABEL
DermacinRx Prikaan - Shoreline Pharmaceuticals, Inc.Shoreline Pharmaceuticals, Inc.2016-09-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2070-30Lido-Prilo Caine Pack1 in 1 CARTONCREAM25 mg in 1g3
0591-2070-30Lido-Prilo Caine Pack30 g in 1 TUBECREAM90 g25 mg in 1g3
0591-2070-30DermacinRx Prikaan1 in 1 CARTONCREAM25 mg in 1g2
0591-2070-30DermacinRx Prikaan30 g in 1 TUBECREAM90 g25 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2070LIDO-PRILO CAINE PACK (LIDOCAINE AND PRILOCAINE) KIT [TMIG INC.]3Legacy NDC20170109_47ce5ac7-0ee2-48c3-a310-151b5b386a6c.zip
0591-2070DERMACINRX PRIKAAN (LIDOCAINE AND PRILOCAINE) KIT [SHORELINE PHARMACEUTICALS, INC.]2Legacy NDC20160920_ded2a2fc-e74c-43a5-9bf1-4b11f68a5254.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2070-26GM - Gram0591-2070bb51e17f-846d-442a-b728-c199f1f9fd4712016-10-06
0591-2070-30GM - Gram0591-20700f2d823c-99da-4b40-ae99-9a2f22e4a16512015-05-05
0591-2070-72GM - Gram0591-2070349eee15-efab-4789-b861-5e303e8f8d7812015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
PEG-55 HYDROGENATED CASTOR OILINACTIVE INGREDIENT0WZF1506N9LIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [ACTAVIS PHARMA, INC.]2
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
PRILOCAINEACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
PRILOCAINEACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
PEG-55 HYDROGENATED CASTOR OILINACTIVE INGREDIENT0WZF1506N9LIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [PROFICIENT RX LP]1

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 5 of 335 · 6,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
unii: ND2M416302
GABAPENTINGABAPENTINPHOENIX RX LLC5a85ea98-4211-54eb-e063-6294a90aff332026-09-02Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9920daef-b156-4a14-b641-f714191ffb5c2026-09-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
unii: 98PI200987
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.30e61110-5bc8-4134-8456-5385584797352026-09-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2026-09-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
unii: 98PI200987
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
unii: 98PI200987
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
LIDOCAINELIDOCAINEREMEDYREPACK INC.dfef4554-aeb4-4bdf-9557-648d3e84af3c2026-08-31Warnings, Adverse reactionsExact identifier
unii: 98PI200987
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.ba659e1a-0091-45f6-b418-f4f36c9a2c792026-08-31Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
unii: 98PI200987
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
unii: 98PI200987
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
unii: 98PI200987
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
unii: 98PI200987
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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