FDA.reportPublic FDA data

The Indigo Cream

Product NDC
69417-120
Requested package NDC
69417-120-03
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 packagepackage69417-12069417-120-03IInactivated by FDA2026-07-31

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
69417-120-03694170120031 TUBE in 1 BOX (69417-120-03) > 10 g in 1 TUBE1 tube2018-08-020000-00-00NoNoCurrent