ad treat diaper rash cream with dimethicone and zinc oxide

Generic: ad treat diaper rash cream with dimethicone and zinc oxide

Labeler: wellspring pharmaceutical corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ad treat diaper rash cream with dimethicone and zinc oxide
Generic Name ad treat diaper rash cream with dimethicone and zinc oxide
Labeler wellspring pharmaceutical corporation
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 1 g/100g, zinc oxide 10 g/100g

Manufacturer
WellSpring Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 65197-402
Product ID 65197-402_82632391-efd7-45f8-bd24-77ce6c407f9d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-09-19

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65197402
Hyphenated Format 65197-402

Supplemental Identifiers

RxCUI
686403
UNII
92RU3N3Y1O SOI2LOH54Z
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ad treat diaper rash cream with dimethicone and zinc oxide (source: ndc)
Generic Name ad treat diaper rash cream with dimethicone and zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
  • 10 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (65197-402-00) / 113 g in 1 TUBE
  • 454 g in 1 JAR (65197-402-16)
source: ndc

Packages (2)

65197-402-00 1 TUBE in 1 BOX (65197-402-00) / 113 g in 1 TUBE 65197-402-16 454 g in 1 JAR (65197-402-16)

Ingredients (2)

dimethicone (1 g/100g) zinc oxide (10 g/100g)

Linked Drug Pages (1)

AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "82632391-efd7-45f8-bd24-77ce6c407f9d", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "SOI2LOH54Z"], "rxcui": ["686403"], "spl_set_id": ["dc794a75-cd69-4658-b164-4182a86d90df"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["WellSpring Pharmaceutical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (65197-402-00)  / 113 g in 1 TUBE", "package_ndc": "65197-402-00", "marketing_start_date": "20230919"}, {"sample": false, "description": "454 g in 1 JAR (65197-402-16)", "package_ndc": "65197-402-16", "marketing_start_date": "20250615"}], "brand_name": "AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide", "product_id": "65197-402_82632391-efd7-45f8-bd24-77ce6c407f9d", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "65197-402", "generic_name": "AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide", "labeler_name": "WellSpring Pharmaceutical Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AD Treat Diaper Rash Cream with Dimethicone and Zinc Oxide", "active_ingredients": [{"name": "DIMETHICONE", "strength": "1 g/100g"}, {"name": "ZINC OXIDE", "strength": "10 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230919", "listing_expiration_date": "20261231"}