FDA.reportPublic FDA data

ASTONEA XERO

Product NDC
77338-022
11-digit product format
773380022
Labeler code
77338
Product ID
77338-022_ef04fca0-f72b-2ab5-e053-2995a90ad253
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-18
Marketing end
0000-00-00
Substance
DIMETHICONE; ZINC OXIDE
Active strength
1 g/100g; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77338-022IInactivated by FDA2026-10-05
excluded packagepackage77338-02277338-022-23IInactivated 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-022-238af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-022-23834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-022-231332a3947898…d4bfe170f9cd…

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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-022-232024-06-25C16284748780-11030e365-0c7f-111a-e063-dadaa90a10e2ASTONEA XERO
77338-022-232024-01-30C16284748780-11030e365-0c7f-111a-e063-dadaa90a10e2ASTONEA XERO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-022-23ASTONEA XERO113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-022ASTONEA XERO (SKIN PROTECTANT) OINTMENT [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 1 package rows20240627_e69ab651-9f37-8cb8-e053-2a95a90a88e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2609848dimethicone 1 % / zinc oxide 15 % Topical OintmentPSNe69ab651-9f37-8cb8-e053-2a95a90a88e33
2609848dimethicone 0.01 MG/MG / zinc oxide 0.15 MG/MG Topical OintmentSCDe69ab651-9f37-8cb8-e053-2a95a90a88e33
2609848dimethicone 0.01 MG/MG / ZNO 0.15 MG/MG Topical OintmentSYe69ab651-9f37-8cb8-e053-2a95a90a88e33
2609848dimethicone 1 % / zinc oxide 15 % Topical OintmentSYe69ab651-9f37-8cb8-e053-2a95a90a88e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-022-2377338002223113 g in 1 TUBE (77338-022-23) 113 g2022-08-180000-00-00NoNoCurrent