FDA.reportPublic FDA data

NDC 68084-044-11 - Paroxetine

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
68084-044
Requested NDC
68084-044-11
Package NDCs from labels
68084-044-11, 68084-044-01, 68084-044-65
Manufacturer
American Health Packaging
Effective date
2026-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Paroxetine - American Health PackagingAmerican Health Packaging2026-05-13HUMAN PRESCRIPTION DRUG LABEL
Paroxetine - Cardinal HealthCardinal Health2020-06-15HUMAN 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
68084-044-01Paroxetine100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10018
68084-044-11Paroxetine1 in 1 BLISTER PACKTABLET, FILM COATED118
68084-044-65Paroxetine50 in 1 CARTONTABLET, FILM COATED5018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-044PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]15Current NDC, Legacy NDC, 3 package rows20240504_b5a8f864-a53d-48d9-aca6-6b64017fb168.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-044-01EA - Each68084-044d54bd753-ee73-4446-b628-b9ca76aaa95e12012-07-24
68084-044-11EA - Each68084-044a52f8ffc-d53e-4f32-9d49-7d7ca7b307c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]6

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 53 of 109 · 2,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
unii: 15FIX9V2JP
SULWHASOO PERFECTING CUSHION NO. 25OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
unii: 15FIX9V2JP
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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