FDA.reportPublic FDA data

WHITE MALLOW DIAPER RASH CREAM

Product NDC
0164-2207
11-digit product format
001642207
Labeler code
0164
Product ID
0164-2207_436b3d70-1250-4ad2-a8d9-ead21ada6ec2
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Weleda A.G. Schw
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-22
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
14 g/100g
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0164-2207-652019-11-27C16284748780-19855e2a2-44af-60a7-e053-dbdaa90a05bdWHITE MALLOW DIAPER RASH CREAM
0164-2207-662019-11-27C16284748780-19855e2a2-44af-60a7-e053-dbdaa90a05bdWHITE MALLOW DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0164-2207-65WHITE MALLOW DIAPER RASH CREAM55.1 g in 1 TUBECREAM55.11
0164-2207-66WHITE MALLOW DIAPER RASH CREAM3 g in 1 POUCHCREAM31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9WHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47HWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
BORAGE OILINACTIVE INGREDIENTF8XAG1755SWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
GLYCERYL CAPRYLATEINACTIVE INGREDIENTTM2TZD4G4AWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
LANOLININACTIVE INGREDIENT7EV65EAW6HWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SODIUM CAPROYL LACTYLATEINACTIVE INGREDIENT87WR3BHC09WHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
VIOLA TRICOLORINACTIVE INGREDIENT9Q24RAI43VWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
WATERINACTIVE INGREDIENT059QF0KO0RWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VWHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0164-2207WHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1Legacy NDC, 2 package rows20140823_1bc9f5e8-5e3e-43af-9e07-a8c757cd4d71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546589zinc oxide 14 % Topical CreamPSN1bc9f5e8-5e3e-43af-9e07-a8c757cd4d711
1546589zinc oxide 140 MG/ML Topical CreamSCD1bc9f5e8-5e3e-43af-9e07-a8c757cd4d711
1546589zinc oxide 14 % Topical CreamSY1bc9f5e8-5e3e-43af-9e07-a8c757cd4d711
1546589ZNO 140 MG/ML Topical CreamSY1bc9f5e8-5e3e-43af-9e07-a8c757cd4d711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0164-2207-650016422076555.1 g in 1 TUBE55.1 gHistorical
0164-2207-66001642207663 g in 1 POUCH3 gHistorical