FDA.reportPublic FDA data

AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide

Product NDC
65197-402
11-digit product format
651970402
Labeler code
65197
Product ID
65197-402_82632391-efd7-45f8-bd24-77ce6c407f9d
Type
HUMAN OTC DRUG
Nonproprietary name
AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-19
Substance
DIMETHICONE; ZINC OXIDE
Active strength
1; 10 g/100g; g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1 g/100g
ZINC OXIDE10 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, SOI2LOH54Z
Rxcui686403

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-402-00AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide1 in 1 BOXCREAM17
65197-402-00AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide113 g in 1 TUBECREAM1137
65197-402-16AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide454 g in 1 JARCREAM4547

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-402-00GM - Gram65197-4020900c8fa-09df-4a40-94dd-79e707ef4cf912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-402AD TREAT DIAPER RASH CREAM WITH DIMETHICONE AND ZINC OXIDE CREAM [WELLSPRING PHARMACEUTICAL CORPORATION]6Current NDC, 3 package rows20250110_dc794a75-cd69-4658-b164-4182a86d90df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686403dimethicone 1 % / zinc oxide 10 % Topical CreamPSNdc794a75-cd69-4658-b164-4182a86d90df7
686403dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical CreamSCDdc794a75-cd69-4658-b164-4182a86d90df7
686403dimethicone 1 % / zinc oxide 10 % Topical CreamSYdc794a75-cd69-4658-b164-4182a86d90df7
686403dimethicone 10 MG/ML / ZNO 100 MG/ML Topical CreamSYdc794a75-cd69-4658-b164-4182a86d90df7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-402-00651970402001 TUBE in 1 BOX (65197-402-00) / 113 g in 1 TUBE1 tube2023-09-19NoNoHistorical
65197-402-1665197040216454 g in 1 JAR (65197-402-16) 454 g2025-06-15NoNoHistorical