Dimethicone

Product NDC: 68599-0213
11-digit product format: 685990213
Labeler code: 68599
Product ID: 68599-0213_24c0a59c-1fad-f54e-e063-6394a90a5057
Type: HUMAN OTC DRUG
Nonproprietary name: Body Shield
Dosage form: CREAM
Route: TOPICAL
Labeler: McKesson
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-12
Substance: DIMETHICONE
Active strength: 50 ug/mg
Pharmacologic classes: Skin Barrier Activity [PE]
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: Dimethicone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	50 ug/mg

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8febb45d-a200-702c-e053-2995a90a3e62	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2f8c312-f164-6104-0de4-ec45484840e3	Product name	2	20260304
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
0c2e0212-b823-4ce8-611e-853ac2cac1b2	Product name	4	20230327
4d1338f1-f50a-5bb5-4946-11534fdee48f	Product name	2	20210527
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
c148aeb5-688c-9b49-a40f-30a41e3595e4	Product name	2	20180419
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
3db2f5c1-f78c-f062-515c-4827e36c2518	Product name	1	20140508
6f16fc1e-e77d-460f-8810-a12ca121425c	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
f74f326b-f453-01a0-e7e7-ce5ea9475503	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68599-0213-4	Dimethicone	118 mg in 1 BOTTLE	CREAM	118		4
68599-0213-4	NuDermRxPAK 60	118 mg in 1 BOTTLE	CREAM	118 mg	50 ug in 1mg	2
68599-0213-4	NuDermRxPAK 120	118 mg in 1 BOTTLE	CREAM	118 mg	50 ug in 1mg	2
68599-0213-4	NuSurgePak Surgical Prep/CarePak	118 mg in 1 BOTTLE	CREAM	118 mg	50 ug in 1mg	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0213	DIMETHICONE (BODY SHIELD) CREAM [MCKESSON]	4	Current NDC, Legacy NDC, 1 package rows	20241020_8febb45d-a200-702c-e053-2995a90a3e62.zip
68599-0213	NUDERMRXPAK 120 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC	20210506_a838204b-9564-9aa6-e053-2a95a90af02f.zip
68599-0213	NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC	20210511_a837f13e-fafc-0535-e053-2995a90a5070.zip
68599-0213	NUSURGEPAK SURGICAL PREP/CAREPAK (CHLORHEXIDINE GLUCONATE, MUPIROCIN, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS INC]	2	Current NDC, Legacy NDC	20200623_a83a55e8-58df-ac57-e053-2a95a90a9425.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 43 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b20bd5-3b4f-8cc7-e063-6394a90a9106	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b2744d-fb59-f383-e063-6294a90abd2a	2025-03-19	Warnings	Exact identifier application number: M016
Dr. Butler Hemorrhoid and Perineal	MINERAL OIL 59.8%,PETROLATUM 36%	Beyond Health P.A.	d17b6f16-6893-ce0a-e053-2a95a90aa23a	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream	DIMETHICONE, WHITE PETROLATUM	Chattem, Inc.	b951d1cb-b81e-4d7f-9a67-8405daa89667	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Hand Cream	COLLOIDAL OATMEAL	Chattem, Inc.	27457bc5-3edc-4c8b-b8a2-eaf09b511cf8	2025-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	30a977c3-6862-670e-e063-6294a90aeb2f	2025-03-18	Warnings	Exact identifier application number: M016
YVTYVT Copper Peptides Face Serum	COPPER TRIPEPTIDE-1	Beijing JUNGE Technology Co., Ltd.	306f2d48-43b8-359a-e063-6394a90a06dc	2025-03-16	Boxed warning, Warnings	Exact identifier application number: M016
Dr Talbots Cooling Perineal Pad	WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE	Talbot's Pharmaceuticals family Products, LLC.	242277e2-ff26-ad4e-e063-6394a90ab317	2025-03-14	Warnings	Exact identifier application number: M016
RID Poison Ivy Rash Relief	CALAMINE AND ZINC OXIDE	Oystershell Consumer Health Inc.	36c3af9a-2646-4427-e063-6394a90a2c5e	2025-03-13	Warnings	Exact identifier application number: M016
Aavini Double Layer Brightening Spot Correcting Essence Oil	AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL	Qingyuan Moksha Biotechnology Co., Ltd.	2ff89a13-3969-2df1-e063-6394a90ac0d3	2025-03-10	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3008bbeb-abba-5cdb-e063-6294a90ae483	2025-03-10	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2fc4745c-fac9-7861-e063-6294a90a3f14	2025-03-07	Warnings	Exact identifier application number: M016
AD Skin Protectant	AD SKIN PROTECTANT	WellSpring Pharmaceutical Corporation	d26f1312-2e1b-4106-bc48-a336d4e034ad	2025-03-07	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Nighttime Balm	OATMEAL	Kenvue Brands LLC	04d90e45-c2ee-4122-b919-a0eb6d11b59a	2025-03-04	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% SIGNATURE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f80abc0-49d8-968d-e063-6294a90a555b	2025-03-04	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	f19b3056-063c-63ec-e053-2995a90a4614	2025-03-04	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2770424d-7414-66d4-e063-6394a90ad4b1	2025-03-04	Warnings	Exact identifier application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	026bb3a1-3e01-1530-e063-6294a90ab1b1	2025-03-04	Warnings	Exact identifier application number: M016
5% Dr.care Numb cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f905d76-ef9c-c844-e063-6394a90a4dc9	2025-03-04	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	1590101a-c968-fca5-e063-6394a90a7ccc	2025-02-28	Warnings	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
313921	calcipotriene 0.005 % Topical Cream	PSN	a837f13e-fafc-0535-e053-2995a90a5070	2
313921	calcipotriene 0.005 % Topical Cream	PSN	a838204b-9564-9aa6-e053-2a95a90af02f	2
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	PSN	a83a55e8-58df-ac57-e053-2a95a90a9425	2
106346	mupirocin 2 % Topical Ointment	PSN	a83a55e8-58df-ac57-e053-2a95a90a9425	2
313921	calcipotriene 0.05 MG/ML Topical Cream	SCD	a837f13e-fafc-0535-e053-2995a90a5070	2
313921	calcipotriene 0.05 MG/ML Topical Cream	SCD	a838204b-9564-9aa6-e053-2a95a90af02f	2
211365	chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap	SCD	a83a55e8-58df-ac57-e053-2a95a90a9425	2
106346	mupirocin 0.02 MG/MG Topical Ointment	SCD	a83a55e8-58df-ac57-e053-2a95a90a9425	2
313921	calcipotriene (as calcipotriene monohydrate) 0.005 % Topical Cream	SY	a837f13e-fafc-0535-e053-2995a90a5070	2
313921	calcipotriene (as calcipotriene monohydrate) 0.005 % Topical Cream	SY	a838204b-9564-9aa6-e053-2a95a90af02f	2
313921	calcipotriene 0.005 % Topical Cream	SY	a837f13e-fafc-0535-e053-2995a90a5070	2
313921	calcipotriene 0.005 % Topical Cream	SY	a838204b-9564-9aa6-e053-2a95a90af02f	2
211365	chlorhexidine gluconate 4 % Medicated Liquid Soap	SY	a83a55e8-58df-ac57-e053-2a95a90a9425	2
211365	chlorhexidine gluconate 4 % Medicated Surgical Scrub	SY	a83a55e8-58df-ac57-e053-2a95a90a9425	2
106346	mupirocin 2 % Topical Ointment	SY	a83a55e8-58df-ac57-e053-2a95a90a9425	2
106346	mupirocin 20 MG per GM Topical Ointment	SY	a83a55e8-58df-ac57-e053-2a95a90a9425	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68599-0213-4	68599021304	118 mg in 1 BOTTLE (68599-0213-4)	118 mg	2019-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Body Shield Dimethicone	McKesson \| Central Solutions	2024-10-18	HUMAN OTC DRUG LABEL	4
NuTriaRX CreamPak - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
NuDermRxPAK 120 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
NuDermRxPAK 60 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-03	HUMAN PRESCRIPTION DRUG LABEL	2
NuSurgePak Surgical Prep/CarePak - Nucare Pharmaceuticals Inc	Nucare Pharmaceuticals Inc	2020-06-22	HUMAN PRESCRIPTION DRUG LABEL	2