FDA.reportPublic FDA data

NDC 85509-1920-03 - 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
85509-1920
Requested NDC
85509-1920-03
Package NDCs from labels
85509-1920-3, 85509-1920-9, 85509-1920-6, 85509-1920-03
Manufacturer
PHOENIX RX LLC
Effective date
2025-07-21
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 LLC2025-07-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1920-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
85509-1920-6Cyclobenzaprine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
85509-1920-9Cyclobenzaprine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1920-3EA - Each85509-1920921d20ad-3dd0-4781-914b-cc744c244a4f12025-09-12
85509-1920-6EA - Each85509-19200be5592f-de5e-4237-b834-236d02b42b5d12025-09-12
85509-1920-9EA - Each85509-19206ce2778a-dccf-45a0-a393-000551097eec12025-09-12

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 1 of 119 · 2,370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-09-09Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESportpharm LLC71185d15-3fd7-42b7-83a6-8357e3aaef432026-09-05Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.37056cab-953e-43ba-9b4c-163a739a52f72026-09-02Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.30e61110-5bc8-4134-8456-5385584797352026-09-01Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828358
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.ba659e1a-0091-45f6-b418-f4f36c9a2c792026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 828358
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.3175d24d-e8a0-4f14-bed9-a60ad59ac7e72026-08-28Warnings, Adverse reactionsExact identifier
application number: NDA021777
rxcui: 828353
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect_Rx903e3a5a-7c58-b70d-e053-2a95a90a6f9d2026-08-27Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.e4ed7ad2-cf58-4fdb-bc8c-d89f23b012102026-08-17Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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