FDA.reportPublic FDA data

NDC 21695-014-60 - Baclofen

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
21695-014
Requested NDC
21695-014-60
Package NDCs from labels
21695-014-30, 21695-014-42, 21695-014-60, 21695-014-90, 21695-014-72
Manufacturer
Rebel Distributors Corp.
Effective date
2009-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Baclofen Tablets USP 10mg & 20mgRebel Distributors Corp.2009-12-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-014-422019-09-24C16284748780-1934fe258-4c6e-48b1-e053-8cdaa90a720aBaclofen Tablets USP 10mg & 20mg
21695-014-722019-09-24C16284748780-1934fe258-4c6e-48b1-e053-8cdaa90a720aBaclofen Tablets USP 10mg & 20mg
21695-014-902019-09-24C16284748780-1934fe258-4c6e-48b1-e053-8cdaa90a720aBaclofen Tablets USP 10mg & 20mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-014-30Baclofen30 in 1 BOTTLETABLET301
21695-014-42Baclofen42 in 1 BOTTLETABLET421
21695-014-60Baclofen60 in 1 BOTTLETABLET601
21695-014-72Baclofen120 in 1 BOTTLETABLET1201
21695-014-90Baclofen90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-014BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 package rows20100329_d88886cc-62c0-44dd-8a3f-cac601832d8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-014-30EA - Each21695-014045b5479-8a48-4d8c-9230-f5d2a183b56912012-07-24
21695-014-60EA - Each21695-014f974850f-d5fd-43d0-8ba4-4c7e7a27757712012-07-24
21695-014-72EA - Each21695-01467d2f2c6-d0bc-41c7-872b-eb0966b5425512012-07-24
21695-014-90EA - Each21695-01410ba6395-b45c-47ec-8f19-96e039588df312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]1

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 5 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
BaclofenBACLOFENNorthwind Health Company, LLC06bcfb08-2ada-f803-e063-6394a90a826b2025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BACLOFENBACLOFENAdvanced Rx of Tennessee, LLC459ec5f5-4f99-e917-e063-6294a90a23cd2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENWilshire Pharmaceuticals, Inc.4585aafe-0af8-4786-a419-6a7e76671ca22025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
FLEQSUVYBACLOFENAzurity Pharmaceuticals, Inc.9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa2025-12-16Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BaclofenBACLOFENPHOENIX RX LLC45c6d45d-95d5-21b8-e063-6294a90a79552025-12-12Warnings, Adverse reactionsExact identifier
rxcui: 197392
unii: H789N3FKE8
BaclofenBACLOFENUpsher-Smith Laboratories, LLCb2747a9d-5fca-4657-9e4b-4112607f30d82025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 197391
rxcui: 197392
unii: H789N3FKE8
BACLOFENBACLOFENAdvagen Pharma Limitedd63af5f0-c275-480b-89b5-6cf1ad55ab632025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENSOLA Pharmaceuticals, LLC7b308b35-8c08-458d-860e-c78d057e82602025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8
BaclofenBACLOFENANI Pharmaceuticals, Inc.c73ed3af-8e8a-4a18-90fc-a0f2dcc641d02025-12-04Warnings, Adverse reactionsExact identifier
unii: H789N3FKE8
BACLOFENBACLOFENProficient Rx LP0680301a-1649-46c4-b74e-ab03967945d02025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 197391
unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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