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 8 of 215 · 4,283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
unii: 92RU3N3Y1O
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
unii: R16CO5Y76E
Aspirin 81mg Enteric CoatedASPIRINCardinal Health 107, LLC277723db-3578-4842-92eb-2de325f876492026-07-28WarningsExact identifier
unii: R16CO5Y76E
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
unii: R16CO5Y76E
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mgASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLEPar Health USA, LLC237a1f63-53ff-47fa-903c-ac6276e594a22026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 259081
unii: R16CO5Y76E
unii: 64ALC7F90C
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
unii: 92RU3N3Y1O
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
unii: 92RU3N3Y1O
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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