FDA.reportPublic FDA data

CALENDULA DIAPER RASH CREAM

Product NDC
0164-2189
11-digit product format
001642189
Labeler code
0164
Product ID
0164-2189_5f0f7acc-f134-43bb-9797-48e73a35e64f
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
2013-06-27
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
12 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0164-2189-492019-11-27C16284748780-19855d018-d91c-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM
0164-2189-532019-11-27C16284748780-19855d018-d91c-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM
0164-2189-542019-11-27C16284748780-19855d018-d91c-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0164-2189-49CALENDULA DIAPER RASH CREAM1.5 g in 1 POUCHCREAM1.51
0164-2189-53CALENDULA DIAPER RASH CREAM81 g in 1 TUBECREAM811
0164-2189-54CALENDULA DIAPER RASH CREAM10.8 g in 1 TUBECREAM10.81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
CANANGA OILINACTIVE INGREDIENT8YOY78GNNXCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
CITRUS AURANTIUM LEAFY TWIG OILINACTIVE INGREDIENT5K6H1IMT3DCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
CLARY SAGE OILINACTIVE INGREDIENT87L0D4U3M0CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
GLYCERYL MONOLINOLEATEINACTIVE INGREDIENT4763AXI84LCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
HECTORITEINACTIVE INGREDIENT08X4KI73EZCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SAGE OILINACTIVE INGREDIENTU27K0H1H2OCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
STYRAX BENZOIN RESININACTIVE INGREDIENTFE663Z8IROCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
WATERINACTIVE INGREDIENT059QF0KO0RCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VCALENDULA 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
0164-2189CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA A.G. SCHWÄBISCH GMÜND, ZWEIGNIEDERLASSUNG DER WELED]1Legacy NDC, 3 package rows20130628_4ca9ff2c-c6c6-4838-bff6-3a431e904246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417994zinc oxide 12 % Topical CreamPSN4ca9ff2c-c6c6-4838-bff6-3a431e9042461
417994zinc oxide 120 MG/ML Topical CreamSCD4ca9ff2c-c6c6-4838-bff6-3a431e9042461
417994zinc oxide 12 % Topical CreamSY4ca9ff2c-c6c6-4838-bff6-3a431e9042461
417994ZNO 120 MG/ML Topical CreamSY4ca9ff2c-c6c6-4838-bff6-3a431e9042461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0164-2189-49001642189491.5 g in 1 POUCH1.5 gHistorical
0164-2189-530016421895381 g in 1 TUBE81 gHistorical
0164-2189-540016421895410.8 g in 1 TUBE10.8 gHistorical