FDA.reportPublic FDA data

NDC 00597-001 - Aggrenox

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
00597-001
Manufacturer
Rebel Distributors Corp.
Effective date
2010-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aggrenox - Rebel Distributors Corp.Rebel Distributors Corp.2010-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dipyridamoleACTIVE INGREDIENT64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
aspirinACTIVE MOIETYR16CO5Y76EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dipyridamoleACTIVE MOIETY64ALC7F90CAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
acaciaINACTIVE INGREDIENT5C5403N26OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
aluminum stearateINACTIVE INGREDIENTU6XF9NP8HMAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
gelatinINACTIVE INGREDIENT2G86QN327LAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
hypromellose phthalate (31% phthalate, 170 cst)INACTIVE INGREDIENT8LDD2V82F5AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
methacrylic acid - methyl methacrylate copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94EAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
sucroseINACTIVE INGREDIENTC151H8M554AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
tartaric acidINACTIVE INGREDIENTW4888I119HAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
triacetinINACTIVE INGREDIENTXHX3C3X673AGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
waterINACTIVE INGREDIENT059QF0KO0RAGGRENOX (ASPIRIN AND DIPYRIDAMOLE) CAPSULE [REBEL DISTRIBUTORS CORP.]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 2 of 215 · 4,283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
butalbital, aspirin, and caffeineBUTALBITAL, ASPIRIN, AND CAFFEINEChartwell RX, LLCe69d8bb1-ba09-42e2-8372-7f5e0a9061742026-09-01Warnings, Adverse reactionsExact identifier
unii: R16CO5Y76E
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra Strength Gas ReliefSIMETHICONE ANTIGASKROGER COMPANY6aa691e4-3179-4cf7-855a-e44f16904c1c2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Infants Gas Relief Dye FreeSIMETHICONE ANTIGASTHE KROGER CO.722c8226-6556-4150-9fda-91be2b31183f2026-08-31WarningsExact identifier
unii: 92RU3N3Y1O
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
unii: R16CO5Y76E
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
unii: R16CO5Y76E
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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