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 53 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Perfecting Makeup Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc0a506f55-ea6c-44d3-bab2-0a5875c437572025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inccd4da670-ad26-445e-a243-1e88b54d33352025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc6a6b8780-a11a-4602-aab4-1925d64f786e2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc748a9d28-8814-4394-ad7d-0d6ba868b0bc2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Lasting Foundation SPF 12 Merle NormanTITANIUM DIOXIDEMerle Norman Cosmetics, Incd31cfc74-7dcf-4af1-ba53-63fcad4144642025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.e12f5324-ed27-4a2e-bf49-f39f7fe351cb2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.3a30b330-7f5f-4a8e-b8bc-1cfaad72f9852025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 L10 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.c892e067-5a79-4903-a1f8-d5a9962c1d5c2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.0ad4ec84-7c82-4ab3-9070-a0764af123062025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF15 L20 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.4a08acf3-41e9-4021-9f4b-99a1fd86b2ec2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incdeaa0035-d030-4831-b2be-8b8bba5d8f552025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.02a4e8f6-f257-4d30-8782-64b4d1622d462025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc98ebaa5c-ba28-4e70-a45c-6545eb756d8f2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions1cb40f47-7fbb-4537-922d-04a08dd921c52025-11-19Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incff396aca-cf64-45f8-ba2e-c4fc55d6484b2025-11-18WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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