SKINFIX HAND REPAIR

Product NDC: 61328-106
11-digit product format: 613280106
Labeler code: 61328
Product ID: 61328-106_48338cc0-20ec-8999-e063-6394a90aba83
Type: HUMAN OTC DRUG
Nonproprietary name: OATMEAL
Dosage form: CREAM
Route: TOPICAL
Labeler: Skinfix, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-07-02
Substance: OATMEAL
Active strength: 1 g/100mL
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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: SKINFIX HAND REPAIR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OATMEAL	1 g/100mL

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
240651	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
1b65fc81-1b9e-4260-829a-332cf6891d02	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61328-106-11	SKINFIX HAND REPAIR	30 mL in 1 TUBE	CREAM	30		11
61328-106-13	SKINFIX HAND REPAIR	90 mL in 1 TUBE	CREAM	90		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
OATMEAL	ACTIVE MOIETY	8PI54V663Y	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
CALENDULA OFFICINALIS WHOLE	INACTIVE INGREDIENT	PFR03EBU0H	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
CAPRYLYL CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	22MCG4RSMR	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
MATRICARIA CHAMOMILLA WHOLE	INACTIVE INGREDIENT	2Z4LRR776S	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
OAT KERNEL OIL	INACTIVE INGREDIENT	3UVP41R77R	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ORYZA SATIVA WHOLE	INACTIVE INGREDIENT	84IVV0906Z	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
POLYGLYCERYL-2 DIISOSTEARATE	INACTIVE INGREDIENT	DG195GP57P	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
ROSMARINUS OFFICINALIS WHOLE	INACTIVE INGREDIENT	EA3289138M	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
TRISODIUM ETHYLENEDIAMINE DISUCCINATE	INACTIVE INGREDIENT	YA22H34H9Q	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61328-106	SKINFIX HAND REPAIR (OATMEAL) CREAM [SKINFIX, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20241228_1b65fc81-1b9e-4260-829a-332cf6891d02.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 1 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Jelly, Lil Drug Store	PETROLATUM JELLY	Lil' Drug Store Products, Inc.	5862af40-97e2-d792-e063-6394a90a0f1a	2026-08-06	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Walgreens	1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f5	2026-08-04	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-03	Warnings	Exact identifier application number: M016
Nail Treatment Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE	ZINC OXIDE	TWIN MED, LLC	e68ae97e-668e-31c2-e053-2995a90ab4d3	2026-08-03	Warnings	Exact identifier application number: M016
PROCURE VITAMIN A AND D Skin Protectant	PETROLATUM	TWIN MED, LLC	bbbca68e-1b65-49b1-a5fa-ed4da55d05e3	2026-08-03	Warnings	Exact identifier application number: M016
procure	PETROLATUM	TWIN MED, LLC	32520d8f-91ee-47a1-9129-bf0746791f4b	2026-08-03	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 44.28%	Twin Med LLC	3ab7bfb2-bbcf-0822-e063-6294a90af084	2026-08-03	Warnings	Exact identifier application number: M016
456 Acne Relief Cream	NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT	Guangzhou Senmai Biotechnology Co.,Ltd.	5830fd36-0613-1980-e063-6294a90adfb7	2026-08-03	Warnings	Exact identifier application number: M016
Crogooe Skin Relief Cream	COLLOIDAL OATMEAL	Guangdong Outeli Biotechnology Co., Ltd.	57f9b3e8-25d3-2b20-e063-6394a90aaea5	2026-08-01	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	57c3556a-aad3-3e65-e063-6394a90ab689	2026-07-29	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
ATTITUDE Baby Leaves Diaper cream - Unscented	ZINC OXIDE	9055-7588 Quebec Inc. (Attitude)	579aa481-f8ec-b263-e063-6394a90a7754	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	Warnings	Exact identifier application number: M016
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	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
240651	colloidal oatmeal 1 % Topical Cream	PSN	1b65fc81-1b9e-4260-829a-332cf6891d02	11
240651	colloidal oatmeal 10 MG/ML Topical Cream	SCD	1b65fc81-1b9e-4260-829a-332cf6891d02	11
240651	Avena sativa 1 % Topical Cream	SY	1b65fc81-1b9e-4260-829a-332cf6891d02	11
240651	colloidal oatmeal 1 % Topical Cream	SY	1b65fc81-1b9e-4260-829a-332cf6891d02	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61328-106-10	61328010610	10 mL in 1 TUBE (61328-106-10)	10 ml	2017-03-15	0000-00-00	No	No	Current
61328-106-11	61328010611	30 mL in 1 TUBE (61328-106-11)	30 ml	2016-09-23	0000-00-00	No	No	Current
61328-106-12	61328010612	60 mL in 1 TUBE (61328-106-12)	60 ml	2016-09-23	0000-00-00	No	No	Current
61328-106-13	61328010613	90 mL in 1 TUBE (61328-106-13)	90 ml	2014-07-02	0000-00-00	No	No	Current
61328-106-15	61328010615	150 mL in 1 TUBE (61328-106-15)	150 ml	2018-10-01	0000-00-00	No	No	Current
61328-106-16	61328010616	148 mL in 1 PACKAGE (61328-106-16)	148 ml	2018-12-26	0000-00-00	No	No	Current
61328-106-97	61328010697	7 mL in 1 POUCH (61328-106-97)	7 ml	2016-09-23	0000-00-00	No	No	Current