Home NDC 55910-653 Eczema Relief
Product NDC 55910-653
11-digit product format 559100653
Labeler code 55910
Product ID 55910-653_4c0f4eee-c522-76ed-e063-6294a90a1dca
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form OINTMENT
Route TOPICAL
Labeler Old East Main Co.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-07
Substance OATMEAL
Active strength 10 mg/11g
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 Eczema Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 10 mg/11g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII 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 55910-653-34 Eczema Relief 226 g in 1 TUBE OINTMENT 226 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-653 ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [OLD EAST MAIN CO] 7 Current NDC, Legacy NDC, 1 package rows 20240925_b2dba027-c295-4a41-8d30-144904e1aa34.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 53 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 PETROLEUM jelly PETROLATUM Universal Distribution Center LLC eaaf95d7-df80-407e-b784-4e42a89d64e5 2024-12-04 Warnings Exact identifier application number: M016 UNIVERSAL COCOA BUTTER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC ec688073-6577-6cf9-e053-2a95a90a631d 2024-12-04 Warnings Exact identifier application number: M016 Burts Bees Rapid Rescue Cold Sore Treatment CAMPHOR, GLYCERIN Burts Bees 9f89735d-205f-4d3e-a1e1-ecc96284fe98 2024-12-03 Warnings Exact identifier application number: M016 Mustela Diaper Rash Sprayable ZINC OXIDE Expanscience Laboratories d/b/a Mustela d9a2aaf6-ab71-97a3-e053-2a95a90a3498 2024-12-02 Warnings Exact identifier application number: M016 Mustela Stelatopia Intense Eczema Relief Skin Protectant COLLOIDAL OATMEAL Expanscience Laboratories d/b/a Mustela e9ac358e-c9bd-7091-e053-2a95a90a4609 2024-12-02 Warnings Exact identifier application number: M016 ZINC OXIDE ZINC OXIDE VIVE HEALTH LLC 284dbf6a-6fa2-742b-e063-6394a90afdfd 2024-12-02 Warnings Exact identifier application number: M016 Readyflush Protect Wipes Fragrance Free DIMETHICONE Medline Industries, LP 743d21bd-c40a-4415-ad97-0d8aa99a8af7 2024-12-02 Warnings Exact identifier application number: M016 Orajel Cold Sore Moisturelock BENZOCAINE Church & Dwight Co., Inc. 3761c7b3-053b-0f50-e054-00144ff88e88 2024-11-26 Warnings Exact identifier application number: M016 Johnsons Baby Care Essentials Gift Set ZINC OXIDE Kenvue Brands LLC ed08b690-f907-6d2f-e053-2a95a90af51c 2024-11-25 Warnings Exact identifier application number: M016 Johnsons First Touch Baby Gift Set ZINC OXIDE Kenvue Brands LLC da5469ea-3330-4f04-e053-2a95a90aff41 2024-11-25 Warnings Exact identifier application number: M016 Lil Drug Store Petroleum Jelly PETROLATUM Lil Drug Store Products, Inc a8a56786-20c3-43c1-a4db-8502ff08e4cb 2024-11-25 Warnings Exact identifier application number: M016 TerrasilMed ONC ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions f0cc9448-c531-4dd1-8f5c-5310e4abe1a9 2024-11-25 Warnings Exact identifier application number: M016 TN Dickinsons Witch Hazel Astringent WITCH HAZEL Dickinson Brands Inc. a9596cf1-8204-447d-90f6-622bf497a7e0 2024-11-25 Warnings Exact identifier application number: M016 PINXAV DAIPER RASH ZINC OXIDE Emjay Laboratories Inc. 14daf592-8edf-4679-9abf-de1b9d0799ff 2024-11-21 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55910-653-34 55910065334 226 g in 1 TUBE (55910-653-34) 226 g 2021-12-07 0000-00-00 No No Current