FDA.reportPublic FDA data

ASTONEA GREEN gel

Product NDC
77338-015
11-digit product format
773380015
Labeler code
77338
Product ID
77338-015_e8199804-b552-a97e-e053-2a95a90a92aa
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-09-19
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/100g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77338-015IInactivated by FDA2026-10-05
excluded packagepackage77338-01577338-015-63IInactivated by FDA2026-10-05
excluded packagepackage77338-01577338-015-65IInactivated by FDA2026-10-05
excluded packagepackage77338-01577338-015-67IInactivated 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 · 12 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 packagepackage77338-015-678af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-015-658af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-015-638af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-015-67834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-015-65834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-015-63834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-015-671332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-015-651332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-015-631332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
77338-015-632026-01-29ASTONEA GREEN PAIN GEL
77338-015-652026-01-29ASTONEA GREEN PAIN GEL
77338-015-672026-01-29ASTONEA GREEN PAIN GEL
77338-015-632024-06-25ASTONEA GREEN PAIN GEL
77338-015-652024-06-25ASTONEA GREEN PAIN GEL
77338-015-672024-06-25ASTONEA GREEN PAIN GEL
77338-015-632024-01-30ASTONEA GREEN PAIN GEL
77338-015-652024-01-30ASTONEA GREEN PAIN GEL
77338-015-672024-01-30ASTONEA GREEN PAIN GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-015-63ASTONEA GREEN gel2.9 g in 1 POUCHGEL2.93
77338-015-65ASTONEA GREEN gel113 g in 1 TUBEGEL1133
77338-015-67ASTONEA GREEN gel907 g in 1 BOTTLE, DISPENSINGGEL9073

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-015ASTONEA GREEN GEL (MENTHOL) GEL [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 3 package rows20240627_e69c2450-d16a-d5dc-e053-2995a90ab34d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415975menthol 5 % Topical GelPSNe69c2450-d16a-d5dc-e053-2995a90ab34d3
415975menthol 0.05 MG/MG Topical GelSCDe69c2450-d16a-d5dc-e053-2995a90ab34d3
415975menthol 5 % Topical GelSYe69c2450-d16a-d5dc-e053-2995a90ab34d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-015-63773380015632.9 g in 1 POUCH (77338-015-63) 2.9 g2016-09-190000-00-00NoNoCurrent
77338-015-6577338001565113 g in 1 TUBE (77338-015-65) 113 g2022-08-190000-00-00NoNoCurrent
77338-015-6777338001567907 g in 1 BOTTLE, DISPENSING (77338-015-67) 907 g2022-08-190000-00-00NoNoCurrent