NDC 69420-1001-03 - 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
69420-1001
Requested NDC
69420-1001-03
Package NDCs from labels
69420-1001-3, 69420-1001-2, 69420-1001-1, 69420-1001-03
Manufacturer
SA3, LLC
Effective date
2026-09-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine Hydrochloride - SA3, LLCSA3, LLC2026-09-28HUMAN PRESCRIPTION DRUG LABEL
CYCLOBENZAPRINE HYDROCHLORIDE - Direct_RxDirect_Rx2026-08-27HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Proficient Rx LPProficient Rx LP2026-05-01HUMAN PRESCRIPTION DRUG LABEL
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyPreferred Pharmaceuticals, Inc.2026-04-01HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine HCL - PHOENIX RX LLCPHOENIX RX LLC2026-01-16HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-12-04HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine HCL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Quality Care Products LLCQuality Care Products LLC2024-12-17HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL
STARCH, CORN - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-05-07HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Unit Dose ServicesUnit Dose Services2021-10-22HUMAN PRESCRIPTION DRUG LABEL
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx onlyNuCare Pharmaceuticals, Inc.2021-02-23HUMAN PRESCRIPTION DRUG LABEL
NOpioid-LMC - Skya Health, LLCSkya Health, LLC2020-10-08HUMAN PRESCRIPTION DRUG LABEL
NOpioid-LMC - Skya Health, LLCSkya Health, LLC2020-10-01HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2015-12-10HUMAN PRESCRIPTION DRUG LABEL
CYCLOBENZAPRINE HYDROCHLORIDE - DIRECT RXDIRECT RX2015-08-10HUMAN PRESCRIPTION DRUG LABEL
Cyclobenzaprine Hydrochloride - All Pharma, LLCAll Pharma, LLC2015-03-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69420-1001-1Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10008
69420-1001-2Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
69420-1001-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69420-1001CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]7Current NDC, Legacy NDC, 3 package rows20220219_a4ae481f-9e47-470a-b4d1-5a33c0df8761.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-1001-1EA - Each69420-1001e6ea69a7-5e27-4f6a-a746-14512576dd4812015-05-05
69420-1001-2EA - Each69420-10012f4ecc40-7956-4cca-9600-72c4ab2186b412020-02-13
69420-1001-3EA - Each69420-1001ba51461b-7957-4db7-8540-c071baa5269f12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2

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 321 · 6,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
unii: 98PI200987
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
unii: 98PI200987
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
unii: 98PI200987
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
unii: 98PI200987
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-09-09Warnings, Adverse reactionsExact identifier
unii: 0VE05JYS2P
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
unii: 98PI200987
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
unii: 98PI200987
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESportpharm LLC71185d15-3fd7-42b7-83a6-8357e3aaef432026-09-05Warnings, Adverse reactionsExact identifier
rxcui: 828299
unii: 0VE05JYS2P
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990

Reported adverse events (FAERS/openFDA)#

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