FDA.reportPublic FDA data

Astonea Clotrimazole 1%

Product NDC
77338-312
Requested package NDC
77338-312-44
11-digit product format
773380312
Labeler code
77338
Product ID
77338-312_e673adba-8dd2-6610-e053-2a95a90a2f50
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-04
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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 packagepackage77338-31277338-312-44IInactivated by FDA2026-10-12

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
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-31277338-312-44IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-31277338-312-44IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-31277338-312-44IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
77338-312-442024-06-25Astonea Clotrimazole USP, 1%
77338-312-482024-06-25Astonea Clotrimazole USP, 1%
77338-312-442024-01-30Astonea Clotrimazole USP, 1%
77338-312-482024-01-30Astonea Clotrimazole USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-312-44Astonea Clotrimazole 1%Athletes Foot28.3 g in 1 TUBECREAM28.33
77338-312-48Astonea Clotrimazole 1%Athletes Foot113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-312ASTONEA CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 2 package rows20240627_e5d2b45a-26f2-14a9-e053-2a95a90a2456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNe5d2b45a-26f2-14a9-e053-2a95a90a24563
309367clotrimazole 10 MG/ML Topical CreamSCDe5d2b45a-26f2-14a9-e053-2a95a90a24563
309367clotrimazole 1 % Topical CreamSYe5d2b45a-26f2-14a9-e053-2a95a90a24563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-312-447733803124428.3 g in 1 TUBE (77338-312-44) 28.3 g2020-03-040000-00-00NoNoCurrent