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 6 of 117 · 2,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYfe81c68d-a579-4fe9-e053-6294a90a7bc02026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMajor Pharmaceuticals508e310e-067a-4f95-869a-e1da49aabe942026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078643
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 15FIX9V2JP
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY00b20a8c-debd-e930-e063-6394a90a7ed02026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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