GLADSKIN ECZEMACT ECZEMA

Product NDC
73105-003
11-digit product format
731050003
Labeler code
73105
Product ID
73105-003_4ba8734b-a8bf-515e-e063-6394a90a892d
Type
HUMAN OTC DRUG
Nonproprietary name
COLLOIDAL OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
Micreos North America, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-05
Substance
OATMEAL
Active strength
.2 mg/mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
GLADSKIN ECZEMACT ECZEMA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui2267204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73105-003-00GLADSKIN ECZEMACT ECZEMA100 mL in 1 BOTTLE, PUMPCREAM1002
73105-003-00GLADSKIN ECZEMACT ECZEMA1 in 1 CARTONCREAM12
73105-003-50GLADSKIN ECZEMACT ECZEMA1 in 1 CARTONCREAM12
73105-003-50GLADSKIN ECZEMACT ECZEMA50 mL in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73105-003GLADSKIN ECZEMACT ECZEMA (COLLOIDAL OATMEAL) CREAM [MICREOS NORTH AMERICA, INC.]1Current NDC, 4 package rows20231007_06f9af75-c5ff-d37b-e063-6394a90a4f6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2267204colloidal oatmeal 0.02 % Topical CreamPSN06f9af75-c5ff-d37b-e063-6394a90a4f6c2
2267204colloidal oatmeal 0.2 MG/ML Topical CreamSCD06f9af75-c5ff-d37b-e063-6394a90a4f6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73105-003-00731050003001 BOTTLE, PUMP in 1 CARTON (73105-003-00) / 100 mL in 1 BOTTLE, PUMP2023-10-05NoNoCurrent
73105-003-50731050003501 BOTTLE, PUMP in 1 CARTON (73105-003-50) / 50 mL in 1 BOTTLE, PUMP2023-10-05NoNoCurrent