FDA.reportPublic FDA data

NDC 0169-3003-01 - Novolin R

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
0169-3003
Requested NDC
0169-3003-01
Package NDCs from labels
0169-3003-01, 0169-3003-15, 0169-3003-12, 0169-3003-25
Manufacturer
Novo Nordisk
Effective date
2022-11-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Novolin R - Novo NordiskNovo Nordisk2022-11-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3003-01NovolinR3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION319
0169-3003-12NovolinR3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION319
0169-3003-15NovolinR5 in 1 CARTONINJECTION, SOLUTION519
0169-3003-25NovolinR5 in 1 CARTONINJECTION, SOLUTION519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3003NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]19Current NDC, Legacy NDC, 4 package rows20221208_aee7f1f3-612c-4027-8ce9-4fd1f41eed71.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3003-01ML - Milliliter0169-3003476b3f63-aa36-4fed-9ed4-21549f6e3b1012021-04-08
0169-3003-12ML - Milliliter0169-30034b0b8f92-b40a-4627-9199-59fd02f0cf9812022-06-06
0169-3003-15ML - Milliliter0169-300395639287-ef66-4d48-9d5f-cb16b204833a12020-01-03
0169-3003-25ML - Milliliter0169-3003653bc94f-b955-47ac-830e-17376b76664012020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12

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 17 of 37 · 727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: J41CSQ7QDS
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: J41CSQ7QDS
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: J41CSQ7QDS
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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