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
IngredientStrength
DIMETHICONE50 ug/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8febb45d-a200-702c-e053-2995a90a3e62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0213-4Dimethicone118 mg in 1 BOTTLECREAM1184
68599-0213-4NuDermRxPAK 60118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2
68599-0213-4NuDermRxPAK 120118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2
68599-0213-4NuSurgePak Surgical Prep/CarePak118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0213DIMETHICONE (BODY SHIELD) CREAM [MCKESSON]4Current NDC, Legacy NDC, 1 package rows20241020_8febb45d-a200-702c-e053-2995a90a3e62.zip
68599-0213NUDERMRXPAK 120 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210506_a838204b-9564-9aa6-e053-2a95a90af02f.zip
68599-0213NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210511_a837f13e-fafc-0535-e053-2995a90a5070.zip
68599-0213NUSURGEPAK SURGICAL PREP/CAREPAK (CHLORHEXIDINE GLUCONATE, MUPIROCIN, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS INC]2Current NDC, Legacy NDC20200623_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 52 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact identifier
application number: M016
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
application number: M016
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
application number: M016
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
application number: M016
VITAMIN A and DVITAMIN A AND DALLIED TRADE LINK LLC26d426c3-4dfb-c984-e063-6394a90a37932024-11-13WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure ProgramALUMINUM ACETATEZO Skin Health, Inc.9786acc8-06ae-4f2b-9602-b7e8c3baeca52024-11-12WarningsExact identifier
application number: M016
DUKAL WHITE PETROLATUMPETROLATUMDukal LLC0c6474ed-2343-d5f2-e063-6394a90a30b32024-11-12WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSNa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamPSNa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSNa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 2 % Topical OintmentPSNa83a55e8-58df-ac57-e053-2a95a90a94252
313921calcipotriene 0.05 MG/ML Topical CreamSCDa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.05 MG/ML Topical CreamSCDa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCDa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 0.02 MG/MG Topical OintmentSCDa83a55e8-58df-ac57-e053-2a95a90a94252
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSYa83a55e8-58df-ac57-e053-2a95a90a94252
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSYa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 2 % Topical OintmentSYa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 20 MG per GM Topical OintmentSYa83a55e8-58df-ac57-e053-2a95a90a94252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0213-468599021304118 mg in 1 BOTTLE (68599-0213-4) 118 mg2019-08-120000-00-00NoNoCurrent