FDA.reportPublic FDA data

NDC 54868-3105-1 - Amoxicillin

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
54868-3105
Requested NDC
54868-3105-1
Package NDCs from labels
54868-3105-0, 54868-3105-2, 54868-3105-3, 54868-3105-1
Manufacturer
Physicians Total Care, Inc.
Effective date
2012-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-10-19HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-3105-02019-09-24C16284748780-19350213a-42fb-c013-e053-90daa90a1393afbcbf79-e7cd-4615-a999-9941573882b5
54868-3105-22019-09-24C16284748780-19350213a-42fb-c013-e053-90daa90a1393afbcbf79-e7cd-4615-a999-9941573882b5
54868-3105-32019-09-24C16284748780-19350213a-42fb-c013-e053-90daa90a1393afbcbf79-e7cd-4615-a999-9941573882b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-3105-0Amoxicillin30 in 1 BOTTLETABLET, CHEWABLE302
54868-3105-2Amoxicillin20 in 1 BOTTLETABLET, CHEWABLE202
54868-3105-3Amoxicillin40 in 1 BOTTLETABLET, CHEWABLE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-3105AMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]23 package rows20131019_afbcbf79-e7cd-4615-a999-9941573882b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-3105-0EA - Each54868-3105c2214c25-a6fe-4abd-9805-41dabf4ce98812012-07-24
54868-3105-1EA - Each54868-310583a9cfa8-23c3-4df2-9eef-058dec5887df12013-02-11
54868-3105-2EA - Each54868-3105c985ea1c-4271-4086-9d98-cd682280f90a12012-07-24
54868-3105-3EA - Each54868-31054e410285-3260-47b4-a752-83fa02b21a7312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]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 8 of 21 · 405 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINQPharma Inc2772a745-1276-405b-b229-95edf5534b2a2025-12-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4528f48d-5bda-b307-e063-6294a90a294c2025-12-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.6285c4f2-c13b-49a9-e053-2991aa0a2b032025-11-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.b509d0eb-fe01-4902-89ae-a0dc7f7c7f932025-11-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.071086f5-e4ed-b1d9-e063-6294a90ad3042025-11-13Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack22cd4e96-2288-470c-9264-8058cd7db9b02025-11-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AmoxicillinAMOXICILLINBryant Ranch Prepackbbaeb509-ad04-4668-a1db-4358038893f22025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackaa15e6f6-1eb1-41ab-b3cb-bf24d09fc8822025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackb5e66987-09e3-45b2-88ba-59c8647d724e2025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackeef98beb-57d9-448a-b89c-6acd6f7b443e2025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.e340b67b-332e-4e0c-aebf-ad4872dc5ed42025-10-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.cc445a39-d84c-4b76-9fb8-ae302e7cd96b2025-10-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.039d2677-b04f-436c-e063-6294a90ac5192025-10-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.d0938df9-9065-47eb-9eae-0722ed1411a12025-10-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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