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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 69417-140 | 69417-140-03 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|
| OATMEAL | 20 mg/mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69417-140-03 | THE INDIGO CALMING | 10 mL in 1 JAR | CREAM | 10 | 5 | |
| 69417-140-03 | THE INDIGO CALMING | 1 in 1 BOX | CREAM | 1 | 5 | |
| 69417-140-04 | THE INDIGO CALMING | 1 in 1 BOX | CREAM | 1 | 5 | |
| 69417-140-04 | THE INDIGO CALMING | 15 mL in 1 JAR | CREAM | 15 | 5 | |
| 69417-140-17 | THE INDIGO CALMING | 1 in 1 BOX | CREAM | 1 | 5 | |
| 69417-140-17 | THE INDIGO CALMING | 50 mL in 1 JAR | CREAM | 50 | 5 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fc9eecd-fd25-827c-e063-6394a90a26a5 | 2025-03-26 | Warnings | M016 |
| Cocoa Butter Petroleum Jelly | WHITE PETROLATUM JELLY | WALGREENS | 1fcc9626-6058-e9b3-e063-6394a90ab525 | 2025-03-26 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 313b08e2-d764-96da-e063-6294a90ab705 | 2025-03-25 | Warnings | M016 |
| Eczema Cream | ECZEMA CREAM | Kyte Baby LLC | 30c943aa-d9dc-5c16-e063-6294a90a3c58 | 2025-03-20 | Warnings | M016 |
| Koala Kubs Diaper Rash Cream | DIAPER RASH CREAM | Melaleuca, Inc. | c6b3b0dd-22a8-16f7-e053-2a95a90a51ea | 2025-03-20 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Skin Protectant Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 2b6b8342-878d-4588-8b24-6746d35d319d | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b20bd5-3b4f-8cc7-e063-6394a90a9106 | 2025-03-19 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 30b2744d-fb59-f383-e063-6294a90abd2a | 2025-03-19 | Warnings | M016 |
| Dr. Butler Hemorrhoid and Perineal | MINERAL OIL 59.8%,PETROLATUM 36% | Beyond Health P.A. | d17b6f16-6893-ce0a-e053-2a95a90aa23a | 2025-03-19 | Warnings | M016 |
| Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream | DIMETHICONE, WHITE PETROLATUM | Chattem, Inc. | b951d1cb-b81e-4d7f-9a67-8405daa89667 | 2025-03-19 | Warnings | M016 |
| Gold Bond Eczema Relief Medicated Hand Cream | COLLOIDAL OATMEAL | Chattem, Inc. | 27457bc5-3edc-4c8b-b8a2-eaf09b511cf8 | 2025-03-19 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 30a977c3-6862-670e-e063-6294a90aeb2f | 2025-03-18 | Warnings | M016 |
| YVTYVT Copper Peptides Face Serum | COPPER TRIPEPTIDE-1 | Beijing JUNGE Technology Co., Ltd. | 306f2d48-43b8-359a-e063-6394a90a06dc | 2025-03-16 | Boxed warning, Warnings | M016 |
| Dr Talbots Cooling Perineal Pad | WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE | Talbot's Pharmaceuticals family Products, LLC. | 242277e2-ff26-ad4e-e063-6394a90ab317 | 2025-03-14 | Warnings | M016 |
| RID Poison Ivy Rash Relief | CALAMINE AND ZINC OXIDE | Oystershell Consumer Health Inc. | 36c3af9a-2646-4427-e063-6394a90a2c5e | 2025-03-13 | Warnings | M016 |
| Aavini Double Layer Brightening Spot Correcting Essence Oil | AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL | Qingyuan Moksha Biotechnology Co., Ltd. | 2ff89a13-3969-2df1-e063-6394a90ac0d3 | 2025-03-10 | Warnings | M016 |
| 5% Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3008bbeb-abba-5cdb-e063-6294a90ae483 | 2025-03-10 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 2fc4745c-fac9-7861-e063-6294a90a3f14 | 2025-03-07 | Warnings | M016 |
| AD Skin Protectant | AD SKIN PROTECTANT | WellSpring Pharmaceutical Corporation | d26f1312-2e1b-4106-bc48-a336d4e034ad | 2025-03-07 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Nighttime Balm | OATMEAL | Kenvue Brands LLC | 04d90e45-c2ee-4122-b919-a0eb6d11b59a | 2025-03-04 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1189915 | colloidal oatmeal 2 % Topical Cream | PSN | f2b9a49d-e91f-416d-a031-15bbde005d2f | 5 |
| 1189915 | colloidal oatmeal 20 MG/ML Topical Cream | SCD | f2b9a49d-e91f-416d-a031-15bbde005d2f | 5 |
| 1189915 | colloidal oatmeal 2 % Topical Cream | SY | f2b9a49d-e91f-416d-a031-15bbde005d2f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69417-140-03 | 69417014003 | 10 mL in 1 JAR | 10 ml | Historical | |||
| 69417-140-04 | 69417014004 | 1 JAR in 1 BOX (69417-140-04) / 15 mL in 1 JAR | 1 jar | 2025-03-31 | No | No | Current |
| 69417-140-17 | 69417014017 | 1 JAR in 1 BOX (69417-140-17) / 50 mL in 1 JAR | 1 jar | 2023-04-26 | No | No | Current |