THERA Dimethicone Body Shield

Product NDC: 68599-0203
11-digit product format: 685990203
Labeler code: 68599
Product ID: 68599-0203_03cadffe-c466-417e-9bae-eb26381da4e0
Type: HUMAN OTC DRUG
Nonproprietary name: Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: McKesson Medical-Surgical Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-09-01
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 50 uL/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68599-0203		D	Discontinued by firm		2026-08-17
excluded package	package	68599-0203	68599-0203-4	D	Discontinued by firm		2026-08-17

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68599-0203-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68599-0203-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68599-0203-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68599-0203-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68599-0203-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68599-0203-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68599-0203-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68599-0203-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68599-0203-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68599-0203-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68599-0203-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68599-0203-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68599-0203-4	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68599-0203-4	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d4d7da1a-7fd4-628e-cdae-89e749b1c534	Product name	7	20260127
75f7e47b-8736-a182-fc44-22aca8d79689	Product name	2	20251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2	Product name	6	20250516
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
e42f429b-c4e5-0402-e1c5-730154df4060	Product name	4	20240205
38d4de13-64b3-4057-b91c-4b5126962341	Product name	1	20220516
4d1338f1-f50a-5bb5-4946-11534fdee48f	Product name	2	20210527
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
089e0644-1ea8-8654-4113-39f960dd57d5	Product name	3	20210115
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
1629e00f-54fb-4a43-8306-b58442b23902	Product name	9	20200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0b	Product name	7	20190612
c148aeb5-688c-9b49-a40f-30a41e3595e4	Product name	2	20180419
9f64e0dc-109c-9660-8e0e-91ec987b3817	Product name	6	20171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002f	Product name	1	20171204
8de20f81-8411-4cf1-a8b2-03404ee56d01	Product name	3	20171109
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
a5f1a68c-0352-4f34-46a3-9b4eed239ed8	Product name	2	20160819
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
355b2224-0895-7135-83f5-d099a6a82a0a	Product name	1	20140508
55be6b50-8cc0-f0f1-74a1-3416a91193aa	Product name	1	20140508
6f16fc1e-e77d-460f-8810-a12ca121425c	Product name	1	20140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cf	Product name	1	20140508
89b93c13-4be8-69f3-b33b-63e64feffb9b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68599-0203-4	2020-07-10	C162847	48780-1	97431aae-1640-960c-e053-dbdaa90a7534	Drug Facts
68599-0203-4	2019-11-13	C162847	48780-1	97431aae-1640-960c-e053-dbdaa90a7534	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68599-0203-4	NuTriaRX CreamPak	118 mL in 1 TUBE	CREAM	118 mL	50 mg in 1mL	2
68599-0203-4	NuDermRxPAK 120	118 mL in 1 TUBE	CREAM	118 mL	50 mg in 1mL	1
68599-0203-4	NuDermRxPAK 60	118 mL in 1 TUBE	CREAM	118 mL	50 mg in 1mL	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERA DIMETHICONE BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0203	NUTRIARX CREAMPAK (RIAMCINOLONE ACETONIDE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS, INC.]	2	Legacy NDC	20181107_736c0400-88de-c02e-e053-2a91aa0a2264.zip
68599-0203	NUDERMRXPAK 120 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20190529_89f6689b-ef95-613b-e053-2a95a90ac161.zip
68599-0203	NUDERMRXPAK 60 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC	20190525_89a98b7c-d36b-6016-e053-2a95a90aa31b.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
259090	dimethicone 5 % Topical Cream	PSN	736c0400-88de-c02e-e053-2a91aa0a2264	2
1014314	triamcinolone acetonide 0.1 % Topical Cream	PSN	736c0400-88de-c02e-e053-2a91aa0a2264	2
259090	dimethicone 50 MG/ML Topical Cream	SCD	736c0400-88de-c02e-e053-2a91aa0a2264	2
1014314	triamcinolone acetonide 1 MG/ML Topical Cream	SCD	736c0400-88de-c02e-e053-2a91aa0a2264	2
259090	dimethicone 5 % Topical Cream	SY	736c0400-88de-c02e-e053-2a91aa0a2264	2
1014314	triamcinolone acetonide 0.1 % Topical Cream	SY	736c0400-88de-c02e-e053-2a91aa0a2264	2
1014314	triamcinolone acetonide 1 MG per GM Topical Cream	SY	736c0400-88de-c02e-e053-2a91aa0a2264	2
313921	calcipotriene 0.005 % Topical Cream	PSN	89f6689b-ef95-613b-e053-2a95a90ac161	1
313921	calcipotriene 0.005 % Topical Cream	PSN	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
259090	dimethicone 5 % Topical Cream	PSN	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
259090	dimethicone 5 % Topical Cream	PSN	89f6689b-ef95-613b-e053-2a95a90ac161	1
313921	calcipotriene 0.05 MG/ML Topical Cream	SCD	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
313921	calcipotriene 0.05 MG/ML Topical Cream	SCD	89f6689b-ef95-613b-e053-2a95a90ac161	1
259090	dimethicone 50 MG/ML Topical Cream	SCD	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
259090	dimethicone 50 MG/ML Topical Cream	SCD	89f6689b-ef95-613b-e053-2a95a90ac161	1
313921	calcipotriene (as calcipotriene monohydrate) 0.005 % Topical Cream	SY	89f6689b-ef95-613b-e053-2a95a90ac161	1
313921	calcipotriene (as calcipotriene monohydrate) 0.005 % Topical Cream	SY	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
313921	calcipotriene 0.005 % Topical Cream	SY	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
313921	calcipotriene 0.005 % Topical Cream	SY	89f6689b-ef95-613b-e053-2a95a90ac161	1
259090	dimethicone 5 % Topical Cream	SY	89a98b7c-d36b-6016-e053-2a95a90aa31b	1
259090	dimethicone 5 % Topical Cream	SY	89f6689b-ef95-613b-e053-2a95a90ac161	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68599-0203-4	68599020304	118 mL in 1 TUBE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NuSurgePak Surgical Prep/CarePak	Nucare Pharmaceuticals Inc \| Xttrium Laboratories, Inc. \| Glenmark Pharmaceuticals Ltd \| PureTek Corporation	2022-11-04	HUMAN PRESCRIPTION DRUG LABEL	6
NuDermRxPAK 120 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2019-05-28	HUMAN PRESCRIPTION DRUG LABEL	1
NuDermRxPAK 60 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2019-05-24	HUMAN PRESCRIPTION DRUG LABEL	1
NuTriaRX CreamPak - Nucare Pharmaceuticals, Inc. \| NuCare Pharmaceuticals,Inc.	Nucare Pharmaceuticals, Inc. \| NuCare Pharmaceuticals,Inc.	2018-11-06	HUMAN PRESCRIPTION DRUG LABEL	2
Drug Facts	McKesson Medical-Surgical Inc. \| PureTek Corporation	2011-09-01	HUMAN OTC DRUG LABEL	1