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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	4a43b1a2-2156-e490-e063-6294a90a6f84	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE 8%, ZINC OXIDE 8%	Farmacias De Similares TX LLC	4ecd0add-11c9-cf3b-e063-6394a90adff6	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	CVS Pharmacy, Inc.	4dc08832-e610-4e62-a6af-cadaa339e39e	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL SPRAY	CVS Pharmacy	53db78a8-eb2d-431b-84c1-73e99bb9d3d1	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Amazon.com Services LLC	616ef87d-1518-46aa-8e12-9a1b678d4980	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Stabilizing Repair Serum	OATMEAL	Dermalogica, LLC.	86b7b230-5424-46d3-8058-656f5172fc70	2026-04-02	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	STRATEGIC SOURCING SERVICES	4e6a7bdf-4ef1-65e2-e063-6394a90ae124	2026-04-01	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	4e4e1797-26e6-a67b-e063-6294a90af438	2026-03-31	Warnings	Exact identifier application number: M016
Target Advanced Scar Gel	ADVANCED SCAR GEL	Target Corporation	86c215fe-aad4-45d1-bdb7-cde00a115c5c	2026-03-31	Warnings	Exact identifier application number: M016
Zinc oxide, Dimethicone	ZINC OXIDE, DIMETHICONE	Walmart Inc.	4cbf9492-33cd-e6d4-e063-6294a90ab001	2026-03-31	Warnings, Adverse reactions	Exact identifier application number: M016
Critic-Aid Clear	PETROLATUM	Coloplast Corp	a92c18f7-52b2-43e4-bae3-2bab9de22671	2026-03-31	Warnings	Exact identifier application number: M016
3M Cavilon Durable Barrier	DIMETHICONE	Solventum US LLC	f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83	2026-03-31	Warnings	Exact identifier application number: M016
XIMONTH Foot Sanitizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	4e38d24d-3745-c121-e063-6394a90abbb5	2026-03-30	Warnings	Exact identifier application number: M016
Dynashield	ZINC OXIDE	Dynarex Corporation	59fd865c-b81d-43ad-8fa0-c37ca0557769	2026-03-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	COLLOIDAL OATMEAL	Port Jervis Laboratories, Inc	4e43b65c-d5bb-f228-e063-6294a90ad08d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4275956d-275a-4e31-e063-6394a90a78d3	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42762471-e5cd-505e-e063-6294a90afb7d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Variety Cherry-Strawberry-Spearmint	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	450e46d2-de86-e5fa-e063-6294a90ac6ff	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4512220a-9fc2-8816-e063-6394a90a9d15	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original Military	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	45136b7e-136b-0283-e063-6394a90a599a	2026-03-30	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