FDA.reportPublic FDA data

NDC 00527-1704 - Amantadine HCl

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
00527-1704
Manufacturer
Rebel Distributors Corp.
Effective date
2010-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine HCl - Rebel Distributors Corp.Rebel Distributors Corp.2010-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FAMANTADINE HCL (AMANTADINE HYDROCHLORIDE) 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 75 of 121 · 2,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
AmantadineAMANTADINECoupler LLC303c5b9d-5761-9fcd-e063-6394a90a8a2b2025-03-13Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: PDC6A3C0OX
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: PDC6A3C0OX
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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