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 8 of 33 · 642 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Complete Pain ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Company210efe01-3cf4-404c-84b0-314615467ace2026-01-20WarningsExact identifier
unii: 3G6A5W338E
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Menstrual Pain ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Company3916230c-39e5-4f64-aa0b-b090b000ec352026-01-20WarningsExact identifier
unii: 3G6A5W338E
Leader Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. dba Leaderb74a8baa-c7a2-4eed-8202-888d8ba829b92026-01-20WarningsExact identifier
unii: 3G6A5W338E
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWalgreen Companyfc258e1f-5447-421a-84a8-2d9e72fd60992026-01-20WarningsExact identifier
unii: 3G6A5W338E
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
unii: 3G6A5W338E
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
unii: 3G6A5W338E
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
unii: 3G6A5W338E
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATEBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEAmneal Pharmaceuticals of New York, LLC828e30fa-7bb1-486b-80ee-806fce45e4e42026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
unii: 3G6A5W338E
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATEActavis Pharma, Inc.a58819b8-a52c-44a7-9ab0-c74480d985062026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Caffeine Mix 1003CAFFEINE MIXProfessional Complementary Health Formulasce7f9a40-6cb1-49d1-a36a-e0f292dd136e2026-01-08WarningsExact identifier
unii: 3G6A5W338E
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
NorgesicORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLCbe2761bc-e537-4039-846a-2ffa3d8b2afc2026-01-08Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEAdvanced Rx of Tennessee, LLC4871c36f-229b-4c12-e063-6394a90a028e2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Caffeine 1508CAFFEINEProfessional Complementary Health Formulas970ce7be-a373-45db-b35f-f150a49d1fba2026-01-08WarningsExact identifier
unii: 3G6A5W338E

Reported adverse events (FAERS/openFDA)#

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