FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Therapeutic Hand

Product NDC
49967-925
11-digit product format
499670925
Labeler code
49967
Product ID
49967-925_26ac7b9e-562d-48c3-a4dc-838a751e975e
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-12
Substance
DIMETHICONE
Active strength
10 mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-92549967-925-01DDiscontinued by firm2026-10-12
excluded packagepackage49967-92549967-925-02DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549967-925-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549967-925-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649967-925-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649967-925-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149967-925-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149967-925-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849967-925-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849967-925-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149967-925-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149967-925-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049967-925-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049967-925-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149967-925-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149967-925-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049967-925-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049967-925-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049967-925-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049967-925-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849967-925-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849967-925-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349967-925-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349967-925-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949967-925-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949967-925-01557ba5c1ecfa…9c80585c8c6e…

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
CeraVe Developed with Dermatologists Therapeutic Hand
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200010Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fe49112-4180-415c-a380-768a8d6b2185Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-925-01CeraVe Developed with Dermatologists Therapeutic Hand85 g in 1 BOTTLECREAM855
49967-925-01CeraVe Developed with Dermatologists Therapeutic Hand1 in 1 CARTONCREAM15
49967-925-02CeraVe Developed with Dermatologists Therapeutic Hand5 g in 1 TUBECREAM55
49967-925-03CeraVe Developed with Dermatologists Therapeutic Hand85 g in 1 TUBECREAM855
49967-925-03CeraVe Developed with Dermatologists Therapeutic Hand1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-925CERAVE DEVELOPED WITH DERMATOLOGISTS THERAPEUTIC HAND (DIMETHICONE) CREAM [L'OREAL USA PRODUCTS INC]5Current NDC, Legacy NDC, 5 package rows20231229_7fe49112-4180-415c-a380-768a8d6b2185.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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200010dimethicone 1 % Topical CreamPSN7fe49112-4180-415c-a380-768a8d6b21855
200010dimethicone 10 MG/ML Topical CreamSCD7fe49112-4180-415c-a380-768a8d6b21855
200010dimethicone 1 % Topical CreamSY7fe49112-4180-415c-a380-768a8d6b21855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-925-01499670925011 BOTTLE in 1 CARTON (49967-925-01) > 85 g in 1 BOTTLE1 bottle2017-12-120000-00-00NoNoCurrent
49967-925-02499670925025 g in 1 TUBE (49967-925-02) 5 g2017-12-120000-00-00NoNoCurrent
49967-925-03499670925031 TUBE in 1 CARTON (49967-925-03) / 85 g in 1 TUBE1 tube2017-12-120000-00-00NoNoCurrent