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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cyclobenzaprine hydrochloride	ACTIVE INGREDIENT	0VE05JYS2P	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
Cyclobenzaprine	ACTIVE MOIETY	69O5WQQ5TI	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMRIX (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 99 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
SOOTHE Daily Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	9acbf663-15e4-4572-a267-56afa58a347b	2023-11-30	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 60 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Derma Care Research Labs, LLC	0aae69f1-66bf-a199-e063-6394a90a3d75	2023-11-21	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a9c1b3f-656d-0d62-e063-6394a90a4731	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	581e8289-1406-45b6-9786-753800665fad	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a4cea12-7e00-d201-e063-6394a90a6691	2023-11-16	Warnings	Exact identifier unii: 15FIX9V2JP
Max Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Peter Thomas Roth Labs, LLC	0980992c-6488-2fa1-e063-6294a90a41ea	2023-11-14	Warnings	Exact identifier unii: 15FIX9V2JP
Saccharum officinale	SUCROSE	Boiron	86d04552-b31a-0fcf-e053-2991aa0acecd	2023-11-14		Exact identifier unii: C151H8M554
Saccharum officinale	SUCROSE	Boiron	86d05561-6f09-6f1f-e053-2a91aa0a4b98	2023-11-14		Exact identifier unii: C151H8M554
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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