FDA.reportPublic FDA data

Theraplex

Product NDC
62917-350
Requested package NDC
62917-350-06
11-digit product format
629170350
Labeler code
62917
Product ID
62917-350_9d6e2374-7834-46e5-a368-2f5918706ebf
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
The Theraplex Company, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-01
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage62917-35062917-350-06IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62917-350-012021-07-23C16284748780-1c7ccaba7-20ca-fd44-e053-dadaa90aa01bTheraplex
62917-350-062021-07-23C16284748780-1c7ccaba7-20ca-fd44-e053-dadaa90aa01bTheraplex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62917-350-01Theraplex Eczema Therapy Moisturizing skin protectant128 g in 1 TUBELOTION1285
62917-350-06Theraplex Eczema Therapy Moisturizing skin protectant170.1 g in 1 JARLOTION170.15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YTHERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]3
OATMEALACTIVE MOIETY8PI54V663YTHERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]3
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZTHERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]3
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYTHERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTHERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62917-350THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT (COLLOIDAL OATMEAL) LOTION [THE THERAPLEX COMPANY, LLC]5Legacy NDC, 2 package rows20180222_47b50665-1909-411f-b6e0-d24602811c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240464colloidal oatmeal 1 % Topical LotionPSN47b50665-1909-411f-b6e0-d24602811c995
1492753theraplex Eczema Therapy 1 % Topical LotionPSN47b50665-1909-411f-b6e0-d24602811c995
1492753colloidal oatmeal 10 MG/ML Topical Lotion [Theraplex Eczema Therapy]SBD47b50665-1909-411f-b6e0-d24602811c995
240464colloidal oatmeal 10 MG/ML Topical LotionSCD47b50665-1909-411f-b6e0-d24602811c995
240464colloidal oatmeal 1 % Topical LotionSY47b50665-1909-411f-b6e0-d24602811c995
1492753Theraplex Eczema Therapy 1 % Topical LotionSY47b50665-1909-411f-b6e0-d24602811c995
1492753Theraplex Eczema Therapy 10 MG/ML Topical LotionSY47b50665-1909-411f-b6e0-d24602811c995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62917-350-0662917035006170.1 g in 1 JAR (62917-350-06) 170.1 g2018-01-230000-00-00NoNoCurrent