FDA.reportPublic FDA data

NDC 0517-2502-01 - Caffeine and Sodium Benzoate

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
0517-2502
Requested NDC
0517-2502-01
Package NDCs from labels
0517-2502-01, 0517-2502-10
Manufacturer
American Regent, Inc.
Effective date
2019-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CAFFEINE AND SODIUM BENZOATE INJECTION, USPAmerican Regent, Inc.2019-12-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-2502-01Caffeine and Sodium Benzoate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION27
0517-2502-10Caffeine and Sodium Benzoate10 in 1 BOXINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-2502CAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]7Current NDC, Legacy NDC, 2 package rows20221228_b2c6b352-f837-4903-8e4c-fb0a2b20bb60.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-2502-01ML - Milliliter0517-2502d7f8e535-ca10-4ba1-a0b6-b855c1d9293612019-04-11
0517-2502-10ML - Milliliter0517-2502d29437c4-d880-4d96-8542-9b17a6fc2fc012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ECAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
CAFFEINEACTIVE MOIETY3G6A5W338ECAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFFEINE AND SODIUM BENZOATE INJECTION, SOLUTION [AMERICAN REGENT, 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 9 of 33 · 642 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack15a34df5-e48f-4570-9232-80e4093c46242026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
unii: 3G6A5W338E
Stay AwakeCAFFEINEARMY AND AIR FORCE EXCHANGE SERVICE44d60bfb-4320-4f5b-8a22-9a984805ddaf2026-01-06WarningsExact identifier
unii: 3G6A5W338E
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEHikma Pharmaceuticals USA Inc.6e0e8abc-512b-42f7-8323-434c589edecf2026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact identifier
unii: 3G6A5W338E
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
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINERedpharm Drug4727e806-102a-3a28-e063-6294a90ab6e92025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Norgesic ForteORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEPoly Pharmaceuticals, Inc.85a3b808-b476-f2f0-e053-2a91aa0af21f2025-12-30Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
unii: 3G6A5W338E
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
unii: 3G6A5W338E
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
unii: 3G6A5W338E
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
unii: 3G6A5W338E
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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