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 94 of 113 · 2,251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	11c37acc-abb8-8c38-e063-6294a90a7932	2024-02-19	Warnings	Exact identifier unii: 15FIX9V2JP
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	11c461f7-0f34-65ff-e063-6294a90a3da7	2024-02-19	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	711aa92c-81b0-42e4-b83f-9ce95116ec03	2024-02-16	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b8bc0021-bb4d-45f2-a570-3f2e61edf21d	2024-02-16	Warnings	Exact identifier unii: 15FIX9V2JP
Sheet SPF 30 Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma Inc.	bbb5b87c-d641-3ba2-e053-2a95a90a0f70	2024-02-14	Warnings	Exact identifier unii: 15FIX9V2JP
sheer tint SPF 45	BROAD SPECTRUM	CP Skin Health Group, Inc.	b7c5cedd-ff68-74de-e053-2a95a90a3796	2024-02-14	Warnings	Exact identifier unii: 15FIX9V2JP
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O	OCTINOXATE, TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10f7ec01-541b-a15a-e063-6294a90aa9df	2024-02-09	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour	TITANIUM DIOXIDE	COOLA, LLC	edfda0f5-0f72-5cc7-e053-2a95a90ae38d	2024-02-02	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush	ZINC OXIDE	COOLA, LLC	edc6754e-dabb-5bff-e053-2a95a90a7390	2024-02-02	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip	ZINC OXIDE	COOLA, LLC	ee01f936-81a9-a54d-e053-2a95a90a5227	2024-02-02	Warnings	Exact identifier unii: 15FIX9V2JP
toty Solaria Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e9d590d8-e71a-0715-e053-2a95a90a5acf	2024-02-01	Warnings	Exact identifier unii: 15FIX9V2JP
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	90c7a982-6442-4241-a60b-b5dfab2abb71	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
ATOMY DERMA CALMING SUN	TITANIUM DIOXIDE	ATOMY CO., LTD.	fd5fc3ba-6e7c-4e48-8e65-47c03141df45	2024-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
Shunly Radiant Translucent SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care LLC	20783833-ee7f-4425-b4ab-ab61cda5b2c8	2024-01-17	Warnings	Exact identifier unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care LLC	1aeb5e05-730c-4c5c-b164-ad9347b0cd93	2024-01-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	4a243c9f-ca88-47fb-8777-1da79c001c73	2024-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREEN	HOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACID	Sled Distribution, LLC	ec252876-7205-83ec-e053-2a95a90a1463	2024-01-15	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE	Cosmetique Active Production	fd2541e1-c409-40a8-9e3f-6ff69084ea66	2024-01-15	Warnings	Exact identifier unii: 15FIX9V2JP
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	c86303a0-7c8b-415e-acac-1070b7d0d445	2024-01-15	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	bc72048a-4786-44c2-97ce-022082281654	2024-01-15	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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