Home NDC 65197-406 AD Medicated Rash
Product NDC 65197-406
11-digit product format 651970406
Labeler code 65197
Product ID 65197-406_8fd6a4a0-06b0-4006-b00c-b910dfeb6d7b
Type HUMAN OTC DRUG
Nonproprietary name AD Medicated Rash
Dosage form OINTMENT
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-15
Substance MINERAL OIL; OATMEAL
Active strength 30; 2 g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AD Medicated Rash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 30 g/100g OATMEAL 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2710836 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-406-15 AD Medicated Rash 42.5 g in 1 TUBE OINTMENT 42.5 5 65197-406-15 AD Medicated Rash 1 in 1 BOX OINTMENT 1 5 65197-406-52 AD Medicated Rash 431 g in 1 JAR OINTMENT 431 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-406 AD MEDICATED RASH OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION] 5 Current NDC, 3 package rows 20250427_aac345bf-ea66-4f5b-a497-c24ea72f93ea.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 51 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016 Blistex Ivarest Poison Ivy Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Blistex Inc. e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a 2024-12-11 Warnings Exact identifier application number: M016 Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE Blistex Inc 11c0e084-dc40-4969-a176-3af4116d6f27 2024-12-10 Warnings Exact identifier application number: M016 BOA VIDA Recovery Creme DIMETHICONE Central Solutions Inc bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Canopy DIMETHICONE Central Solutions Inc 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf 2024-12-09 Warnings Exact identifier application number: M016 DermaCen Skin Protectant ZINC OXIDE Central Solutions Inc 990c3a65-bca5-1f0d-e053-2995a90aa7ae 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Calvida ZINC OXIDE Central Solutions Inc 48eb2031-bc80-45d5-b8b3-cc08fcab64f1 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Cleansing DIMETHICONE Central Solutions Inc 0b456b20-ab06-4adf-b5f0-1693d33979df 2024-12-09 Warnings Exact identifier application number: M016 SOOTHE Sensitive Skin Treatment ALLANTOIN, DIMETHICONE Rodan & Fields 2bd8cac4-5f40-4d04-91f2-3ea8a138033b 2024-12-09 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment COLLOIDAL OATMEAL Kenvue Brands LLC f67e528a-b822-3f7a-e053-2995a90ae733 2024-12-06 Warnings Exact identifier application number: M016 Humphreys Maravilla WITCH HAZEL Humphreys Pharmacal, Incorporated 7d403bf4-8a0d-4337-8e81-1149cd0ae1dc 2024-12-06 Warnings Exact identifier application number: M016 Skin Soothing Cream COLLOIDAL OATMEAL Allure Labs Inc 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3 2024-12-05 Warnings Exact identifier application number: M016 Skin Soothing Cream - Nut Free COLLOIDAL OATMEAL Allure Labs b5eb48a5-e884-3bf6-e053-2a95a90abb97 2024-12-05 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-406-15 65197040615 1 TUBE in 1 BOX (65197-406-15) / 42.5 g in 1 TUBE 1 tube 2025-01-15 No No Current 65197-406-52 65197040652 431 g in 1 JAR (65197-406-52) 431 g 2025-04-30 No No Current