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 10 of 37 · 727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Echinacea Combination 9222ECHINACEA COMBINATIONProfessional Complementary Health Formulas430cc9f6-5565-4345-ac5f-d948fb3b14bd2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Pineal Liquescence 3030PINEAL LIQUESCENCEProfessional Complementary Health Formulas3574f919-0b93-4bf5-9ee9-8fadda5668c32026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Stress Tonic 2998STRESS TONICProfessional Complementary Health Formulas1f53201a-427a-4342-b510-890c33b9c4c62026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: PDC6A3C0OX
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: J41CSQ7QDS
Immune SupportACONITUM NAPELLUS, ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, ASTRAGALUS MEMBRANACEUS, BAPTISIA TINCTORIA, BRYONIA (ALBA), CALENDULA OFFICINALIS, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINALIS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM, LACHESIS MUTUS, MERCURIUS CORROSIVUS, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SANGUINARIA CANADENSIS, SPLEEN (SUIS), SULPHUR, THUJA OCCIDENTALIS, THYMUS,Deseret Biologicals, Inc.8b5a4609-184d-4a43-823a-91024d9dc0c12026-01-02WarningsExact identifier
unii: J41CSQ7QDS
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
unii: PDC6A3C0OX
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
unii: PDC6A3C0OX
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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