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 3 of 8 · 156 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
unii: T5L8T28FGP
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
unii: T5L8T28FGP
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1534809
unii: R0TAY3X631
unii: 423D2T571U
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
unii: T5L8T28FGP
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
unii: T5L8T28FGP
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
unii: T5L8T28FGP
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
unii: T5L8T28FGP
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
unii: T5L8T28FGP
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
unii: T5L8T28FGP
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
unii: T5L8T28FGP
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
unii: T5L8T28FGP
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
unii: T5L8T28FGP
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
unii: T5L8T28FGP
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
unii: T5L8T28FGP
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLOrganon LLC55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d972025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
unii: T5L8T28FGP
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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