First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant

Product NDC: 84126-203
11-digit product format: 841260203
Labeler code: 84126
Product ID: 84126-203_4586178f-147f-fd68-e063-6294a90a1aa2
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal
Dosage form: CREAM
Route: TOPICAL
Labeler: The Procter & Gamble Manufacturing Company
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-11-30
Substance: OATMEAL
Active strength: .5 g/100g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OATMEAL	.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8PI54V663Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1654149	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
446ddb19-4bdb-6827-e063-6394a90a6af8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84126-203-11	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	113 g in 1 JAR	CREAM	113		2
84126-203-17	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	170.1 g in 1 JAR	CREAM	170.1		2
84126-203-22	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	226 g in 1 TUBE	CREAM	226		2
84126-203-28	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	28.3 g in 1 TUBE	CREAM	28.3		2
84126-203-34	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	340.2 g in 1 JAR	CREAM	340.2		2
84126-203-56	First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	56.7 g in 1 TUBE	CREAM	56.7		2
84126-203-56	First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power	56.7 g in 1 TUBE	CREAM	1 g in 56.7	0.5 g in 100g	1
84126-203-56	First Aid Beauty Dry Skin Rescue Kit	56.7 g in 1 TUBE	CREAM	1 g in 56.7	0.5 g in 100g	1

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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Beauty FAB Ultra Repair Body Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1a9d86fc-ef32-baed-e063-6394a90a7d74	2026-03-12	Warnings	Exact identifier application number: M016
Meijer Scar Gel	ALLANTOIN 0.5%	Meijer	4c108c34-72f3-1382-e063-6394a90a7f2c	2026-03-11	Warnings	Exact identifier application number: M016
E2 hand wash	E2 SANITIZING HAND SOAP	Horizon Tool Inc.	a40afa46-a07d-f864-e053-2a95a90aef8a	2026-03-11	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4576cd28-9530-4db4-e063-6394a90a9fd3	2026-03-10	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Lidl US, LLC	e399b33f-5f7c-47eb-8e9b-1721ae4680b5	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	WHITE PETROLATUM	Sion Biotext Medical Ltd.	503c4ab9-1f60-48e2-af47-7ef996466a5b	2026-03-09	Warnings	Exact identifier application number: M016
Trstay	RETINOL SERUM	Shenzhen yuehaotong Technology Co.,Ltd	4c6e20dd-0a71-a96b-e063-6294a90ab833	2026-03-07	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c7f645-cfb3-6db1-e063-6394a90a42ff	2026-03-06	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c89fc6-016b-d359-e063-6394a90a5602	2026-03-06	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a	2026-03-06	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant	DIMETHICONE	The Procter & Gamble Manufacturing Company	276c68d4-e273-4e48-e063-6294a90ab16f	2026-03-04	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4c1d00b3-313b-933f-e063-6294a90ac46f	2026-03-03	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Amazon.com Services LLC	495fffd7-7b64-954a-e063-6394a90a81fd	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Amazon.com Services LLC	aceb0b10-8c90-4a06-8c47-cd1a2b4676a3	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Amazon.com Services LLC	134e07a1-5236-4088-baf9-1ff33126f793	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Old East Main Co.	7f56ab98-dbd8-412a-8c31-bb6302b7f329	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Old East Main Co.	c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Old East Main Co.	ae8583c0-1b52-461d-8506-ec7524f1b4c4	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Old East Main Co.	aa1acc24-56af-4708-bf76-23d4de3d089e	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Old East Main Co.	de8d8071-ecb2-4719-8c7b-7944f27810d6	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1654149	colloidal oatmeal 0.5 % Topical Cream	PSN	446ddb19-4bdb-6827-e063-6394a90a6af8	2
1654149	colloidal oatmeal 5 MG/ML Topical Cream	SCD	446ddb19-4bdb-6827-e063-6394a90a6af8	2
1654149	colloidal oatmeal 0.5 % Topical Cream	SY	446ddb19-4bdb-6827-e063-6394a90a6af8	2
1654149	colloidal oatmeal 0.5 % Topical Cream	PSN	47d06283-21cd-4a69-e063-6294a90adb05	1
1654149	colloidal oatmeal 0.5 % Topical Cream	PSN	4a93d029-d721-0bb5-e063-6294a90a17c4	1
1654149	colloidal oatmeal 5 MG/ML Topical Cream	SCD	47d06283-21cd-4a69-e063-6294a90adb05	1
1654149	colloidal oatmeal 5 MG/ML Topical Cream	SCD	4a93d029-d721-0bb5-e063-6294a90a17c4	1
1654149	colloidal oatmeal 0.5 % Topical Cream	SY	47d06283-21cd-4a69-e063-6294a90adb05	1
1654149	colloidal oatmeal 0.5 % Topical Cream	SY	4a93d029-d721-0bb5-e063-6294a90a17c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84126-203-11	84126020311	113 g in 1 JAR (84126-203-11)	113 g	2025-11-30	No	No	Current
84126-203-17	84126020317	170.1 g in 1 JAR (84126-203-17)	170.1 g	2025-11-30	No	No	Current
84126-203-22	84126020322	226 g in 1 TUBE (84126-203-22)	226 g	2025-11-30	No	No	Current
84126-203-28	84126020328	28.3 g in 1 TUBE (84126-203-28)	28.3 g	2025-11-30	No	No	Current
84126-203-34	84126020334	340.2 g in 1 JAR (84126-203-34)	340.2 g	2025-11-30	No	No	Current
84126-203-56	84126020356	56.7 g in 1 TUBE (84126-203-56)	56.7 g	2025-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Beauty Face and Body Bestsellers Kit	JCS Global Distribution, Inc.	2026-09-10	HUMAN OTC DRUG LABEL	1
First Aid Beauty Face and Body Bestsellers Kit	The Procter & Gamble Manufacturing Company	2026-09-03	HUMAN OTC DRUG LABEL	1
First Aid Beauty Sensitive Skin Bestsellers Kit - JCS Global Distribution, Inc.	JCS Global Distribution, Inc.	2026-07-29	HUMAN OTC DRUG LABEL	1
First Aid Beauty Sensitive Skin Bestsellers Kit	The Procter & Gamble Manufacturing Company	2026-06-03	HUMAN OTC DRUG LABEL	1
First Aid Beauty Sensitive Skin Bestsellers Kit - JCS Global Distribution, Inc.	JCS Global Distribution, Inc.	2026-06-03	HUMAN OTC DRUG LABEL	1
First Aid Beauty Dry Skin Rescue Kit	The Procter & Gamble Manufacturing Company	2026-02-11	HUMAN OTC DRUG LABEL	1
First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power	JCS Global Distribution, Inc.	2026-01-07	HUMAN OTC DRUG LABEL	1
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	The Procter & Gamble Manufacturing Company	2025-12-09	HUMAN OTC DRUG LABEL	2