FDA.reportPublic FDA data

Benchmarks Derma Shield

Product NDC
70557-002
Requested package NDC
70557-002-03
11-digit product format
705570002
Labeler code
70557
Product ID
70557-002_ea3c10e9-e21e-d6c4-e053-2a95a90ac5dc
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
AEROSOL
Route
TOPICAL
Labeler
Delta Kits Inc
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-27
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
3 g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70557-00270557-002-03IInactivated by FDA2026-10-05

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
70557-002-012024-07-30c7ccaba7-248d-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-022024-07-30c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-032024-07-30c7ccaba7-2490-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-022021-08-30c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-012021-08-26c7ccaba7-248d-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-032021-08-26c7ccaba7-2490-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-012021-07-23c7ccaba7-248d-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-022021-07-23c7ccaba7-20eb-fd44-e053-dadaa90aa01bBenchmarks Derma Shield
70557-002-032021-07-23c7ccaba7-2490-fd44-e053-dadaa90aa01bBenchmarks Derma Shield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70557-002-01Benchmarks Derma Shield57 g in 1 CANAEROSOL5714
70557-002-02Benchmarks Derma Shield170 g in 1 CANAEROSOL17010
70557-002-03Benchmarks Derma Shield482 g in 1 CANAEROSOL4829

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70557-002BENCHMARKS DERMA SHIELD (DIMETHICONE) AEROSOL [DELTA KITS INC]14Legacy NDC, 1 package rows20231003_2ea845e6-4086-574d-e054-00144ff88e88.zip
70557-002BENCHMARKS DERMA SHIELD (DIMETHICONE) AEROSOL [DELTA KITS INC]10Legacy NDC, 1 package rows20231003_31806176-9d68-0066-e054-00144ff88e88.zip
70557-002BENCHMARKS DERMA SHIELD (DIMETHICONE) AEROSOL [DELTA KITS INC]9Legacy NDC, 1 package rows20231003_31806176-9d6d-0066-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70557-002-0370557000203482 g in 1 CAN (70557-002-03) 482 g2016-04-270000-00-00NoNoCurrent