FDA.reportPublic FDA data

NDC 55553-462 - ACS25Q35F SPINAL

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
55553-462
Package NDCs from labels
55553-462-02
Manufacturer
Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2012-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IODINE - Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.Clint Pharmaceuticals, Inc. | Smiths Medical ASD, Inc. | Aplicare, Inc.2012-06-27MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-0001-3ACS25Q35F SPINAL22.5 mL in 1 PACKETSOLUTION22.5 mL0.10 mg in 1mL4
55553-462-02ACS25Q35F SPINAL1 in 1 PACKAGE, COMBINATIONKIT14
55553-462-02ACS25Q35F SPINAL30 in 1 CASEKIT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55553-462ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]43 package rows20120716_98d482f0-070a-42d3-af48-0c189d4b2f8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
IODINEACTIVE MOIETY9679TC07X4ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RACS25Q35F SPINAL () KIT [CLINT PHARMACEUTICALS, 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 13 of 25 · 481 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
unii: GR686LBA74
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
POVIDONE-IODINE PREP PADS MEDIUMPOVIDONE-IODINE PREP PADS MEDIUMHF Acquisition Co. LLC, DBA HealthFirst33f08f03-93fb-214d-e063-6394a90a73bd2025-04-29WarningsExact identifier
unii: 85H0HZU99M
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
unii: 85H0HZU99M
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
unii: 85H0HZU99M
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
TM TITUS MEDICAL ANTISEPTIC Non SterilePOVIDONE-IODINETitus Medical LLC690b87d0-d889-43c6-b99e-cd9f26fd682a2025-01-17WarningsExact identifier
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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