FDA.reportPublic FDA data

NDC 69238-1017-01 - Isotretinoin

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
69238-1017
Requested NDC
69238-1017-01
Package NDCs from labels
69238-1017-1, 69238-1017-3, 69238-1017-01
Manufacturer
Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WHITE WAX - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC2026-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1017-1Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1026
69238-1017-3Isotretinoin3 in 1 CARTONCAPSULE, LIQUID FILLED326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1017ISOTRETINOIN CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS NY LLC]26Current NDC, Legacy NDC, 2 package rows20231231_c2917c3d-3499-48a0-ba53-120cb979195d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1017-1EA - Each69238-10171bfa7546-7c95-413f-b76c-35bfb8d3977212018-03-08
69238-1017-3EA - Each69238-1017c6722be5-ef78-41c9-bd06-303831c4952c12018-02-20

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 57 of 121 · 2,402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
unii: 15FIX9V2JP
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact 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
Alabaster Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc3c4b7789-cd73-418e-94cb-834a06cb94082025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incc29cef40-065d-1f8d-e053-2995a90a43e72025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc0a506f55-ea6c-44d3-bab2-0a5875c437572025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inccd4da670-ad26-445e-a243-1e88b54d33352025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc6a6b8780-a11a-4602-aab4-1925d64f786e2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc748a9d28-8814-4394-ad7d-0d6ba868b0bc2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Lasting Foundation SPF 12 Merle NormanTITANIUM DIOXIDEMerle Norman Cosmetics, Incd31cfc74-7dcf-4af1-ba53-63fcad4144642025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.e12f5324-ed27-4a2e-bf49-f39f7fe351cb2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.3a30b330-7f5f-4a8e-b8bc-1cfaad72f9852025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 L10 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.c892e067-5a79-4903-a1f8-d5a9962c1d5c2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.0ad4ec84-7c82-4ab3-9070-a0764af123062025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF15 L20 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.4a08acf3-41e9-4021-9f4b-99a1fd86b2ec2025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Incdeaa0035-d030-4831-b2be-8b8bba5d8f552025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc.02a4e8f6-f257-4d30-8782-64b4d1622d462025-11-19WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup SPF 25 Merle NormanOCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Ince8b11940-6ac4-4c80-a732-2f86f2b7ebfe2025-11-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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