Zinc Oxide and Dimethicone

Product NDC
50382-012
11-digit product format
503820012
Labeler code
50382
Product ID
50382-012_c824ad2f-391a-464f-a444-7b7d43d75038
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-08
Marketing end
0000-00-00
Substance
ZINC OXIDE; DIMETHICONE
Active strength
200 mg/g; mg/g
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50382-012-012019-11-27C16284748780-19855d018-d706-cd31-e053-dbdaa90ab51aGalshield Zinc Oxide / Dimethicone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-012-01Zinc Oxide and Dimethiconewith Dimethicone113.4 g in 1 TUBECREAM113.41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
CETETH-10INACTIVE INGREDIENTLF9X1PN3XJZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
LANOLININACTIVE INGREDIENT7EV65EAW6HZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9NZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
VITAMIN AINACTIVE INGREDIENT81G40H8B0TZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0RZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-012ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE (ZINC OXIDE AND DIMETHICONE) CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1Legacy NDC, 1 package rows20130809_987f3500-e7b4-45bc-bb29-8b5b59b9bb4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043605dimethicone 1.8 % / zinc oxide 20 % Topical CreamPSN987f3500-e7b4-45bc-bb29-8b5b59b9bb4b1
1043605dimethicone 18 MG/ML / zinc oxide 200 MG/ML Topical CreamSCD987f3500-e7b4-45bc-bb29-8b5b59b9bb4b1
1043605dimethicone 1.8 % / zinc oxide 20 % Topical CreamSY987f3500-e7b4-45bc-bb29-8b5b59b9bb4b1
1043605dimethicone 18 MG/ML / ZNO 200 MG/ML Topical CreamSY987f3500-e7b4-45bc-bb29-8b5b59b9bb4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50382-012-0150382001201113.4 g in 1 TUBE113.4 gHistorical