Home NDC 69417-120 The Indigo Cream
Product NDC 69417-120
11-digit product format 694170120
Labeler code 69417
Product ID 69417-120_b1fdfc36-f245-430b-bf7a-9edae013b4e7
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal 2%
Dosage form CREAM
Route TOPICAL
Labeler TATCHA, Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-08-02
Marketing end 0000-00-00
Substance OATMEAL
Active strength 2 mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 69417-120 I Inactivated by FDA 2026-07-31 excluded package package 69417-120 69417-120-03 I Inactivated by FDA 2026-07-31 excluded package package 69417-120 69417-120-17 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Astringent CALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATE Granulation Technology, Inc. 1c2bf19c-2f32-4a22-a371-16cc744dce76 2025-06-12 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. 91f24a0c-276f-4962-8da8-462b1f42040e 2019-05-17 Warnings Exact identifier Eczema Care Moisturizing 3 oz. COLLOIDAL OATMEAL Rejoice International Inc. 83967d26-159a-e95c-e053-2991aa0af53a 2019-03-08 Warnings Exact identifier Oatmeal Skin Relief Calming . 8oz DIMETHICONE Rejoice International Inc. 8384dc52-ba36-da3d-e053-2a91aa0a4f40 2019-03-07 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. b8832ee7-3e13-456b-b301-dad7473a032b 2019-02-04 Warnings Exact identifier BURTS BEES BABY BEE DIAPER RASH ZINC OXIDE BURT'S BEES, INC. 168b31b1-9260-61f8-e054-00144ff8d46c 2018-12-21 Warnings Exact identifier Balmex Diaper Rash ZINC OXIDE Randob Labs,Ltd. f202dd0e-7c61-4ea1-a5f6-e90898366ba3 2018-11-13 Warnings Exact identifier BALMEX ADULT CARE RASH ZINC OXIDE Randob Labs,Ltd. 9443a987-c7b2-4b0d-a9dc-02233135af81 2018-11-13 Warnings Exact identifier BALMEX MULTI-PURPOSE PETROLATUM Randob Labs,Ltd. 83a9ba1a-b708-47e2-a4a3-ef847e1bb792 2018-11-13 Warnings Exact identifier Natures Choice Vitamins A and D A AND D OINTMENT Unipack, Inc. 17861122-2231-4a54-b3d8-894153c708d7 2018-01-15 Warnings Exact identifier MG217 Eczema Face COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5f10697e-7f0c-f2b7-e053-2991aa0aabde 2017-11-30 Warnings Exact identifier MG217 Baby Eczema COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5d65052d-2972-544d-e053-2a91aa0afa3e 2017-11-28 Warnings Exact identifier Vitamin A and D LANOLIN AND PETROLATUM Family Dollar Services Inc 4826b36d-3326-4f5c-8b22-c5ff79e55062 2017-11-08 Warnings Exact identifier TriCalm Hydrogel ALUMINUM ACETATE Modular Thermal Technologies LLC Dba Life Wear Technologies 5cb42ffb-3655-4c38-bf84-1cf33c82df10 2017-03-23 Warnings Exact identifier CVS Health Diaper Rash ZINC OXIDE CVS Health 12f786a0-0960-4b98-9f0b-dcf3725a9866 2017-03-20 Warnings Exact identifier ARGAN AIR WATER BANG ESSENCE DIMETHICONE Pioom Cosmetic Co.,ltd 34e79668-0710-5753-e054-00144ff88e88 2016-06-08 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69417-120-03 The Indigo Cream 1 in 1 BOX CREAM 1 3 69417-120-03 The Indigo Cream 10 g in 1 TUBE CREAM 10 3 69417-120-17 The Indigo Cream 1 in 1 BOX CREAM 1 3 69417-120-17 The Indigo Cream 50 g in 1 TUBE CREAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69417-120 THE INDIGO CREAM (COLLOIDAL OATMEAL 2%) CREAM [TATCHA, INC.] 3 Legacy NDC, 4 package rows 20220202_44f500eb-3af1-4d8e-9cb7-0f3f0d800d33.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69417-120-03 69417012003 1 TUBE in 1 BOX (69417-120-03) > 10 g in 1 TUBE 1 tube 2018-08-02 0000-00-00 No No Current 69417-120-17 69417012017 1 TUBE in 1 BOX (69417-120-17) > 50 g in 1 TUBE 1 tube 2018-08-02 0000-00-00 No No Current