FDA.reportPublic FDA data

NDC 63323-012-06 - Oxytocin

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
63323-012
Requested NDC
63323-012-06
Package NDCs from labels
63323-012-06, 63323-012-10, 63323-012-02, 63323-012-30, 63323-012-03, 63323-012-11, 63323-012-17, 63323-012-07
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-10-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxytocin - Cardinal Health 107, LLCCardinal Health 107, LLC2026-10-12HUMAN PRESCRIPTION DRUG LABEL
Oxytocin Injection, USPREMEDYREPACK INC.2026-09-01HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-12HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-15HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
Oxytocin - Cardinal HealthCardinal Health2020-06-04HUMAN PRESCRIPTION DRUG LABEL
Oxytocin - Cardinal HealthCardinal Health2019-09-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-012-07Oxytocin25 in 1 TRAYINJECTION, SOLUTION259
63323-012-17Oxytocin1 mL in 1 VIALINJECTION, SOLUTION19
63323-012-02Oxytocin30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION307
63323-012-03Oxytocin1 mL in 1 VIALINJECTION, SOLUTION17
63323-012-06Oxytocin10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107
63323-012-10Oxytocin25 in 1 TRAYINJECTION, SOLUTION257
63323-012-11Oxytocin25 in 1 TRAYINJECTION, SOLUTION257
63323-012-30Oxytocin10 in 1 TRAYINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-012OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20241127_6d7d1280-f286-4f39-89f3-2b96571810e6.zip
63323-012OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 6 package rows20231026_c7fd585a-99b7-4309-b003-a6cbef05372c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-012-01ML - Milliliter63323-012052a8ba6-aa27-434e-8251-41c918d1650712013-02-13
63323-012-02ML - Milliliter63323-0126b888f76-9da2-48e1-a975-b225062226fa12021-05-05
63323-012-03ML - Milliliter63323-0123a2c557d-20bf-4a78-881b-1588d61b628812020-01-03
63323-012-06ML - Milliliter63323-0127862b5a3-ef73-44b3-a89e-493ccc6e5c2312019-09-05
63323-012-07ML - Milliliter63323-012f5a5734c-514a-4f23-9a52-9383dc446e7912020-02-13
63323-012-10ML - Milliliter63323-01283be660b-7e9f-4b18-84a9-b898e408f75212013-02-13
63323-012-11ML - Milliliter63323-012eafdb176-6892-4ff5-9ed0-0362316426ab12020-01-03
63323-012-12ML - Milliliter63323-01262b78a3c-8843-45ab-992d-09cf4756c58812013-02-13
63323-012-17ML - Milliliter63323-0122a7d0a2c-f726-4202-999b-2e123de8432a12020-02-13
63323-012-30ML - Milliliter63323-012f3bdbfc9-4587-43c5-a86e-e12fc1102b7612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
OXYTOCINACTIVE INGREDIENT1JQS135EYNOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
OXYTOCINACTIVE MOIETY1JQS135EYNOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063POXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCOXYTOCIN INJECTION, SOLUTION [CARDINAL HEALTH]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 741 · 14,817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
unii: F5UM2KM3W7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
unii: F5UM2KM3W7
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
application number: M003
unii: 3K9958V90M
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
SurviveX PREP WIPESALCOHOL PREP PADChangzhou Maokang Medical Products Co., Ltd.5a7e9dc6-cf43-7ffc-e063-6394a90a3faa2026-09-04WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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