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

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: 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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
insect bite relief 01	MENTHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	006e457d-bfcd-791a-e063-6294a90a8d66	2024-09-23	Warnings	Exact identifier application number: M016
dabur	ZINC OXIDE	Dabur India Limited	22cd1e7a-5448-b3f6-e063-6394a90a880d	2024-09-23	Warnings	Exact identifier application number: M016
DABUR Vitamin A and D	WHITE PETROLATUM	Dabur India Limited	22cd44ef-4b02-604d-e063-6394a90a7a0a	2024-09-23	Warnings	Exact identifier application number: M016
DABUR ZINC OXIDE 3.8%	ZINC OXIDE	Dabur India Limited	2290bbe2-8a88-b94e-e063-6294a90a7e38	2024-09-20	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture	DIMETHICONE	Kenvue Brands LLC	b34c8e71-7fad-484c-b387-3c424f50b743	2024-09-19	Warnings	Exact identifier application number: M016
Evereden Intensive Eczema Balm	COLLOIDAL OATMEAL	Eden Brands Inc.	2243d4ca-5ca4-54d0-e063-6394a90a3940	2024-09-16	Warnings	Exact identifier application number: M016
Whipped Gel	COLLOIDAL OATMEAL	OCEAN OLIVE LLC	222b381c-665e-177d-e063-6394a90a3306	2024-09-15	Warnings	Exact identifier application number: M016
BioBarrier Renewal Cream	ALLANTOIN	bluemercury	1ee15f84-0561-3cd2-e063-6394a90ab68e	2024-09-15	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	21a7c4ce-1360-931c-e063-6294a90aa66d	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	China Ningbo Shangge Cosmetics Technology Corp.	21bdbb13-cc64-b5d7-e063-6294a90ae3fd	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream15oz	PETROLATUM	Rejoice International Corp.	21e4026c-d3da-e4f7-e063-6394a90aabed	2024-09-11	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM OINTMENT	China Ningbo Shangge Cosmetics Technology Corp.	21c0b614-ea19-e98d-e063-6294a90ac44e	2024-09-10	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	65476a2a-8cd4-4477-ac27-9a06f41e4711	2024-09-09	Warnings	Exact identifier application number: M016
Diaper Rash Cream 15oz	ZINC OXIDE	Rejoice International Corp.	213213ab-f935-a62e-e063-6394a90af96b	2024-09-03	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	Rejoice International Corp.	2133876b-eaf0-f988-e063-6394a90aae4d	2024-09-03	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM	Rejoice International Corp.	20cf3bb8-4ab8-2980-e063-6294a90ad631	2024-08-29	Warnings	Exact identifier application number: M016
SUDOCREM SKIN PROTECTANT	ZINC OXIDE	LEDA INNOVATIONS USA, INC.	20d2cf0b-d237-fd78-e063-6394a90a8d03	2024-08-29	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	Rejoice International Corp.	20c9b964-c9af-d63a-e063-6294a90ab979	2024-08-28	Warnings	Exact identifier application number: M016
Babyganics Soothing Itch	OATMEAL	KAS Direct, LLC	5c2806fb-5af4-4532-b31a-be77bb23b277	2024-08-28	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