FDA.reportPublic FDA data

Dr. Oberon Diaper Rash Baby Cream

Product NDC
52891-104
11-digit product format
528910104
Labeler code
52891
Product ID
52891-104_ed5b7c1e-1d1f-4633-870c-c87cf3f53c33
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide, dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Oberon Cosmetic Co., Ltd.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-26
Marketing end
0000-00-00
Substance
ZINC OXIDE; DIMETHICONE
Active strength
1 g/15g; g/15g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52891-104-022019-11-27C16284748780-19855e2a2-3d3e-60a7-e053-dbdaa90a05bdDr. Oberon Diaper Rash Baby Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52891-104-01Dr. Oberon Diaper Rash Baby Cream15 g in 1 TUBECREAM151
52891-104-02Dr. Oberon Diaper Rash Baby Cream1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1ODR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1ODR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
AllantoinINACTIVE INGREDIENT344S277G0ZDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
BETULA PLATYPHYLLA VAR. JAPONICA RESININACTIVE INGREDIENT1B33PG6N4KDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
Butylene glycolINACTIVE INGREDIENT3XUS85K0RADR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
CAMELLIA SINENSIS WHOLEINACTIVE INGREDIENTC5M4585ZBZDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEINACTIVE INGREDIENTFJ1H6M2JG9DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1UDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
Cetearyl olivateINACTIVE INGREDIENT58B69Q84JODR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
DIPOTASSIUM GLUCOSE-6-PHOSPHATEINACTIVE INGREDIENTZZW95F4360DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
glyceryl caprylateINACTIVE INGREDIENTTM2TZD4G4ADR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
LIMNANTHES ALBA WHOLEINACTIVE INGREDIENTDKY81513ERDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
MATRICARIA CHAMOMILLA FLOWERING TOP OILINACTIVE INGREDIENTSA8AR2W4ERDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
OLEA EUROPAEA FRUIT VOLATILE OILINACTIVE INGREDIENT8E7358CX1JDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
P-ANISIC ACIDINACTIVE INGREDIENT4SB6Y7DMM3DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
PanthenolINACTIVE INGREDIENTWV9CM0O67ZDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMERINACTIVE INGREDIENT788QAG3W8ADR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
POLYGONUM CUSPIDATUM ROOTINACTIVE INGREDIENT7TRV45YZF7DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
PORTULACA OLERACEA WHOLEINACTIVE INGREDIENTD5J3623SV2DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
PUNICA GRANATUM WHOLEINACTIVE INGREDIENTO2ZTS50U5EDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
ROSMARINUS OFFICINALIS WHOLEINACTIVE INGREDIENTEA3289138MDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
Sorbitan olivateINACTIVE INGREDIENTMDL271E3GRDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
THEOBROMA CACAO WHOLEINACTIVE INGREDIENTEB048G1S9JDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
TrehaloseINACTIVE INGREDIENTB8WCK70T7IDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
WaterINACTIVE INGREDIENT059QF0KO0RDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VDR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52891-104DR. OBERON DIAPER RASH BABY CREAM (ZINC OXIDE, DIMETHICONE) CREAM [OBERON COSMETIC CO., LTD.]1Legacy NDC, 2 package rows20140627_8e32f17b-0e1a-4165-a20c-44d99516b235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1541229zinc oxide 5 % / dimethicone 1 % Topical CreamPSN8e32f17b-0e1a-4165-a20c-44d99516b2351
1541229dimethicone 10 MG/ML / zinc oxide 50 MG/ML Topical CreamSCD8e32f17b-0e1a-4165-a20c-44d99516b2351
1541229dimethicone 1 % / zinc oxide 5 % Topical CreamSY8e32f17b-0e1a-4165-a20c-44d99516b2351
1541229dimethicone 10 MG/ML / ZNO 50 MG/ML Topical CreamSY8e32f17b-0e1a-4165-a20c-44d99516b2351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52891-104-015289101040115 g in 1 TUBE15 gHistorical
52891-104-02528910104021 in 1 CARTONHistorical