FDA.reportPublic FDA data

The Indigo Cream

Product NDC
69417-120
Requested package NDC
69417-120-17
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69417-12069417-120-17IInactivated by FDA2026-07-31

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 142 · 2,830 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
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
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
unii: 8PI54V663Y
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
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
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
DocosanolDOCOSANOLYYBA Corp289e5003-7d08-c141-e063-6394a90abca32026-07-20WarningsExact identifier
unii: 9G1OE216XY
Cold Sore Fever Blister TreatmentDOCOSANOLSportpharm LLCe3e6c0b0-399f-41e4-9df9-109ee29179952026-07-12WarningsExact identifier
unii: 9G1OE216XY
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreensac3280b7-00aa-46cd-84e2-0a11992028ab2026-07-09WarningsExact identifier
unii: 9G1OE216XY
Cold Sore Fever Blister TreatmentDOCOSANOLWalgreens518bd432-f0d0-4fc4-944c-b9d1a01e20642026-07-09WarningsExact identifier
unii: 9G1OE216XY
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f728-a824-48a6-e063-6394a90acae72026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23653a-2481-bd15-e063-6394a90a71332026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB5 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a238f2d-efa9-01d1-e063-6294a90aae6f2026-07-08WarningsExact identifier
unii: 15FIX9V2JP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69417-120-032022-07-29C16284748780-1e4f33bdf-b001-d8a0-e053-dadaa90a6e4eTHE INDIGO CREAM
69417-120-172022-07-29C16284748780-1e4f33bdf-b001-d8a0-e053-dadaa90a6e4eTHE INDIGO CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69417-120-03The Indigo Cream1 in 1 BOXCREAM13
69417-120-03The Indigo Cream10 g in 1 TUBECREAM103
69417-120-17The Indigo Cream1 in 1 BOXCREAM13
69417-120-17The Indigo Cream50 g in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69417-120THE INDIGO CREAM (COLLOIDAL OATMEAL 2%) CREAM [TATCHA, INC.]3Legacy NDC, 4 package rows20220202_44f500eb-3af1-4d8e-9cb7-0f3f0d800d33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN44f500eb-3af1-4d8e-9cb7-0f3f0d800d333
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD44f500eb-3af1-4d8e-9cb7-0f3f0d800d333
1189915colloidal oatmeal 2 % Topical CreamSY44f500eb-3af1-4d8e-9cb7-0f3f0d800d333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69417-120-17694170120171 TUBE in 1 BOX (69417-120-17) > 50 g in 1 TUBE1 tube2018-08-020000-00-00NoNoCurrent