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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0049462b-ff31-440f-9244-b61153625bca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57337-070-01	2025-01-23	0049462b-ff31-440f-9244-b61153625bca
57337-070-02	2025-01-23	0049462b-ff31-440f-9244-b61153625bca
57337-070-01	2020-01-31	0049462b-ff31-440f-9244-b61153625bca
57337-070-02	2020-01-31	0049462b-ff31-440f-9244-b61153625bca

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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
AVENA SATIVA WHOLE	INACTIVE INGREDIENT	5P8D0Z74RG	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BABY XTRACARE OATMEAL (DIMETHICONE) LOTION [REJOICE INTERNATIONAL]	1

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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016
Honest Eczema Balm	COLLOIDAL OATMEAL	The Honest Company, Inc.	35b8bc5c-420e-4d31-9659-f36cabbd897a	2024-05-14	Warnings	Exact identifier application number: M016
Extra Strength Itch Stopping	ITCH STOPPING CREAM	Universal Distribution Centre LLC	b9a42aa3-1903-76f0-e053-2a95a90a51d1	2024-05-13	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier application number: M016
Walgreens Maximum Diaper Rash	ZINC OXIDE	Walgreens Company	5eb2152f-6fa2-4191-878a-207416e69818	2024-05-07	Warnings	Exact identifier application number: M016
Cetaphil Eczema Rapid Relief Cream	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	02a405fa-8ae9-41e9-b86f-ef5fb6e3844a	2024-05-02	Warnings	Exact identifier application number: M016
Chapstick	AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM	Haleon US Holdings LLC	0e34fc74-772e-48fd-a353-58807ef412c1	2024-05-01	Warnings	Exact identifier application number: M016
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier application number: M016
Petrolatum Jelly	PETROLATUM	ASTONEA LABS PRIVATE LIMITED	16dac8e5-aeb8-592d-e063-6394a90ae2b6	2024-04-24	Warnings	Exact identifier application number: M016
Monistat Complete Care Chafing Relief	DIMETHICONE	Insight Pharmaceuticals LLC	07d7c883-1fa3-4786-905c-a1fab649765e	2024-04-19	Warnings	Exact identifier application number: M016
zinc oxide 20%	ZINC OXIDE 20%	Bionpharma Inc	1549500a-0941-0fba-e063-6394a90a564e	2024-04-18	Warnings	Exact identifier application number: M016
ARC Skin Protectant	ALLANTOIN	Anjon Biologics, Inc	f4ff79dd-cb38-4cca-9631-a2758a171873	2024-04-18	Warnings	Exact identifier application number: M016
Zinctral	ZINC OXIDE	PureTek Corporation	de990834-00da-0c7a-e053-2995a90a7c37	2024-04-15	Warnings	Exact identifier application number: M016
Chapstick Moisturizer Variety Pack	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM	Haleon US Holdings LLC	bfb9a2d5-1ad2-45b8-a215-9d1370af5337	2024-04-12	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876980	dimethicone 1.2 % Topical Lotion	PSN	0049462b-ff31-440f-9244-b61153625bca	2
876980	dimethicone 12 MG/ML Topical Lotion	SCD	0049462b-ff31-440f-9244-b61153625bca	2
876980	dimethicone 1.2 % Topical Lotion	SY	0049462b-ff31-440f-9244-b61153625bca	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WATER - Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2025-01-23	HUMAN OTC DRUG LABEL	2