Cetaphil Eczema Soothing Moisturizer

Product NDC
0299-4128
11-digit product format
002994128
Labeler code
0299
Product ID
0299-4128_ff608523-49d2-49d5-8b05-ef343d774052
Type
HUMAN OTC DRUG
Nonproprietary name
colloidal oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
OATMEAL
Active strength
1 g/100mL
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0299-41280299-4128-00DDiscontinued by firm2026-10-16

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
Cetaphil Eczema Soothing Moisturizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4128-00Cetaphil Eczema Soothing Moisturizer296 mL in 1 BOTTLE, PUMPLOTION2965
0299-4128-05Cetaphil Eczema Soothing Moisturizer29 mL in 1 BOTTLELOTION295
0299-4128-10Cetaphil Eczema Soothing Moisturizer473 mL in 1 BOTTLE, PUMPLOTION4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4128CETAPHIL ECZEMA SOOTHING MOISTURIZER (COLLOIDAL OATMEAL) LOTION [GALDERMA LABORATORIES, L.P.]5Current NDC, Legacy NDC, 3 package rows20240509_0d01c3fb-d420-484d-aae1-33234c9e383e.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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
application number: M016
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
application number: M016
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
application number: M016
VITAMIN A and DVITAMIN A AND DALLIED TRADE LINK LLC26d426c3-4dfb-c984-e063-6394a90a37932024-11-13WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure ProgramALUMINUM ACETATEZO Skin Health, Inc.9786acc8-06ae-4f2b-9602-b7e8c3baeca52024-11-12WarningsExact identifier
application number: M016
DUKAL WHITE PETROLATUMPETROLATUMDukal LLC0c6474ed-2343-d5f2-e063-6394a90a30b32024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Health2fead2d8-b645-4d45-8e5b-b4f1da4e5a252024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Healthc6926594-ad4e-4937-bda2-9311219a88812024-11-12WarningsExact identifier
application number: M016
CVS Zinc OxideZINC OXIDECVS Healthd67533b1-ae3f-4c9a-a6c9-a742290c90e92024-11-11WarningsExact identifier
application number: M016
CVS Eczema Relief Skin ProtectantOATMEALCVS Health3cf25c43-592f-41cb-aa0b-a82f4e7faf3d2024-11-11WarningsExact identifier
application number: M016
DGH Advanced Formula Scar Skin ProtectantALLANTOINDolgencorp Inc950dcffd-d2c3-4ca7-8a15-7cb1016ca3642024-11-08WarningsExact identifier
application number: M016
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
application number: M016
SUPER SENSITIVE DIAPER RASHZINC OXIDEORGANIC & SUSTAINABLE BEAUTYb0de2a9b-7854-4caf-b7ff-632c1d4a382e2024-11-08WarningsExact identifier
application number: M016
DoveDERMASERIES ECZEMA RELIEF SOOTHING BODY LOTIONConopco, Inc. d/b/a/ Unileverbcfb12ea-304e-7d8c-e053-2a95a90af6062024-11-07WarningsExact identifier
application number: M016
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
application number: M016
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
application number: M016
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240464colloidal oatmeal 1 % Topical LotionPSN0d01c3fb-d420-484d-aae1-33234c9e383e5
240464colloidal oatmeal 10 MG/ML Topical LotionSCD0d01c3fb-d420-484d-aae1-33234c9e383e5
240464colloidal oatmeal 1 % Topical LotionSY0d01c3fb-d420-484d-aae1-33234c9e383e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-4128-0000299412800296 mL in 1 BOTTLE, PUMP (0299-4128-00) 296 ml2022-05-010000-00-00NoNoCurrent
0299-4128-050029941280529 mL in 1 BOTTLE (0299-4128-05) 29 ml2022-05-010000-00-00NoNoCurrent
0299-4128-1000299412810473 mL in 1 BOTTLE, PUMP (0299-4128-10) 473 ml2024-05-01NoNoCurrent