FDA.reportPublic FDA data

NDC 69336-803 - KelaRx

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
69336-803
Package NDCs from labels
69336-803-30
Manufacturer
Sterling-Knight Pharmaceuticals, LLC
Effective date
2018-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KelaRx - Sterling-Knight Pharmaceuticals, LLCSterling-Knight Pharmaceuticals, LLC2018-09-21MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-803-30KelaRx1 in 1 TUBE12
69336-803-30KelaRx1 in 1 CARTON12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-803KELARX () [STERLING-KNIGHT PHARMACEUTICALS, LLC]22 package rows20180921_5561e6bf-b315-48ba-b86c-bba130bbe544.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-803-30GM - Gram69336-8035780b6f7-9711-41d9-80ad-7a58efc73ead12018-08-13

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 32 of 32 · 629 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
unii: 92RU3N3Y1O
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
Heartburn Plus Gas Relief Chewable Multi SymptomCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEWALGREEN CO.2c02e195-9c17-4ddc-80c2-52e51ae9eba02018-01-01WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONERichmond Pharmaceuticals, Inc.f4be1c0d-01fc-4681-9068-905ed31845342017-10-30WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONECVSd97cd600-6fc4-4d39-9e41-344e446465062017-08-09WarningsExact identifier
unii: 92RU3N3Y1O
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONESafewayd36b56a4-06f0-47ff-8add-4c327d60be222016-01-21WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONESafeway14a9fb00-707a-4b55-a060-82ad53a806e32016-01-08WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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