Dimethicone

Product NDC: 68599-0218
11-digit product format: 685990218
Labeler code: 68599
Product ID: 68599-0218_1b2a2a80-2961-a52f-e063-6294a90a8c4d
Type: HUMAN OTC DRUG
Nonproprietary name: Skin Protectant
Dosage form: CREAM
Route: TOPICAL
Labeler: McKesson
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-11-04
Substance: DIMETHICONE
Active strength: 17.5 ug/mg
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68599-0218	68599-0218-1	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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: Dimethicone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	17.5 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 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
96886b33-44d4-5a2a-e053-2a95a90a505e	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68599-0218-1	Dimethicone	1000 mg in 1 BAG	CREAM	1000	4
68599-0218-4	Dimethicone	118 mg in 1 TUBE	CREAM	118	4
68599-0218-8	Dimethicone	946 mg in 1 BOTTLE	CREAM	946	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68599-0218-4	ML - Milliliter	68599-0218	b9394372-c923-4552-b1b6-a55b498a5440	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0218	DIMETHICONE (SKIN PROTECTANT) CREAM [MCKESSON]	4	Current NDC, Legacy NDC, 3 package rows	20240619_96886b33-44d4-5a2a-e053-2a95a90a505e.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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	Exact identifier application number: M016
DERMFREE Vein Target Microneedle Patch	ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57449e29-ec46-9c30-e063-6394a90a7b4a	2026-07-23	Warnings	Exact identifier application number: M016
Baby Vitamin A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a125ea-6f9f-310c-e063-6394a90acef2	2026-07-22	Warnings	Exact identifier application number: M016
First Aid A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a319d0-d39a-5ff0-e063-6394a90a671d	2026-07-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier application number: M016
Dermasporin	LANOLIN	Marie's Original Formulas LLC	562f40aa-eeec-2b7c-e063-6294a90ad68d	2026-07-22	Warnings	Exact identifier application number: M016
CAREALL Vitamin A and D	PETROLATUM	New World Imports, Inc	ef89a68a-74c1-4c42-8078-b7a208ace0de	2026-07-22	Warnings	Exact identifier application number: M016
Dermact	LANOLIN	Marie's Original Formulas LLC	57121dbe-e886-a562-e063-6294a90a367f	2026-07-22	Warnings	Exact identifier application number: M016
Universal WITCH HAZEL	WITCH HAZEL	Universal Distribution Center LLC	7e0b56ef-fa41-4862-b387-5b58d81d67d4	2026-07-22	Warnings	Exact identifier application number: M016
Aveeno Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	0c410b8e-025f-477c-afac-6e2e9ac88f7d	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE SCAR SHEETS	SILICONE GEL 1% SCAR SHEETS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4ce316-4b92-7e81-e063-6294a90af6db	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE VARICOSE VEINS	DIMETHICONE 3% VARICOSE VEINS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a2d1d-9e84-18eb-e063-6394a90a97ee	2026-07-21	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	571083ce-cd35-a638-e063-6394a90ae4c7	2026-07-20	Warnings	Exact identifier application number: M016
Mederma Stretch Marks Therapy	DIMETHICONE	PMI Branded Pharmaceuticals, Inc.	0f2918e3-9615-40e3-ab7e-6bfbe022e03c	2026-07-16	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Better Living Brands, LLC	c7ef0ef3-6861-4b94-af4b-371fee8c1f3d	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: M016
Dove	MEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BAR	Conopco d/b/a Unilever	56bd6fcb-c762-4e5a-e063-6394a90a3438	2026-07-16	Warnings	Exact identifier application number: M016
Mederma Advanced Scar	ALLANTOIN	PMI Branded Pharmaceuticals, Inc.	25bc1eae-3502-4c63-bd8a-43be2dfb0d6d	2026-07-16	Warnings	Exact identifier application number: M016
Mederma Advanced Scar	ALLANTOIN	L. Perrigo Company	9c3d9e08-9428-4b28-82a2-0cb24c3c92a3	2026-07-16	Warnings	Exact identifier application number: M016
aftershave	CERAMIDE NP	Shengnan (Guangzhou) Cosmetics Co., LTD	56a17ac9-803b-932c-e063-6394a90aae90	2026-07-15	Warnings	Exact identifier application number: M016
Clear Root Labs Wound Care	CRL WOUND CARE OINTMENT	Aidance Scientific Inc. DBA Aidance Skincare & Topicals	56a6dbc7-5001-c095-e063-6294a90a1aa0	2026-07-15	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
1148394	dimethicone 1.75 % Topical Cream	PSN	96886b33-44d4-5a2a-e053-2a95a90a505e	4
1148394	dimethicone 17.5 MG/ML Topical Cream	SCD	96886b33-44d4-5a2a-e053-2a95a90a505e	4
1148394	dimethicone 1.75 % Topical Cream	SY	96886b33-44d4-5a2a-e053-2a95a90a505e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68599-0218-1	68599021801	1000 mg in 1 BAG (68599-0218-1)	1000 mg	2019-11-04	0000-00-00	No	No	Current
68599-0218-4	68599021804	118 mg in 1 TUBE (68599-0218-4)	118 mg	2019-11-04	0000-00-00	No	No	Current
68599-0218-8	68599021808	946 mg in 1 BOTTLE (68599-0218-8)	946 mg	2019-11-04	0000-00-00	No	No	Current