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 1 of 339 · 6,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932026-09-11Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
unii: 98PI200987
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
unii: 98PI200987
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
unii: 98PI200987
GabapentinGABAPENTINREMEDYREPACK INC.167d8b87-506c-4293-9579-563feaa715832026-09-10Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHenry Schein, Inc.23c8f711-e458-479a-9ab0-dcc851311e242026-09-10Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
GabapentinGABAPENTINClinical Solutions Wholesale, LLCb7f9a106-52c6-49e4-acf5-8fb07761ba4f2026-09-09Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
unii: 98PI200987
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9a9fc7c-31da-ea3f-e053-2a95a90a0eab2026-09-09WarningsExact identifier
unii: V13007Z41A
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
unii: V13007Z41A
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
unii: 98PI200987

Reported adverse events (FAERS/openFDA)#

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