FDA.reportPublic FDA data

NDC 85509-1001-01 - Cyclobenzaprine HCL

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
85509-1001
Requested NDC
85509-1001-01
Package NDCs from labels
85509-1001-9, 85509-1001-6, 85509-1001-3, 85509-1001-1, 85509-1001-01
Manufacturer
PHOENIX RX LLC
Effective date
2026-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine HCL - PHOENIX RX LLCPHOENIX RX LLC2026-01-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1001-1Cyclobenzaprine HCL120 in 1 BOTTLETABLET, FILM COATED1202
85509-1001-3Cyclobenzaprine HCL30 in 1 BOTTLETABLET, FILM COATED302
85509-1001-6Cyclobenzaprine HCL60 in 1 BOTTLETABLET, FILM COATED602
85509-1001-9Cyclobenzaprine HCL90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1001-1EA - Each85509-100128522ea1-ab13-471d-8dbc-728cefe3de1412025-09-12
85509-1001-3EA - Each85509-1001bb8bece2-242a-4473-816b-c5dcd4acbe2212025-09-12
85509-1001-6EA - Each85509-100112fefb56-7807-47b3-be63-4b7cb0931ed312025-09-12
85509-1001-9EA - Each85509-100144e90feb-0a42-423d-89ca-676e3078da5612025-09-12

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 4 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCdae3be94-a40c-5be1-e053-2a95a90a14842026-01-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENorthwind Health Company, LLCe04eea45-12ec-4d2b-e053-2a95a90a6b762026-01-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf32bceda-1d24-322d-e053-2995a90aae1b2026-01-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf708cf0f-8373-14a2-e053-6394a90ab3fe2026-01-01Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLC1912d134-a909-5511-e063-6294a90aea292025-12-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMacleods Pharmaceuticals Limited1af467cb-7b21-4084-bb54-4634e928b1672025-12-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEGolden State Medical Supply, Inc.15c0c7aa-8c54-4040-a1bf-2a7b421ad33f2025-12-11Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions81917fa4-c79c-46e2-bfbb-507fc0d7ed1b2025-12-04Warnings, Adverse reactionsExact identifier
application number: ANDA078722
rxcui: 828299
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43ce2c79-ec4a-5120-e063-6394a90af6e12025-12-03Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQPharma Incfbe6ba88-0581-50ef-e053-6394a90ab0862025-12-02Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions6b06b11c-0546-4f6e-9509-ba612bbcb9fd2025-11-19Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsf3187074-6b55-44a3-b969-40a808eb034a2025-11-19Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba2025-11-19Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions1cb40f47-7fbb-4537-922d-04a08dd921c52025-11-19Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAmerican Health Packaging269bc278-963d-4830-816a-39bb4bf8c9362025-11-13Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC4383b26f-c39f-3d6a-e063-6294a90aba032025-11-13Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rx4c054230-1978-44d2-9467-ed19946191132025-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA077563
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvPAK64f6d1be-4067-a5c7-2343-4aed651a0cac2025-10-28Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAvPAKe530fd1e-06fd-0432-e053-2995a90adf5f2025-10-28Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e505c31b-4618-4e4f-8da6-92030464004f2025-10-15Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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