FDA.reportPublic FDA data

NDC 68682-925 - Erythromycin and Benzoyl Peroxide

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
68682-925
Package NDCs from labels
68682-925-16
Manufacturer
Oceanside Pharmaceuticals | Bausch Health Companies Inc
Effective date
2019-06-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Erythromycin - Oceanside Pharmaceuticals | Bausch Health Companies IncOceanside Pharmaceuticals | Bausch Health Companies Inc2019-06-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-925-16Erythromycin and Benzoyl Peroxide1.6 g in 1 VIAL, PLASTICGEL1.6 g30 mg in 1g9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-925ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]9Unmatched20191010_be5bce27-bbb7-4503-b609-d89a77ee1e05.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1WERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RERYTHROMYCIN AND BENZOYL PEROXIDE KIT [OCEANSIDE PHARMACEUTICALS]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 177 of 179 · 3,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINProficient Rx LP5101bf55-cacf-42bf-8dd1-2a29e80ca6f12022-07-01Adverse reactionsExact identifier
unii: 63937KV33D
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd92dcba02-f42f-482d-8cd5-2b5ab8fa540a2022-06-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDETeva Pharmaceuticals, Inc.05babd5f-18ab-4646-8962-cb000ed0f9a82022-05-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
ErythromycinERYTHROMYCINProficient Rx LP62896bec-669e-4f20-a1e4-4f99afd35d322022-04-01Adverse reactionsExact identifier
unii: 63937KV33D
ErythromycinERYTHROMYCINAsclemed USA, Inc.bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c2022-03-07Adverse reactionsExact identifier
unii: 63937KV33D
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ErythromycinERYTHROMYCINAsclemed USA, Inc.7810e881-5130-4a94-b2e0-9f63f8a7a5042021-11-30Adverse reactionsExact identifier
unii: 63937KV33D
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ErythromycinERYTHROMYCINOrange Pharmaceuticals USA LLC379ed8f7-b54f-495f-932e-cd0e4c6911342021-07-05Warnings, Adverse reactionsExact identifier
unii: 63937KV33D
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
BenzamycinERYTHROMYCIN AND BENZOYL PEROXIDEBausch Health US, LLCc8c05e98-ec28-4636-8e5c-9a2557483e3c2020-11-30Warnings, Adverse reactionsExact identifier
application number: NDA050557
rxcui: 244374
rxcui: 308694

Reported adverse events (FAERS/openFDA)#

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