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 6 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier application number: M016 MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier application number: M016 Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 3e61191a-e0fa-3477-e063-6294a90a7d19 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 459a90b8-7d52-ef70-e063-6394a90ac1d0 2026-07-14 Warnings Exact identifier application number: M016 Mederma for Kids ALLANTOIN L. Perrigo Company ed4ff435-9819-46d3-9375-914712943f77 2026-07-14 Warnings Exact identifier application number: M016 Baby 3-in-1 Diaper Rash BABY 3-IN-1 DIAPER RASH Walgreens 5632dde2-f59d-3a45-e063-6394a90a1a24 2026-07-09 Warnings Exact identifier application number: M016 Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier application number: M016 Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Exact identifier application number: M016 SOHEJU Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 560089ff-3361-90b7-e063-6294a90ada42 2026-07-09 Warnings Exact identifier application number: M016 Bee Venom Psoriasis Wart Caring Cream GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 563a423c-e9dd-1cab-e063-6294a90a8c6a 2026-07-09 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson Medical-Surgical Inc. 46df52c8-0cbf-213e-e054-00144ff88e88 2026-07-08 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson 5abe1b34-f71b-2a90-e053-2991aa0aded6 2026-07-08 Warnings Exact identifier application number: M016 Walgreens Baby Healing Balm PETROLATUM Walgreens 561c1e1e-e896-d6e9-e063-6394a90ac0e7 2026-07-08 Warnings Exact identifier application number: M016 AD Overnight Healing AD OVERNIGHT HEALING WellSpring Pharmaceutical Corporation 57c29db6-da0c-4b28-86c0-6ac1b7122428 2026-07-07 Warnings Exact identifier application number: M016 EczeNourish Eczema and Psoriasis Soothing Oat COLLOIDAL OATMEAL Vanguard Soap, LLC 55f7137f-c5a5-f2ce-e063-6394a90a5280 2026-07-07 Warnings Exact identifier application number: M016 FDS intimate Whole Body Medicated Chafing FDS INTIMATE WHOLE BODY MEDICATED CHAFING WellSpring Pharmaceutical Corporation ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c 2026-07-07 Warnings Exact identifier application number: M016 AD First Aid Multipurpose AD FIRST AID MULTIPURPOSE WellSpring Pharmaceutical Corporation 999989d8-21c2-4380-b4c1-e5421189f6ed 2026-07-07 Warnings Exact identifier application number: M016 AD Anti-Chafing AD ANTI-CHAFING WellSpring Pharmaceutical Corporation d272ab4a-eb18-4f64-b925-fccf637dbb02 2026-07-06 Warnings Exact identifier application number: M016 ECZEMA NOURISH MEDICATED CLEANSING BAR COLLOIDAL OATMEAL SKIN PROTECTANT Vanguard Soap, LLC 55f865dc-d88e-fe2f-e063-6294a90aa7d3 2026-07-06 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