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 4 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy16ed7d7e-862f-db36-e063-6394a90a02a52026-06-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.106d9730-5938-8f27-e063-6294a90adc682026-06-23Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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