FDA.reportPublic FDA data

NDC 0378-3340-16 - XULANE

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
0378-3340
Requested NDC
0378-3340-16
Package NDCs from labels
0378-3340-16, 0378-3340-53
Manufacturer
A-S Medication Solutions
Effective date
2024-02-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XULANE - A-S Medication SolutionsA-S Medication Solutions2024-02-27HUMAN PRESCRIPTION DRUG LABEL
XULANE - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2022-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3340-16XULANE7 d in 1 PATCHPATCH716
0378-3340-16XULANE1 in 1 POUCHPATCH116
0378-3340-17XULANE1 in 1 POUCHPATCH116
0378-3340-17XULANE7 d in 1 PATCHPATCH716
0378-3340-32XULANE1 in 1 CARTONPATCH116
0378-3340-53XULANE3 in 1 CARTONPATCH316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3340XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 6 package rows20220505_f7848550-086a-43d8-8ae5-047f4b9e4382.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3340-16EA - Each0378-334029a3b2df-d582-4788-94c0-84f1ce21150712017-06-15
0378-3340-53EA - Each0378-3340fa993b2c-a314-4ad5-96f0-406dec3d5dc212014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
NORELGESTROMINACTIVE INGREDIENTR0TAY3X631XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
NORELGESTROMINACTIVE MOIETYR0TAY3X631XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]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 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
unii: T5L8T28FGP
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
unii: T5L8T28FGP
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions524c7188-ee84-4d5c-a6ab-e7a5ae36e22b2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
unii: T5L8T28FGP
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
unii: T5L8T28FGP
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
unii: T5L8T28FGP
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
unii: T5L8T28FGP
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
unii: T5L8T28FGP
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
unii: T5L8T28FGP
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
unii: T5L8T28FGP
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: T5L8T28FGP
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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