FDA.reportPublic FDA data

NDC 85509-1014-06 - 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
85509-1014
Requested NDC
85509-1014-06
Package NDCs from labels
85509-1014-3, 85509-1014-6, 85509-1014-9, 85509-1014-06
Manufacturer
PHOENIX RX LLC
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOBENZAPRINE HYDROCHLORIDE - PHOENIX RX LLCPHOENIX RX LLC2025-07-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1014-3CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301
85509-1014-6CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
85509-1014-9CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1014-3EA - Each85509-101454a40939-8f50-4dc8-893e-5d79da57130712025-09-12
85509-1014-6EA - Each85509-1014bc3af296-cf05-4878-832f-54f216f933ac12025-09-12
85509-1014-9EA - Each85509-1014c375f54a-a0e7-472a-8382-1108ef731a0512025-09-12

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 77 of 144 · 2,871 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
unii: 15FIX9V2JP
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
unii: 15FIX9V2JP
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
unii: 15FIX9V2JP
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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