FDA.reportPublic FDA data

NDC 63304-754 - Amoxicillin and Clavulanate Potassium

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
63304-754
Package NDCs from labels
63304-754-03, 63304-754-20, 63304-754-01, 63304-754-21
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and Clavulanate Potassium - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-05-21HUMAN PRESCRIPTION DRUG LABEL
Amoxicillin and clavulanate potassium - Ranbaxy Pharmaceuticals Inc.Ranbaxy Pharmaceuticals Inc.2008-05-01HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-754-01Amoxicillin and clavulanate potassium100 in 1 BOTTLETABLET, CHEWABLE1001
63304-754-03Amoxicillin and clavulanate potassium10 in 1 BOTTLETABLET, CHEWABLE101
63304-754-20Amoxicillin and clavulanate potassium20 in 1 BOTTLETABLET, CHEWABLE201
63304-754-21Amoxicillin and clavulanate potassium20 in 1 BLISTER PACKTABLET, CHEWABLE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-754AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]14 package rows20080602_b897c800-24a2-4e76-8668-498c5515c3d0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-754-20EA - Each63304-75413dc1559-c20a-4ec1-afe6-8fbcbdf2a0f712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
AmoxicillinACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Clavulanate potassiumACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
AMOXICILLINACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
AmoxicillinACTIVE MOIETY804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Clavulanic acidACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
AspartameINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
Colloidal silicon dioxideINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
FD&C red No. 40 aluminum lakeINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Flavor strawberryINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Flavor strawberry guaranaINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
GlycineINACTIVE INGREDIENTTE7660XO1CAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
MannitolINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
Mint cream flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Monosodium citrateINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Orange cream flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
PovidoneINACTIVE INGREDIENTFZ989GH94EAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
Sodium citrate( as dihydrate)INACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Sodium starch glycolateINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]1
Tropical blend flavorINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]1
Xanthan gumINACTIVE INGREDIENTAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, CHEWABLE [RANBAXY PHARMACEUTICALS INC.]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 7 of 54 · 1,072 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPe08c1bee-14c8-4bd1-898c-1874251dadf82026-06-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINProficient Rx LP313ea909-5b1b-41ff-a0db-5aadc12e2e4f2026-06-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPef03286b-4ba7-4952-9ab1-90cacf3005042026-06-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack263a2902-f85c-46b6-8d5b-8c99f5c4b7062026-05-27Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINCoupler LLC52bd03c6-528a-c443-e063-6394a90aad392026-05-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMRedpharm Drug5250085e-5509-c577-e063-6294a90a9b872026-05-21Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5155ca5d-fe58-42b4-e063-6394a90ab1352026-05-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINBryant Ranch Prepackbe7d8459-b8e6-499a-ab87-99bd174925252026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINQPharma, Inc60c788d1-6c91-4456-848a-893e649e90be2026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINQPharma Incddd1307d-3216-0e59-e053-2995a90ad19d2026-05-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMCoupler LLC513b6211-c73b-7e66-e063-6394a90a2aa12026-05-07Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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