VMV HYPOALLERGENICS ARMADA 30

Product NDC
69774-536
11-digit product format
697740536
Labeler code
69774
Product ID
69774-536_14ebd3fc-e74c-226f-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SKIN SCIENCES LABORATORY INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; OCTISALATE; ENSULIZOLE; ZINC OXIDE
Active strength
1 g/85g; g/85g; g/85g; g/85g
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69774-536IInactivated by FDA2026-09-14
excluded packagepackage69774-53669774-536-63IInactivated by FDA2026-09-14

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69774-536-63IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69774-536-63IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69774-536-63IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69774-536-63IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69774-536-63IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69774-536-63IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69774-536-63IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69774-536-63IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69774-536-63IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69774-536-63IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69774-536-63IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69774-536-63IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69774-536-63IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69774-536-63IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69774-536-63IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69774-536-63IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69774-536-63IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69774-536-63IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69774-536-63IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69774-536-63IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69774-536-63IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69774-536-63EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69774-536-632020-01-31C16284748780-19d75b9d0-4519-f424-e053-dadaa90a57ce14ebd3fc-e74b-226f-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69774-536-63VMV HYPOALLERGENICS ARMADA 301 g in 1 TUBECREAM11
69774-536-63VMV HYPOALLERGENICS ARMADA 301 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42VMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42VMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RVMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69774-536VMV HYPOALLERGENICS ARMADA 30 (ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN SCIENCES LABORATORY INC.]1Legacy NDC, 2 package rows20150507_14ebd3fc-e74b-226f-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69774-536-63697740536631 g in 1 TUBE1 gHistorical