FDA.reportPublic FDA data

38779-0019

Product NDC
38779-0019
11-digit product format
387790019
Labeler code
38779
Product ID
38779-0019_436d9ee3-d08c-5d7d-e063-6294a90afafe
Type
BULK INGREDIENT
Nonproprietary name
Clotrimazole
Dosage form
POWDER
Marketing category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start
2013-03-21
Substance
CLOTRIMAZOLE
Active strength
1 g/g
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct38779-0019UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-1UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-3UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-4UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-5UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-8UNFINISHEDActive or certified unfinished drug listing2026-10-15
unfinished packagepackage38779-001938779-0019-9UNFINISHEDActive or certified unfinished drug listing2026-10-15

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 3 · 147 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-1a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-8a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-9a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-3a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-5a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0019-4a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-41d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-51d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-81d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-91d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-11d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0019-31d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-4390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-5390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-8390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-9390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-1390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0019-3390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-4e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-5e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-8e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-9e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-1e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0019-3e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-4bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-5bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-8bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-9bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-1bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0019-3bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-4f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-5f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-8f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-9f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-1f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0019-3f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-4f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-5f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-8f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-9f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-1f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0019-3f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-468b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-568b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-868b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-968b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-168b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0019-368b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0019-405c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0019-505c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0019-805c55d027831…ca05dca9dc4c…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
38779-0019-1GM - Gram38779-0019d7c93da8-89ee-4dcb-ac28-47e71c0ceaea12013-04-01
38779-0019-3GM - Gram38779-001979444092-b3df-4c39-a4cb-b3468408792912013-04-01
38779-0019-4GM - Gram38779-00194d04d56a-5ff0-4278-be16-bbf37c2f8a5612013-04-01
38779-0019-5GM - Gram38779-001979ebff1c-c796-4c2d-8d16-cb80871b3aef12013-04-01
38779-0019-8GM - Gram38779-0019d6e9c93e-db8a-4596-b36f-07229546baff12013-04-01
38779-0019-9GM - Gram38779-001908bac9ce-9cb3-4452-ba28-e1be2b1e4fd612013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
38779-0019-13877900190110 g in 1 JAR (38779-0019-1)10 g21-MAR-13Current
38779-0019-3387790019035 g in 1 BOTTLE, GLASS (38779-0019-3)5 g21-MAR-13Current
38779-0019-43877900190425 g in 1 JAR (38779-0019-4)25 g21-MAR-13Current
38779-0019-538779001905100 g in 1 JAR (38779-0019-5)100 g21-MAR-13Current
38779-0019-838779001908500 g in 1 JAR (38779-0019-8)500 g21-MAR-13Current
38779-0019-9387790019091000 g in 1 JAR (38779-0019-9)1000 g21-MAR-13Current