RENEW SKIN REPAIR

Product NDC: 61924-405
11-digit product format: 619240405
Labeler code: 61924
Product ID: 61924-405_9c598909-7909-e69a-e053-2995a90a1402
Type: HUMAN OTC DRUG
Nonproprietary name: OTC SKIN PROTECTANT DRUG PRODUCTS
Dosage form: CREAM
Route: TOPICAL
Labeler: Dermarite Industries LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-03-03
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 0 g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61924-405		I	Inactivated by FDA	2026-10-05
excluded package	package	61924-405	61924-405-04	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-405	61924-405-05	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-405	61924-405-27	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-405	61924-405-32	I	Inactivated by FDA	2026-10-05

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	Snapshot	Source SHA-256
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	61924-405-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-405-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-405-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-405-27	`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	61924-405-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-405-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-405-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-405-27	`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	61924-405-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-405-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-405-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-405-27	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-405-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-405-32	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-405-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-405-27	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-405-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-405-32	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-405-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-405-27	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-405-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-405-32	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-405-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-405-27	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61924-405-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61924-405-32	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61924-405-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61924-405-27	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61924-405-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61924-405-32	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61924-405-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61924-405-27	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61924-405-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61924-405-32	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61924-405-04	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61924-405-27	`bd6a592717d7…`	`303034d00443…`

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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61924-405-04	2026-01-29	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-05	2026-01-29	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-27	2026-01-29	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-32	2026-01-29	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-04	2024-12-06	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-05	2024-12-06	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-27	2024-12-06	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-32	2024-12-06	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-04	2022-01-28	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-05	2022-01-28	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-27	2022-01-28	DRUG LISTING: RENEW SKIN REPAIR CREAM
61924-405-32	2022-01-28	DRUG LISTING: RENEW SKIN REPAIR CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61924-405-04	RENEW SKIN REPAIR	113 g in 1 TUBE	CREAM	113	7
61924-405-05	RENEW SKIN REPAIR	5 g in 1 PACKET	CREAM	5	7
61924-405-27	RENEW SKIN REPAIR	793 g in 1 BAG	CREAM	793	7
61924-405-32	RENEW SKIN REPAIR	907 g in 1 BOTTLE, PUMP	CREAM	907	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Canola Oil	INACTIVE INGREDIENT	331KBJ17RK	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Cholecalciferol	INACTIVE INGREDIENT	1C6V77QF41	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Corn Oil	INACTIVE INGREDIENT	8470G57WFM	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Ethylparaben	INACTIVE INGREDIENT	14255EXE39	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Niacinamide	INACTIVE INGREDIENT	25X51I8RD4	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Pyridoxine Hydrochloride	INACTIVE INGREDIENT	68Y4CF58BV	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61924-405	RENEW SKIN REPAIR (OTC SKIN PROTECTANT DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES LLC]	7	Legacy NDC, 4 package rows	20241208_871cd64d-c3a5-4be9-a8fc-ce8bc28a5f71.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61924-405-04	61924040504	113 g in 1 TUBE (61924-405-04)	113 g	2011-03-03	0000-00-00	No	No	Current
61924-405-05	61924040505	5 g in 1 PACKET (61924-405-05)	5 g	2011-03-03	0000-00-00	No	No	Current
61924-405-27	61924040527	793 g in 1 BAG (61924-405-27)	793 g	2011-03-03	0000-00-00	No	No	Current
61924-405-32	61924040532	907 g in 1 BOTTLE, PUMP (61924-405-32)	907 g	2011-03-03	0000-00-00	No	No	Current