Home NDC 57337-070 Baby XtraCare Oatmeal
Product NDC 57337-070
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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-070-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57337-070-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-070-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57337-070-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57337-070-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57337-070-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57337-070-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57337-070-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57337-070-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57337-070-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57337-070-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57337-070-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57337-070-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57337-070-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57337-070-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57337-070-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57337-070-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57337-070-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57337-070-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57337-070-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57337-070-01 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57337-070-02 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57337-070-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57337-070-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57337-070-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57337-070-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57337-070-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57337-070-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57337-070-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57337-070-02 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 14 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry LIP BALM SKIN PROTECTANT Suave Brands Company 47a2487d-b2e5-7195-e063-6394a90ae481 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512b5a0-ce1f-c53e-e063-6294a90a56b6 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42770fff-d70a-d9d1-e063-6294a90aa98d 2026-03-30 Warnings Exact identifier application number: M016 Aveeno Skin Relief Healing GLYCERIN Kenvue Brands LLC 345fdde5-700b-7103-e063-6394a90a0e3e 2026-03-27 Warnings Exact identifier application number: M016 Critic Aid Clear PETROLATUM Coloplast Corp 0b6da97e-519b-4579-9895-f4ede5c48b47 2026-03-27 Warnings Exact identifier application number: M016 Baza Protect ZINC OXIDE AND DIMETHICONE Coloplast Corp 256dfcfc-a91c-49b0-9439-452586a0880e 2026-03-27 Warnings Exact identifier application number: M016 Sween 24 DIMETHICONE Coloplast Corp a623c8d7-8db0-410a-9980-02ac02f7b6ea 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect Odor Control DIMETHICONE Coloplast Corp ca5fa4ae-c18d-4457-b520-4a9318ea821f 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect DIMETHICONE Coloplast Corp 82eff041-0c9d-4261-a6b6-5a041a660074 2026-03-27 Warnings Exact identifier application number: M016 Baza Clear PETROLATUM Coloplast Corp 69d9f456-1a35-4146-8366-c0285648a172 2026-03-27 Warnings Exact identifier application number: M016 Vitamin A D LANOLIN, PETROLATUM Topco Associates LLC 5126fdf6-5df5-474b-bc0d-3a82dea61abb 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Advanced Healing PETROLATUM Amazon.com Services LLC cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Dynashield with Dimethicone ZINC OXIDE Dynarex Corporation b5dcf9e8-4689-4a08-ae73-3a859b4cbffe 2026-03-26 Warnings Exact identifier application number: M016 Eczema Relief Cream COLLOIDAL OATMEAL Lavior Pharma Inc bdd2fc9f-2718-1d88-e053-2995a90a8682 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f2dec8-7ffc-fc3e-e063-6294a90a76ff 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f33001-7fec-682e-e063-6394a90a9428 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f3b300-f32f-8881-e063-6394a90a1a2a 2026-03-26 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Dynarex Corporation 81f5092d-0632-bf47-e053-2991aa0ac563 2026-03-25 Warnings Exact identifier application number: M016 MYEVER ESTRIOL CREAM Hubei Redrui Building Materials Co., Ltd. 3ed85485-a441-4c05-e063-6394a90afef5 2026-03-25 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 57337-070-02 57337007002 354 g in 1 BOTTLE (57337-070-02) 354 g 2025-01-01 No No Current