Home NDC 57337-070-01 Baby XtraCare Oatmeal
Product NDC 57337-070
Requested package NDC 57337-070-01
11-digit product format 573370070
Labeler code 57337
Product ID 57337-070_2c6a4461-23ef-636b-e063-6294a90a1f2a
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone
Dosage form LOTION
Route TOPICAL
Labeler Rejoice International
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-02-16
Substance DIMETHICONE
Active strength 1.2 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Baby XtraCare Oatmeal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1.2 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 876980 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-070-01 Baby XtraCare Oatmeal 227 g in 1 BOTTLE LOTION 227 2 57337-070-02 Baby XtraCare Oatmeal 354 g in 1 BOTTLE LOTION 354 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-070 BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL] 2 Current NDC, Legacy NDC, 2 package rows 20250125_0049462b-ff31-440f-9244-b61153625bca.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 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Baby Soothe and Protect Cream ALLANTOIN Galderma Laboratories, L.P. 38254e03-3716-4e45-86b7-06430ebadc86 2023-11-22 Warnings Exact identifier application number: M016 Cetaphil Baby Eczema Soothing COLLOIDAL OATMEAL Galderma Laboratories, L.P. d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b 2023-11-22 Warnings Exact identifier application number: M016 EczemaHoneyBodyLotion COLLOIDAL OATMEAL Allure Labs 0a710be0-562e-8368-e063-6294a90a3b1b 2023-11-18 Warnings Exact identifier application number: M016 Zinc Oxide SKIN PROTECTANT BluePoint Laboratories d9b752e6-655a-19a6-e053-2995a90a9a37 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL ORIGINAL PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 47b8c720-ad1e-4ac7-ba73-872e409b38bf 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL LAVENDER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 1ac9ee69-339d-4426-b3bf-13e5386f1a9b 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL COCOA BUTTER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC cf888bf3-6950-43aa-b4be-5a32961b4d96 2023-11-15 Warnings Exact identifier application number: M016 UNIVERSAL BABY FRESH SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC b6e0ddb8-3761-482a-83d0-15d612d142eb 2023-11-15 Warnings Exact identifier application number: M016 DERMA SANTE Anti Eczema Cream OATMEAL Hope Science Inc. 1492a6ad-016c-4307-8286-5c564de9e160 2023-11-11 Warnings Exact identifier application number: M016 M3 NATURALS Eczema Cream OATMEAL M3 Naturals LLC 45e2cdde-58fb-4eea-a54d-f53f9ad0d854 2023-11-11 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 53900588-5c9e-4164-816d-017bdbb0f31b 2023-11-11 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Max Strength ZINC OXIDE Geodis Logistics LLC 1b4fd6cb-f2dc-40a2-b958-e99caec91793 2023-11-10 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Original ZINC OXIDE Geodis Logistics LLC 97587458-4ca0-4de3-9bb9-148346d859c0 2023-11-10 Warnings Exact identifier application number: M016 EltaMD Laser Balm PETROLATUM SKIN PROTECTANT CP Skin Health Group, Inc 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb 2023-11-09 Warnings Exact identifier application number: M016 DiaperDerm Diaper Rash ZINC OXIDE Diaperderm Inc 4e1fce3e-c2b7-42da-9953-1dbb13e2467c 2023-11-06 Warnings Exact identifier application number: M016 Doctors Diaper Rash Cream ZINC OXIDE DOCTOR'S DIAPER RASH CREAM, INC 0988ccb1-7881-4d97-bcbf-d0cf4316e4be 2023-11-06 Warnings Exact identifier application number: M016 DERMOIA Manuka Honey Eczema Cream OATMEAL TREASUREWISE LLC a48e52a3-b681-4489-a1fd-6b09d8bc9c55 2023-11-06 Warnings Exact identifier application number: M016 GL HEALTH Barrier Skin Protectant ZINC OXIDE GL HEALTH, INC. 76cfa330-fea9-48d4-b187-469154765d39 2023-11-06 Warnings Exact identifier application number: M016 Skin-lube PETROLATUM, DIMETHICONE The Hygenic Company, LLC. d1005dec-04f6-3f88-e053-2a95a90ad9cb 2023-11-05 Warnings Exact identifier application number: M016 Dr. Sheffield Anti Itch Cream ANTI ITCH CREAM Sheffield Pharmaceuticals LLC 77f0593e-f694-4c02-9fd9-ad56ff2a920c 2023-10-30 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 57337-070-01 57337007001 227 g in 1 BOTTLE (57337-070-01) 227 g 2025-01-01 No No Current