FDA.reportPublic FDA data

NDC 68071-3475-01 - CYCLOBENZAPRINE HYDROCHLORIDE

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
68071-3475
Requested NDC
68071-3475-01
Package NDCs from labels
68071-3475-2, 68071-3475-3, 68071-3475-1, 68071-3475-4, 68071-3475-9, 68071-3475-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine hydrochloride, USPNuCare Pharmaceuticals,Inc.2025-01-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3475-1CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLETABLET, FILM COATED205
68071-3475-2CYCLOBENZAPRINE HYDROCHLORIDE12 in 1 BOTTLETABLET, FILM COATED125
68071-3475-3CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED305
68071-3475-4CYCLOBENZAPRINE HYDROCHLORIDE14 in 1 BOTTLETABLET, FILM COATED145
68071-3475-9CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3475CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, 5 package rows20250116_01e18825-1cf9-a98c-e063-6294a90ae0a4.zip

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 88 of 145 · 2,885 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fbd38abb-02ae-1a36-e053-6294a90abe652025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.418e3974-f7dd-4f27-bee5-3c2fb0531c4c2025-02-03Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828299
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack05641925-7b10-4b30-b6e8-44b416a5e77e2025-02-03Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack96207b29-033b-46a3-961f-e5125288d50f2025-02-03Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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