FDA.reportPublic FDA data

NDC 63459-0700 - AMRIX

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
63459-0700
Manufacturer
Rebel Distributors Corp.
Effective date
2010-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMRIX ® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)Rebel Distributors Corp.2010-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
CyclobenzaprineACTIVE MOIETY69O5WQQ5TIAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
diethyl phthalateINACTIVE INGREDIENTUF064M00AFAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
gelatinINACTIVE INGREDIENT2G86QN327LAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [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 104 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1TITANIUM DIOXIDEAmway Corp7494fe09-40e0-4152-9974-a6e8a4d7f4212023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1TITANIUM DIOXIDEAmway Corpcec51b88-a6b8-4b64-b3aa-830e712a3c8a2023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1TITANIUM DIOXIDEAmway Corp706e1504-fad7-44fa-9030-f5b948e3e79b2023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1TITANIUM DIOXIDEAmway Corpb785af89-1134-4fc6-8388-c47c52d153e02023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2TITANIUM DIOXIDEAmway Corpdb24e10a-6957-4ce7-8b03-572caacc647a2023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1TITANIUM DIOXIDEAmway Corpe7d8616d-3e79-4b5e-b05b-fbb506c0203d2023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1TITANIUM DIOXIDEAmway Corpff387c87-4ada-41c6-b62b-07a1432137702023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1TITANIUM DIOXIDEAmway Corp48c0bb8b-2f89-465e-9ae6-98690a2f877c2023-10-22WarningsExact identifier
unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp830a748f-bb14-47f6-ab6f-48d8bd7063212023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp20c432e2-4c63-485b-9dd5-2bc73b6f42852023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - LightENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAccess Business Group LLC070f9538-4b36-471a-aa06-6669e9ecfdf02023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp40a82d20-b84b-4ae8-818d-1f503ceef5812023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum SunscreenTITANIUM DIOXIDEAmway Corpa83f1192-c6c7-4145-b5af-29202191db782023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Buff L1W1TITANIUM DIOXIDEAmway Corpcba2462d-71ec-4ecb-b05a-5208ff8e22ad2023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1TITANIUM DIOXIDEAmway Corp19d08a86-5a60-4633-8a3c-96bab9a17fcc2023-10-21WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1TITANIUM DIOXIDEAmway Corpd17b1d46-478e-4f48-8fde-ac639bcdc4922023-10-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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