FDA.reportPublic FDA data

NDC 0132-0544 - Fleet

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
0132-0544
Package NDCs from labels
0132-0544-40
Manufacturer
C.B. Fleet Company, Inc.
Effective date
2021-04-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fleet Enema, Adult, China 0132-0544-40C.B. Fleet Company, Inc.2021-04-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0132-0544-402021-04-27C16284748780-19d75b9d0-fea4-f424-e053-dadaa90a57ceFleet Enema, Adult, China 0132-0544-40
0132-0544-402020-01-31C16284748780-19d75b9d0-fea4-f424-e053-dadaa90a57ceFleet Enema, Adult, China 0132-0544-40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0544-40Fleet133 mL in 1 BOTTLE, WITH APPLICATORENEMA1332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0544FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]21 package rows20210428_3a2cee3f-9596-4ee8-809a-31a321527e99.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4BFLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]1
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWFLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744FLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFLEET (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC) ENEMA [C.B. FLEET COMPANY, INC.]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 20 of 22 · 439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron12e87e30-7c60-11e6-869d-424c583030312023-02-20Exact identifier
unii: 70WT22SF4B
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
ZylastXP Antiseptic FoamingBENZETHONIUM CHLORIDEInnovative Biodefense86857d95-56ce-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
unii: PH41D05744
Nat PhosSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEHyland's Inc.d3ac00f2-590b-7185-e053-2a95a90a3f4a2022-12-13WarningsExact identifier
unii: 70WT22SF4B
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.f48a35d4-aa0c-48b1-a2ad-a614ea2894e82022-12-07WarningsExact identifier
unii: 70WT22SF4B
Natrum PhosphoricumNATRUM PHOSPHORICUMHahnemann Laboratories, INC.ed01509a-afb6-476f-e053-2995a90a5aa62022-11-08Exact identifier
unii: 70WT22SF4B
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Dr Talbots Infgant Gas Colic ReliefCARBO VEGETABILIS 12X,CHAMOMILLA 12X,FOENICULUM VULGARE 12X,LYCOPODIUM 30X,NUX MOSCHATA 12X,RAPHANUS SATIVUS 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bee190-04b2-4be6-e053-2a95a90a30a02022-09-28WarningsExact identifier
unii: 70WT22SF4B
Dr Talbots Infant Tummy Ache ReliefCALENDULA OFFICINALIS 12X,CARBO VEGETABILIS 12X,LYCOPODIUM 30X,FOENICULUM VULGARE 12X,NUX MOSCHATA 12X,ZINGIBER OFFICINALE 12X,KALI MURIATICUM 6X,MAGNESIA PHOSPHORICA 12X,NATRUM PHOSPHORICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e9c24994-b935-36e6-e053-2a95a90a78df2022-09-28WarningsExact identifier
unii: 70WT22SF4B
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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