FDA.reportPublic FDA data

NDC 68084-101-11 - Fluoxetine

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
68084-101
Requested NDC
68084-101-11
Package NDCs from labels
68084-101-11, 68084-101-01
Manufacturer
American Health Packaging
Effective date
2022-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - American Health PackagingAmerican Health Packaging2022-06-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-101-01EA - Each68084-10159f8afe0-9f86-4827-bf07-834d978c5c6d12014-01-04
68084-101-11EA - Each68084-101a5edac94-8d05-478e-88e5-338ee4d08e1b12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FLUOXETINEACTIVE MOIETY01K63SUP8DFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71OFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [AMERICAN HEALTH PACKAGING]3

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 80 of 142 · 2,822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
unii: 15FIX9V2JP
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Summit Smelling SaltsSUMMIT SMELLING SALTSWashburn Ventures LLC36b6ed08-4a98-6b31-e063-6394a90a6fb72025-06-16WarningsExact identifier
unii: 5138Q19F1X
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
unii: 15FIX9V2JP
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
unii: 15FIX9V2JP
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
unii: 15FIX9V2JP
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
unii: 15FIX9V2JP
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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