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 66 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calm and Heal Melting Balm ALLANTOIN The Honest Company, Inc. b08a1bd6-986d-9520-e053-2995a90a865e 2023-12-19 Warnings Exact identifier application number: M016 TopCare Calagesic CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION TOPCO ASSOCIATES LLC 8dced3ea-147b-3d46-e053-2a95a90aa1c0 2023-12-18 Warnings Exact identifier application number: M016 TopCare Calamine CALAMINE 8% AND ZINC OXIDE 8% LOTION TOPCO ASSOCIATES LLC 8dcf134e-0427-0c43-e053-2995a90a7c26 2023-12-18 Warnings Exact identifier application number: M016 HEB Calaclear ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE H E B 5d576794-88d1-484a-e053-2991aa0aa479 2023-12-18 Warnings Exact identifier application number: M016 Publix Calamine Medicated ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Publix 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 2023-12-18 Warnings Exact identifier application number: M016 TopCare Calaclear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION TOPCO ASSOCIATES LLC 8dce8817-b905-4064-e053-2995a90a071e 2023-12-18 Warnings Exact identifier application number: M016 Assured Calamine CALAMINE 8% AND ZINC OXIDE 8% Greenbriar International 9d378cc5-9af0-1389-e053-2995a90a0b96 2023-12-18 Warnings Exact identifier application number: M016 HEB Calagesic ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE H E B 5d579680-6bcb-1161-e053-2991aa0aead1 2023-12-18 Warnings Exact identifier application number: M016 Publix Clear Anti-Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Publix 5d6b905f-ed30-1ab7-e053-2a91aa0a816b 2023-12-18 Warnings Exact identifier application number: M016 Humco Calaclear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Humco Holding Group, Inc. 5fca3a73-6d66-496b-bd33-6e044f9039bc 2023-12-15 Warnings Exact identifier application number: M016 Calamine Phenolated Topical Suspension CALAMINE AND ZINC OXIDE AND PHENOL Humco Holding Group, Inc a3816729-be2b-4b4f-a609-953576cd2e3b 2023-12-15 Warnings Exact identifier application number: M016 Humco Mineral Oil Light MINERAL OIL Humco Holding Group, Inc. 753f35c3-1420-4817-ba63-b737a9c99a1d 2023-12-15 Warnings Exact identifier application number: M016 Humco Witch Hazel WITCH HAZEL Humco Holding Group, Inc. 3cf07016-a129-49ca-8fad-b67dda5aa009 2023-12-15 Warnings Exact identifier application number: M016 Rite Aid Calamine CALAMINE 8% AND ZINC OXIDE 8% Rite Aid Corporation 5df71189-9b36-9dee-e053-2a91aa0a9e49 2023-12-15 Warnings Exact identifier application number: M016 GNP Witch Hazel WITCH HAZEL Amerisource Bergen 45ac839d-215d-4c5f-8ae5-5e111d170061 2023-12-14 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant GLYCERIN L'Oreal USA Products Inc 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief OATMEAL COSMETIQUE ACTIVE PRODUCTION e555de17-9b42-4125-a17b-467bc1d179d7 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief OATMEAL L'Oreal USA Products Inc f7b71606-0044-4729-82e8-4514331806a0 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 GLYCERIN Cosmetique Active Production 01c8a0d5-bcd1-4639-be45-530a226401f0 2023-12-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 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