FDA.reportPublic FDA data

NDC 67296-2084-01 - 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
67296-2084
Requested NDC
67296-2084-01
Package NDCs from labels
67296-2084-1, 67296-2084-2, 67296-2084-3, 67296-2084-4, 67296-2084-01
Manufacturer
Redpharm Drug
Effective date
2025-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOBENZAPRINE HYDROCHLORIDE - Redpharm DrugRedpharm Drug2025-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2084-1CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLETABLET, FILM COATED153
67296-2084-2CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED103
67296-2084-3CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
67296-2084-4CYCLOBENZAPRINE HYDROCHLORIDE21 in 1 BOTTLETABLET, FILM COATED213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2084CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG]3Current NDC, 4 package rows20250410_0ab1b6f8-5d73-f97a-e063-6294a90a9fbf.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 4 of 147 · 2,940 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.eb2b24b1-2851-440f-9075-b6a123a1fd5c2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDECardinal Health 107, LLCdf902d94-9d2b-4139-aebb-3eb6b8b8cd542026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.f2eb32c3-3da0-4938-9ed9-ea8420450fde2026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8c66b5ed-f773-0779-e053-2995a90ad1f12026-07-20Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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