Hand Essentials Skin Repair

Product NDC: 65626-161
11-digit product format: 656260161
Labeler code: 65626
Product ID: 65626-161_d102e331-fd3f-46ca-9382-2f103afbc853
Type: HUMAN OTC DRUG
Nonproprietary name: dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: HU-FRIEDY MFG. CO., INC.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-10-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 2 mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65626-161		I	Inactivated by FDA	2026-10-12
excluded package	package	65626-161	65626-161-04	I	Inactivated by FDA	2026-10-12
excluded package	package	65626-161	65626-161-13	I	Inactivated by FDA	2026-10-12
excluded package	package	65626-161	65626-161-23	I	Inactivated by FDA	2026-10-12
excluded package	package	65626-161	65626-161-96	I	Inactivated by FDA	2026-10-12

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 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65626-161-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65626-161-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65626-161-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65626-161-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65626-161-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65626-161-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65626-161-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65626-161-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65626-161-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65626-161-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65626-161-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65626-161-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65626-161-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65626-161-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65626-161-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65626-161-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65626-161-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65626-161-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65626-161-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65626-161-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65626-161-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65626-161-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65626-161-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65626-161-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65626-161-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65626-161-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65626-161-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65626-161-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65626-161-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65626-161-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65626-161-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65626-161-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65626-161-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65626-161-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65626-161-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65626-161-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65626-161-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65626-161-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65626-161-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65626-161-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65626-161-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65626-161-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65626-161-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65626-161-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65626-161-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65626-161-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65626-161-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65626-161-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
65626-161-04	Drug Facts
65626-161-13	Drug Facts
65626-161-23	Drug Facts
65626-161-96	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65626-161-04	Hand Essentials Skin Repair	118 mL in 1 TUBE	CREAM	118	2
65626-161-13	Hand Essentials Skin Repair	59 mL in 1 TUBE	CREAM	59	2
65626-161-23	Hand Essentials Skin Repair	946 mL in 1 BOTTLE, PUMP	CREAM	946	2
65626-161-96	Hand Essentials Skin Repair	4 mL in 1 PACKET	CREAM	4	2
65626-161-96	Hand Essentials Skin Repair	144 in 1 CARTON	CREAM	144	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
ACETYLCYSTEINE	INACTIVE INGREDIENT	WYQ7N0BPYC	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
MANDARIN OIL	INACTIVE INGREDIENT	NJO720F72R	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
TAURINE	INACTIVE INGREDIENT	1EQV5MLY3D	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
VANILLIN	INACTIVE INGREDIENT	CHI530446X	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65626-161	HAND ESSENTIALS SKIN REPAIR (DIMETHICONE) CREAM [HU-FRIEDY MFG. CO., INC.]	2	Legacy NDC, 5 package rows	20120329_e3ed1718-8e24-44e6-a790-18723c426ac2.zip

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
309917	dimethicone 1.5 % Topical Cream	PSN	e3ed1718-8e24-44e6-a790-18723c426ac2	2
309917	dimethicone 15 MG/ML Topical Cream	SCD	e3ed1718-8e24-44e6-a790-18723c426ac2	2
309917	dimethicone 1.5 % Topical Cream	SY	e3ed1718-8e24-44e6-a790-18723c426ac2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65626-161-04	65626016104	118 mL in 1 TUBE	118 ml	Historical
65626-161-13	65626016113	59 mL in 1 TUBE	59 ml	Historical
65626-161-23	65626016123	946 mL in 1 BOTTLE, PUMP	946 ml	Historical
65626-161-96	65626016196	4 mL in 1 PACKET	4 ml	Historical