FDA.reportPublic FDA data

CALENDULA DIAPER RASH CREAM

Product NDC
55946-701
11-digit product format
559460701
Labeler code
55946
Product ID
55946-701_a97efbc6-c4c6-4bd9-a1eb-e20bca6cb9d4
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Weleda, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-07-16
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
55946-701-492019-11-27C16284748780-19855d018-dac9-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM
55946-701-532019-11-27C16284748780-19855d018-dac9-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM
55946-701-542019-11-27C16284748780-19855d018-dac9-cd31-e053-dbdaa90ab51aCALENDULA DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55946-701-49CALENDULA DIAPER RASH CREAM1.5 g in 1 POUCHCREAM1.51
55946-701-53CALENDULA DIAPER RASH CREAM81 g in 1 TUBECREAM811
55946-701-54CALENDULA 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, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
CANANGA OILINACTIVE INGREDIENT8YOY78GNNXCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
CITRUS AURANTIUM LEAFY TWIG OILINACTIVE INGREDIENT5K6H1IMT3DCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
CLARY SAGE OILINACTIVE INGREDIENT87L0D4U3M0CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
GLYCERYL MONOLINOLEATEINACTIVE INGREDIENT4763AXI84LCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
HECTORITEINACTIVE INGREDIENT08X4KI73EZCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
SAGE OILINACTIVE INGREDIENTU27K0H1H2OCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
STYRAX BENZOIN RESININACTIVE INGREDIENTFE663Z8IROCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VCALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55946-701CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]1Legacy NDC, 3 package rows20130717_e5b21fdf-6ba1-4baf-8eb7-b259f4a54ee4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
417994zinc oxide 12 % Topical CreamPSNe5b21fdf-6ba1-4baf-8eb7-b259f4a54ee41
417994zinc oxide 120 MG/ML Topical CreamSCDe5b21fdf-6ba1-4baf-8eb7-b259f4a54ee41
417994zinc oxide 12 % Topical CreamSYe5b21fdf-6ba1-4baf-8eb7-b259f4a54ee41
417994ZNO 120 MG/ML Topical CreamSYe5b21fdf-6ba1-4baf-8eb7-b259f4a54ee41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55946-701-49559460701491.5 g in 1 POUCH1.5 gHistorical
55946-701-535594607015381 g in 1 TUBE81 gHistorical
55946-701-545594607015410.8 g in 1 TUBE10.8 gHistorical