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 7 of 215 · 4,283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
unii: R16CO5Y76E
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
unii: R16CO5Y76E
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
unii: R16CO5Y76E
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Migraine ReliefACETAMINOPHEN, ASPIRIN AND CAFFEINEHARRIS TEETERff32572c-393b-0b49-e053-6394a90a83da2026-08-05WarningsExact identifier
unii: R16CO5Y76E
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
unii: R16CO5Y76E
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
unii: R16CO5Y76E
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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