FDA.reportPublic FDA data

NDC 71276-080-01 - OXY STEM M

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
71276-080
Requested NDC
71276-080-01
Package NDCs from labels
71276-080-01, 71276-080-02
Manufacturer
ULAB | U-LAB Switzerland AG
Effective date
2017-03-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OXY STEM M - ULAB | U-LAB Switzerland AGULAB | U-LAB Switzerland AG2017-03-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71276-080-022020-01-31C16284748780-19d75b9cf-fe1e-f424-e053-dadaa90a57ce31715101-fac0-43b6-b86b-5c8082c73c28

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71276-080-01OXY STEM M50 mL in 1 BOTTLE, PUMPCREAM501
71276-080-02OXY STEM M1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71276-080OXY STEM M (DIMETHICONE) CREAM [ULAB]1Legacy NDC, 2 package rows20170322_31715101-fac0-43b6-b86b-5c8082c73c28.zip

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 53 of 54 · 1,070 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
unii: 92RU3N3Y1O
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
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Loperamide Hydrochloride, SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEGuardian Drug Company1b79204e-8a99-455b-84d6-f381fd7d11352021-06-01WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
unii: 92RU3N3Y1O
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
unii: 92RU3N3Y1O
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
unii: 92RU3N3Y1O
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Gas ReliefSIMETHICONEAdvance Pharmaceutical Inc.531b9850-c93e-4a0c-bd1c-7da33d752d802018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONEAdvance Pharmaceutical Inc.e11928e8-b9db-43c5-972b-33b325090dfc2018-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Heartburn Plus Gas Relief Chewable Multi SymptomCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEWALGREEN CO.2c02e195-9c17-4ddc-80c2-52e51ae9eba02018-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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