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 firm2026-10-16
excluded packagepackage49967-92549967-925-02DDiscontinued by firm2026-10-16

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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Medicated Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
application number: M016
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
application number: M016
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
application number: M016
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
application number: M016
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact 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