FDA.reportPublic FDA data

NDC 70518-3474-01 - 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
70518-3474
Requested NDC
70518-3474-01
Package NDCs from labels
70518-3474-1, 70518-3474-0, 70518-3474-2, 70518-3474-3, 70518-3474-4, 70518-3474-5, 70518-3474-6, 70518-3474-7, 70518-3474-8, 70518-3474-9, 70518-3474-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine Hydrochloride Tablets, USP Rx onlyREMEDYREPACK INC.2026-08-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3474-0Cyclobenzaprine Hydrochloride100 in 1 BOXTABLET, FILM COATED10013
70518-3474-1Cyclobenzaprine Hydrochloride1 in 1 POUCHTABLET, FILM COATED113
70518-3474-2Cyclobenzaprine Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED513
70518-3474-3Cyclobenzaprine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED613
70518-3474-4Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-3474-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1513
70518-3474-6Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
70518-3474-7Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013
70518-3474-8Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-3474-9Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3474CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 10 package rows20241213_b09ca979-ab6b-441b-a66f-41ca32eae6cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3474-8EA - Each70518-34743c1f5d06-642d-41c1-ad8c-aca5302bfddb12026-01-08
70518-3474-9EA - Each70518-3474f98b72c0-57fe-4c9f-a3be-7ff4f77b764a12026-01-08

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 117 · 2,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPdfe7288c-a477-4f32-a9ab-00cc981a1a572026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy16ed7d7e-862f-db36-e063-6394a90a02a52026-06-26Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.106d9730-5938-8f27-e063-6294a90adc682026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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