FDA.reportPublic FDA data

NDC 0517-0031-01 - CYANOCOBALAMIN

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
0517-0031
Requested NDC
0517-0031-01
Package NDCs from labels
0517-0031-01, 0517-0031-25
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYANOCOBALAMIN - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-04-10HUMAN PRESCRIPTION DRUG LABEL
CYANOCOBALAMIN INJECTION, USPAmerican Regent, Inc.2023-10-31HUMAN PRESCRIPTION DRUG LABEL
B-12 Compliance Injection KitRX PHARMA-PACK, INC.2020-10-22HUMAN PRESCRIPTION DRUG LABEL
Cyanocobalamin - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0031-01Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION112
0517-0031-25Cyanocobalamin25 in 1 TRAYINJECTION, SOLUTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0031CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]12Current NDC, Legacy NDC, 2 package rows20231101_2fb653d6-e2b2-4969-831b-c0dc37b9c0cc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0031-01ML - Milliliter0517-003163a936e0-d7e0-4346-b5c7-50ddd17e550812019-04-11
0517-0031-25ML - Milliliter0517-0031e8df80b8-81e5-4fc5-8235-ff942480e1a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204B-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302B-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204B-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302B-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHB-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBB-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XB-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IB-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RB-12 COMPLIANCE (CYANOCOBALAMIN, ISOPROPYL ALCOHOL) KIT [RX PHARMA-PACK, INC.]4
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, 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 4 of 186 · 3,705 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
application number: M003
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact identifier
application number: M003
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Povidone Iodine SwabstickPOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLC59f82f9d-8c39-6890-e063-6294a90a090e2026-08-26WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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