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 4 of 32 · 640 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
unii: 92RU3N3Y1O
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
unii: 92RU3N3Y1O
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 92RU3N3Y1O
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsExact identifier
unii: 92RU3N3Y1O
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
unii: 92RU3N3Y1O
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
unii: 92RU3N3Y1O
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 92RU3N3Y1O
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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