FDA.reportPublic FDA data

Dermovix

Product NDC
69440-009
Requested package NDC
69440-009-15
11-digit product format
694400009
Labeler code
69440
Product ID
69440-009_8546bcf1-481e-4142-87f3-0c95fb3927b1
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin,Petrolatum
Dosage form
PATCH
Route
TOPICAL
Labeler
Binger Consulting Corporation
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
ALLANTOIN; PETROLATUM
Active strength
2 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage69440-00969440-009-15IInactivated by FDA2026-10-16

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69440-00969440-009-15IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69440-00969440-009-15IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69440-00969440-009-15EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69440-009-152021-10-21C16284748780-19d75b9d0-19cf-f424-e053-dadaa90a57ceDermovix
69440-009-152020-01-31C16284748780-19d75b9d0-19cf-f424-e053-dadaa90a57ceDermovix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69440-009-15Dermovix15 in 1 BOXPATCH154
69440-009-15Dermovix100 g in 1 PATCHPATCH1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69440-009-15EA - Each69440-009f2fd9e41-9496-445c-949b-3129d83f8b0e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZDERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UDERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
ALLANTOINACTIVE MOIETY344S277G0ZDERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
PETROLATUMACTIVE MOIETY4T6H12BN9UDERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1DERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
LIDOCAINEINACTIVE INGREDIENT98PI200987DERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2
ONIONINACTIVE INGREDIENT492225Q21HDERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69440-009DERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]4Legacy NDC, 2 package rows20241129_33139e68-3714-41e8-a3a7-24f28e8b409b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648752petrolatum 30 % Medicated PatchPSN33139e68-3714-41e8-a3a7-24f28e8b409b4
1648752petrolatum 0.3 MG/MG Medicated PatchSCD33139e68-3714-41e8-a3a7-24f28e8b409b4
1648752petrolatum 30 % Medicated PatchSY33139e68-3714-41e8-a3a7-24f28e8b409b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69440-009-156944000091515 PATCH in 1 BOX (69440-009-15) > 100 g in 1 PATCH15 patch2015-01-010000-00-00NoNoCurrent