FDA.reportPublic FDA data

THE INDIGO CALMING

Product NDC
69417-140
11-digit product format
694170140
Labeler code
69417
Product ID
69417-140_5c3d4401-2bbd-2b0d-e063-6394a90acc80
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
TATCHA INC.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-26
Substance
OATMEAL
Active strength
20 mg/mL
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69417-14069417-140-03DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
THE INDIGO CALMING
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL20 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69417-140-03THE INDIGO CALMING10 mL in 1 JARCREAM105
69417-140-03THE INDIGO CALMING1 in 1 BOXCREAM15
69417-140-04THE INDIGO CALMING1 in 1 BOXCREAM15
69417-140-04THE INDIGO CALMING15 mL in 1 JARCREAM155
69417-140-17THE INDIGO CALMING1 in 1 BOXCREAM15
69417-140-17THE INDIGO CALMING50 mL in 1 JARCREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69417-140THE INDIGO CALMING (COLLOIDAL OATMEAL) CREAM [TATCHA INC.]3Current NDC, 6 package rows20250406_f2b9a49d-e91f-416d-a031-15bbde005d2f.zip

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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42762471-e5cd-505e-e063-6294a90afb7d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSNf2b9a49d-e91f-416d-a031-15bbde005d2f5
1189915colloidal oatmeal 20 MG/ML Topical CreamSCDf2b9a49d-e91f-416d-a031-15bbde005d2f5
1189915colloidal oatmeal 2 % Topical CreamSYf2b9a49d-e91f-416d-a031-15bbde005d2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69417-140-036941701400310 mL in 1 JAR10 mlHistorical
69417-140-04694170140041 JAR in 1 BOX (69417-140-04) / 15 mL in 1 JAR1 jar2025-03-31NoNoCurrent
69417-140-17694170140171 JAR in 1 BOX (69417-140-17) / 50 mL in 1 JAR1 jar2023-04-26NoNoCurrent