FDA.reportPublic FDA data

NDC 0378-9124-16 - FENTANYL

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
0378-9124
Requested NDC
0378-9124-16
Package NDCs from labels
0378-9124-16, 0378-9124-98
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2025-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENTANYL - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-12-15HUMAN PRESCRIPTION DRUG LABEL
Fentanyl - Lake Erie Medical DBA Quality Care Products LLCLake Erie Medical DBA Quality Care Products LLC2019-10-22HUMAN PRESCRIPTION DRUG LABEL
Fentanyl - Physicians Total Care, Inc.Physicians Total Care, Inc.2009-12-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-9124-16FENTANYL1 in 1 POUCHPATCH127
0378-9124-16FENTANYL72 h in 1 PATCHPATCH7227
0378-9124-98FENTANYL5 in 1 CARTONPATCH527

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9124FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 3 package rows20241019_2a2238e9-4b5d-c56d-8663-dd354ff9ae0c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9124-16EA - Each0378-9124f642fe72-09eb-4ed4-8263-249306f8ca5112012-07-24
0378-9124-98EA - Each0378-91249f18f012-f3bd-4078-ac89-99416e32190912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)INACTIVE INGREDIENT9N5G1G3D3HFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]2
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFENTANYL PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)INACTIVE INGREDIENT9N5G1G3D3HFENTANYL PATCH [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]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 2 of 32 · 640 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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