FDA.reportPublic FDA data

NDC 65162-993-04 - DOTTI

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
65162-993
Requested NDC
65162-993-04
Package NDCs from labels
65162-993-04, 65162-993-08
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOTTI - Bryant Ranch PrepackBryant Ranch Prepack2024-08-12HUMAN PRESCRIPTION DRUG LABEL
DOTTI - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2024-05-14HUMAN PRESCRIPTION DRUG LABEL
DOTTI - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2023-04-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-993-04DOTTI1 d in 1 POUCHPATCH, EXTENDED RELEASE110
65162-993-08DOTTI8 in 1 CARTONPATCH, EXTENDED RELEASE810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-993DOTTI (ESTRADIOL) PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 2 package rows20240607_53016d30-6b5f-49da-ac16-85ef415a5805.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-993-04EA - Each65162-9932319656a-c60a-45bb-a944-4acd432bf14b12019-07-02
65162-993-08EA - Each65162-99359127355-15fd-48d1-9a3e-d56a0afb536412019-07-02

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 5 of 12 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: FZ989GH94E
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
EstroPRO Homeopathic OrganotherapyAGNUS CASTUS, ANGELICA SIN, APIS MEL, CIMICIFUGA RAC, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM, GLYCYRRHIZA, OOPHORINUM, PROGESTERONE, SEPIAProBlen4696d365-7667-c25e-e063-6294a90a8dea2025-12-22WarningsExact identifier
unii: 4TI98Z838E
High Vitality TabAGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), PROTEUS (MORGANI)Deseret Biologicalsd13cfd09-8f8d-4b39-b60e-0e7886af2a562025-12-11WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c94738ff-dece-4fb6-bb44-4f8832a45f382025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC1c2cd11a-e010-20b2-e063-6294a90a52d52025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLPadagis Israel Pharmaceuticals Ltdf76232ed-b109-43d1-bf2e-d41b6420c37d2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackff3bcb07-f6fe-4582-948a-21dbf1e55f552025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINAL INSERTSESTRADIOLGlenmark Pharmaceuticals Inc., USA86620f6c-fd02-40df-98d5-3048dcd92c372025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
Estradiol VaginalESTRADIOLBryant Ranch Prepackf3806b5d-ebd6-43b4-adfa-a1fe86d806422025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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