FDA.reportPublic FDA data

NDC 68084-075-11 - Tretinoin

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
68084-075
Requested NDC
68084-075-11
Package NDCs from labels
68084-075-11, 68084-075-21
Manufacturer
American Health Packaging
Effective date
2025-10-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tretinoin - American Health PackagingAmerican Health Packaging2025-10-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-075-11Tretinoin10 in 1 BLISTER PACKCAPSULE107
68084-075-21Tretinoin3 in 1 CARTONCAPSULE37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-075TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241031_b22d5a07-623a-4645-b87d-a151b86da8d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-075-11EA - Each68084-0755dc9d210-c8a6-4333-bdd7-5b90db00784512013-08-02
68084-075-21EA - Each68084-0759b2d182f-b0c2-45cf-a3ca-2ce81b956b5e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
NITROGENINACTIVE INGREDIENTN762921K75TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ATRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1

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 130 · 2,597 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
NutriLipid I.V. Fat EmulsionSOYBEAN OILB. Braun Medical Inc.193290b1-a0a1-4054-a22a-de5c9e7a8b732026-07-10Warnings, Adverse reactionsExact identifier
unii: 241ATL177A
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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