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 178 of 179 · 3,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
unii: F05Q2T2JA0
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
AcanyaCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC3dcd2c96-72b1-4a9f-b65c-08198d63b7df2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticalsedae294f-cc8b-4f94-8d90-4c764fda307b2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
unii: F05Q2T2JA0
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
unii: W9WZN9A0GM
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
rxcui: 308694
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
unii: W9WZN9A0GM
Erythromycin and Benzoyl PeroxideERYTHROMYCIN AND BENZOYL PEROXIDEOceanside Pharmaceuticalsbe5bce27-bbb7-4503-b609-d89a77ee1e052019-06-03Warnings, Adverse reactionsExact identifier
application number: NDA050557
ndc (package): 68682-923-23
ndc (package): 68682-925-16
ndc (package): 68682-924-08
ndc (package): 68682-901-46
ndc (package): 68682-900-23
ndc (package): 68682-922-46
ndc (product): 68682-900
ndc (product): 68682-901
rxcui: 244374
rxcui: 308694
spl id: eba108cb-67ec-4f94-8fad-0afb3a52899b
spl set id: be5bce27-bbb7-4503-b609-d89a77ee1e05
ERYTHROMYCINERYTHROMYCINArbor Pharmaceuticals, Inc.ddd9ad9a-fc60-409a-a2b3-be51482ef7512019-03-19Warnings, Adverse reactionsExact identifier
unii: 63937KV33D
STOOL SOFTENING SENNA LAXATIVESENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MGTARGET CORPORATION7c74bd91-6687-2b89-e053-2a91aa0ad6b82019-02-28WarningsExact identifier
unii: F05Q2T2JA0
ErythromycinERYTHROMYCINWilshire Pharmaceuticalsf2efbc94-64f7-4130-ab23-e5983854f7302019-01-14Warnings, Adverse reactionsExact identifier
unii: 63937KV33D
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
ErythromycinERYTHROMYCINArbor Pharmaceuticals, Inc.ca1326d6-c5c6-4572-96b6-e56cd944799c2018-12-04Warnings, Adverse reactionsExact identifier
unii: 63937KV33D
ERY-TABERYTHROMYCINArbor Pharmaceuticals, Inc.fda44eb6-7901-4b80-ba0b-216f6cacf3fd2018-12-04Warnings, Adverse reactionsExact identifier
unii: 63937KV33D
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.461859ad-7833-47ae-90da-1dea5f26cc4b2018-12-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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