Home NDC 57337-138 XtraCare Oatmeal Daily Moisturizing
Product NDC 57337-138
11-digit product format 573370138
Labeler code 57337
Product ID 57337-138_2e12de28-f85b-9518-e063-6394a90ae58f
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Rejoice International Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-19
Substance DIMETHICONE
Active strength 1.3 g/100g
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57337-138-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-138-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-138-01 0efc9e666f02…f202fb6c5f17…
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 XtraCare Oatmeal Daily Moisturizing
Brand name suffix 8 oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1.3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891710 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-138-01 XtraCare Oatmeal Daily Moisturizing8 oz 227 g in 1 BOTTLE, PUMP LOTION 227 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-138 XTRACARE OATMEAL DAILY MOISTURIZING 8 OZ (DIMETHICONE) LOTION [REJOICE INTERNATIONAL INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250216_c055d5fb-7398-26e4-e053-2995a90acd41.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 62 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Healing PETROLATUM Galderma Laboratories, L.P. e996db17-bd4d-4b06-bb9a-983dbdec8022 2024-03-13 Warnings Exact identifier application number: M016 Diaper Rash Cream 2oz ZINC OXIDE Rejoice International Corp. 130a06a7-3360-afed-e063-6294a90ac19f 2024-03-06 Warnings Exact identifier application number: M016 mama bear DIAPER RASH Skin Protectant LANOLIN AND PETROLATUM AMAZON.COM SERVICES LLC cda9ca47-b668-4a65-908d-80b9a6515bd7 2024-03-06 Warnings Exact identifier application number: M016 Dermachange Scar ALLANTOIN Private Label Beauty and Wellness 12eed473-10d6-49c8-e063-6394a90afb63 2024-03-05 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched PETROLEUM Rejoice International 580d76ee-ea89-426e-bd25-7a58481e9795 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Vitamin E enriched PETROLATUM Rejoice International 2c382a50-93d2-4d28-b7a4-1702b20b7139 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Foaming Facial Cleanser TRICLOSAN Rejoice International 313fcd4a-8641-417e-bf0b-02359ad815fe 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Berry Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 827365b3-b3a5-4472-9add-f822362c4731 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 8b4160ed-8889-4e3a-947f-a56c3324dbbe 2024-02-09 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM, ZINC OXIDE Medline Industries, LP 101b9933-c2b8-0fdd-e063-6294a90a306a 2024-01-29 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc 2024-01-29 Warnings Exact identifier application number: M016 Cetaphil Baby Healing PETROLATUM Galderma Laboratories, L.P. 5140754e-5db0-470f-adfd-de02b184880b 2024-01-29 Warnings Exact identifier application number: M016 CHAPSTICK CLASSIC MEDICATED CAMPHOR, MENTHOL, PETROLATUM Haleon US Holdings LLC b4259621-ff41-46cc-a658-b57bff3c1525 2024-01-23 Warnings Exact identifier application number: M016 Zinc Oxide 20% ZINC OXIDE Trifecta Pharmaceuticals USA fcef17f1-84e7-a288-e053-6294a90a064b 2024-01-19 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 Marketing end Sample Exclude flag Status 57337-138-01 57337013801 227 g in 1 BOTTLE, PUMP (57337-138-01) 227 g 2021-04-19 0000-00-00 No No Current