GenRx Daily Defense Skin Repairing

Product NDC: 59088-829
11-digit product format: 590880829
Labeler code: 59088
Product ID: 59088-829_249cafe1-c95b-0070-e063-6394a90a6ba2
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: PureTek Corporation
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-08
Substance: DIMETHICONE
Active strength: 17.5 mg/mL
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	59088-829	59088-829-05	D	Discontinued by firm	2026-10-12
excluded package	package	59088-829	59088-829-08	D	Discontinued by firm	2026-10-12
excluded package	package	59088-829	59088-829-69	D	Discontinued by firm	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 1 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59088-829-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59088-829-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59088-829-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59088-829-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59088-829-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59088-829-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59088-829-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59088-829-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59088-829-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59088-829-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59088-829-69	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59088-829-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59088-829-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59088-829-69	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59088-829-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59088-829-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59088-829-69	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59088-829-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59088-829-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59088-829-69	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59088-829-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59088-829-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59088-829-69	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59088-829-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59088-829-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59088-829-69	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59088-829-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59088-829-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59088-829-69	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59088-829-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59088-829-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59088-829-69	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59088-829-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59088-829-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59088-829-69	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59088-829-08	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: GenRx Daily Defense Skin Repairing
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	17.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148394	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
7d2827fd-b40f-454b-bb60-54d77823b18c	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59088-829-01	GenRx Daily Defense Skin Repairing	4 mL in 1 POUCH	CREAM	4	4
59088-829-05	GenRx Daily Defense Skin Repairing	59 mL in 1 TUBE	CREAM	59	4
59088-829-08	GenRx Daily Defense Skin Repairing	118 mL in 1 TUBE	CREAM	118	4
59088-829-69	GenRx Daily Defense Skin Repairing	144 in 1 CARTON	CREAM	144	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
CARTHAMUS TINCTORIUS SEED OLEOSOMES	INACTIVE INGREDIENT	9S60Q72309	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER	INACTIVE INGREDIENT	RSA9I561OK	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)	INACTIVE INGREDIENT	255PIF62MS	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59088-829	GENRX DAILY DEFENSE SKIN REPAIRING (DIMETHICONE) CREAM [PURETEK CORPORATION]	4	Current NDC, Legacy NDC, 4 package rows	20241018_7d2827fd-b40f-454b-bb60-54d77823b18c.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DawnMist White Petrolatum	WHITE PETROLATUM	Dukal LLC	598e9d46-6450-af60-e063-6394a90a3a6b	2026-08-21	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier application number: M016
Mederma PM	DIMETHICONE	L Perrigo Company	8c728904-28f4-4333-a9ea-20996fd1b007	2026-08-21	Warnings	Exact identifier application number: M016
Earths Care Hemorrhoid Relief	WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	e860d65b-126d-4d77-8003-9d1381849ab5	2026-08-20	Warnings	Exact identifier application number: M016
ClaraVie	PETROLATUM	Gentell LLC	596987e4-4205-b911-e063-6294a90aa570	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier application number: M016
Claravie Skin Repair Cream	DIMETHICONE	Gentell LLC	596ae269-172e-aef5-e063-6394a90a4e2a	2026-08-19	Warnings	Exact identifier application number: M016
Claravie	LANOLIN	Gentell LLC	596c1b73-e34d-c97d-e063-6394a90ada1b	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	LANOLIN	Gentell LLC	596fe32d-be34-0635-e063-6394a90a2fc0	2026-08-19	Warnings	Exact identifier application number: M016
Medpride	ZINC OXIDE	Shield Line LLC	e2689cae-e347-4c0b-825b-6281a0b7c2f1	2026-08-18	Warnings	Exact identifier application number: M016
Eczema Skin Relief Cream	COLLOIDAL OATMEAL	CVS Health	98fac854-f7b0-4c6e-888d-1bdc6b9323b9	2026-08-17	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	ADUSA Distribution, LLC	5940399c-31e3-6d51-e063-6294a90a8e7c	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: M016
Intimate CareGel	HYALURONIC ACID	Guangzhou Yilong Cosmetics.,Ltd	5918d204-52db-e6d0-e063-6394a90ab78c	2026-08-14	Warnings	Exact identifier application number: M016
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M016

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
1148394	dimethicone 1.75 % Topical Cream	PSN	7d2827fd-b40f-454b-bb60-54d77823b18c	4
1148394	dimethicone 17.5 MG/ML Topical Cream	SCD	7d2827fd-b40f-454b-bb60-54d77823b18c	4
1148394	dimethicone 1.75 % Topical Cream	SY	7d2827fd-b40f-454b-bb60-54d77823b18c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
59088-829-01	59088082901	4 mL in 1 POUCH	4 ml	Historical
59088-829-05	59088082905	59 mL in 1 TUBE	59 ml	Historical
59088-829-08	59088082908	118 mL in 1 TUBE	118 ml	Historical
59088-829-69	59088082969	144 in 1 CARTON		Historical