FDA.reportPublic FDA data

NDC 51072-039-01 - ORAL-PRO SODIUM SALICYLATE with Caffeine

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
51072-039
Requested NDC
51072-039-01
Package NDCs from labels
51072-039-01
Manufacturer
Aurora Pharmaceutical, Inc.
Effective date
2025-05-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORAL-PRO ® Sodium Salicylate Concentrate 60% w/v with Caffeine 5.7% w/vAurora Pharmaceutical, Inc.2025-05-29OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51072-039-01ORAL-PRO SODIUM SALICYLATEwith Caffeine3790 mL in 1 BOTTLESOLUTION379015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51072-039ORAL-PRO SODIUM SALICYLATE WITH CAFFEINE (SODIUM SALICYLATE) SOLUTION [AURORA PHARMACEUTICAL, INC.]141 package rows20230301_d11b86c2-3f94-46cd-8b4d-9a6405d50b76.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338EORAL-PRO SODIUM SALICYLATE CONCENTRATE WITH CAFFEINE (SODIUM SALICYLATE) SOLUTION [AURORA PHARMACEUTICAL LLC]6
SODIUM SALICYLATEACTIVE INGREDIENTWIQ1H85SYPORAL-PRO SODIUM SALICYLATE CONCENTRATE WITH CAFFEINE (SODIUM SALICYLATE) SOLUTION [AURORA PHARMACEUTICAL LLC]6
CAFFEINEACTIVE MOIETY3G6A5W338EORAL-PRO SODIUM SALICYLATE CONCENTRATE WITH CAFFEINE (SODIUM SALICYLATE) SOLUTION [AURORA PHARMACEUTICAL LLC]6
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZORAL-PRO SODIUM SALICYLATE CONCENTRATE WITH CAFFEINE (SODIUM SALICYLATE) SOLUTION [AURORA PHARMACEUTICAL LLC]6

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 1 of 24 · 462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
butalbital, aspirin, and caffeineBUTALBITAL, ASPIRIN, AND CAFFEINEChartwell RX, LLCe69d8bb1-ba09-42e2-8372-7f5e0a9061742026-09-01Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
unii: 3G6A5W338E
migraine reliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreen Company36503181-0fda-4127-b3f0-bdb1b56bb0ed2026-08-24WarningsExact identifier
unii: 3G6A5W338E
Stay AwakeCAFFEINEUnited Natural Foods, Inc. dba UNFI15e4d040-ed21-46e7-98c6-56267f388f572026-08-21WarningsExact identifier
unii: 3G6A5W338E
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
unii: 3G6A5W338E
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
unii: 3G6A5W338E
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
unii: 3G6A5W338E
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
unii: 3G6A5W338E
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: 3G6A5W338E
Nuvicare-Urinary Tract DefenseMETHENAMINE, SODIUM SALICYLATENUVICARE LLC2ea2717e-437e-4417-a09d-ea7be9d9707d2026-08-10WarningsExact identifier
unii: WIQ1H85SYP
Gencare-Urinary Tract DefenseMETHENAMINE, SODIUM SALICYLATEPIONEER LIFE SCIENCES, LLC42e443d9-83f8-4868-8c1b-34fe4dc0ed8c2026-08-10WarningsExact identifier
unii: WIQ1H85SYP
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
unii: 3G6A5W338E
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
unii: 3G6A5W338E
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEHARRIS TEETERff32572c-393b-0b49-e053-6394a90a83da2026-08-05WarningsExact identifier
unii: 3G6A5W338E
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEKroger Companye97383af-6fbe-4531-af6a-c9ea9153e4382026-08-03WarningsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEHAWAII REPACK, INC.ab882f60-394c-4d4f-95f4-6b9d6d6b31932026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINESun Pharmaceutical Industries, Inc.a68de112-f5af-49ba-a8a8-3adbaa7df36e2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackf6bd2076-869e-40de-94ce-6be43d50f6802026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack8a4cf981-37f7-4bc9-a9d7-b134a5fd08942026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E

Reported adverse events (FAERS/openFDA)#

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