Dr. OBERON MOMS CARE OIL

Product NDC
52891-101
11-digit product format
528910101
Labeler code
52891
Product ID
52891-101_45a35ea6-9af4-4375-b0fe-b36ed00a3a74
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone
Dosage form
OIL
Route
TOPICAL
Labeler
Oberon Cosmetic Co., Ltd.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
2 1/150mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52891-101IInactivated by FDA2026-10-05
excluded packagepackage52891-10152891-101-02IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52891-101-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52891-101-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52891-101-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52891-101-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52891-101-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52891-101-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52891-101-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52891-101-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52891-101-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52891-101-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52891-101-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52891-101-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52891-101-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52891-101-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52891-101-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52891-101-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52891-101-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52891-101-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52891-101-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52891-101-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52891-101-029bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52891-101-02110d247fa046…a55b01930146…

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
52891-101-022019-11-27C16284748780-19855e2a2-32cd-60a7-e053-dbdaa90a05bdDr. OBERON MOM'S CARE OIL LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52891-101-01Dr. OBERON MOMS CARE OIL150 mL in 1 BOTTLE, PUMPOIL1501
52891-101-02Dr. OBERON MOMS CARE OIL1 in 1 CARTONOIL11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1ODR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ODR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
ALOEINACTIVE INGREDIENTV5VD430YW9DR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RADR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9DR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
dipropylene glycolINACTIVE INGREDIENTE107L85C40DR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A065DR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
HELIANTHUS ANNUUS SEED WAXINACTIVE INGREDIENT42DG15CHXVDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
MOMORDICA CHARANTIA FRUITINACTIVE INGREDIENTUA63Y8U89UDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
OLEA EUROPAEA FRUIT VOLATILE OILINACTIVE INGREDIENT8E7358CX1JDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ADR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1
waterINACTIVE INGREDIENT059QF0KO0RDR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52891-101DR. OBERON MOMS CARE OIL (DIMETHICONE) OIL [OBERON COSMETIC CO., LTD.]1Legacy NDC, 2 package rows20140612_d4a4e200-88e8-4f59-8436-62e05d4bfcd3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52891-101-0152891010101150 mL in 1 BOTTLE, PUMP150 mlHistorical
52891-101-02528910101021 in 1 CARTONHistorical