NDC 68071-097 - Active-Medicated specimen collection kit

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
68071-097
Package NDCs from labels
68071-097-01
Manufacturer
Pharmaceutica North America, Inc | NuCare Pharmaceuticals | Professional Disposable International, Inc
Effective date
2014-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Active-Medicated Specimen Collection KitPharmaceutica North America, Inc | NuCare Pharmaceuticals | Professional Disposable International, Inc2014-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
FUROSEMIDEACTIVE INGREDIENT7LXU5N7ZO5ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
FUROSEMIDEACTIVE MOIETY7LXU5N7ZO5ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11
waterINACTIVE INGREDIENT059QF0KO0RACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]11

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 72 of 73 · 1,453 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
unii: F5UM2KM3W7
FUROSEMIDEFUROSEMIDEHF Acquisition Co LLC, DBA HealthFirstc5d9b063-e3fe-ec2f-e053-2995a90ab3f22021-06-28Warnings, Adverse reactionsExact identifier
unii: 7LXU5N7ZO5
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FurosemideFUROSEMIDEProficient Rx LPce84359c-2f76-421a-9b2b-79b1c2be2f202021-01-01Warnings, Adverse reactionsExact identifier
unii: 7LXU5N7ZO5
Life is Simple Hand SanitizerNON-ALCOHOL FOAMING HAND SANITIZERApollo Health and Beauty Care0c5fad07-a91a-4d5f-8554-0d2f3a13ab132020-10-06WarningsExact identifier
unii: F5UM2KM3W7
FurosemideFUROSEMIDEGland Pharma Limited644704c0-e6a5-4804-bfa6-795c8f83aa7a2020-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7LXU5N7ZO5
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPAP Mask cleaning wipesBENZETHONIUM CHLORIDE AND BENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.412e6fec-5af5-45f7-8c6b-393b884e161c2019-06-07WarningsExact identifier
unii: F5UM2KM3W7
BZK ToweletteBENZALKONIUM CHLORIDEAcme United Corporation866fdc1e-19b2-4d79-e053-2a91aa0a36fe2019-04-16WarningsExact identifier
unii: F5UM2KM3W7
Callington Anti-Bacterial Hand SanitiserBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.1c6650c9-29fa-4fba-8442-fe294a2087c02019-02-25WarningsExact identifier
unii: F5UM2KM3W7
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Harris Teeter Spring Fresh Body WashBENZALKONIUM CHLORIDEHarris Teeter401106d1-a701-48bf-b8fc-1bc0454c41392018-07-26WarningsExact identifier
unii: F5UM2KM3W7
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: F5UM2KM3W7
FurosemideFUROSEMIDEAphena Pharma Solutions - Tennessee, LLC1d2733ac-6fa6-44d1-96d4-f1a698045ad22018-04-18Warnings, Adverse reactionsExact identifier
unii: 7LXU5N7ZO5
Soft Care SentryBENZALKONIUM CHLORIDEDiversey, Inc.f0686b7b-2f41-4656-8eb2-09483571a1bc2018-03-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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