FDA.reportPublic FDA data

38779-0696

Product NDC
38779-0696
11-digit product format
387790696
Labeler code
38779
Product ID
38779-0696_3bcbfea2-989f-8484-e063-6394a90a4b92
Type
BULK INGREDIENT
Nonproprietary name
Guaifenesin
Dosage form
POWDER
Marketing category
BULK INGREDIENT
Marketing start
2012-04-24
Substance
GUAIFENESIN
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct38779-0696UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-069638779-0696-1UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-069638779-0696-5UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-069638779-0696-7UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-069638779-0696-8UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-069638779-0696-9UNFINISHEDActive or certified unfinished drug listing2026-10-16

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 3 · 126 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 packagepackage38779-0696-7a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0696-8a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0696-9a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0696-1a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-0696-5a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0696-71d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0696-81d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0696-91d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0696-11d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-0696-51d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0696-7390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0696-5390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0696-1390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0696-8390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-0696-9390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0696-7e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0696-5e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0696-1e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0696-8e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-0696-9e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0696-7bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0696-5bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0696-1bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0696-8bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-0696-9bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0696-7f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0696-5f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0696-1f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0696-8f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-0696-9f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0696-7f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0696-5f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0696-1f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0696-8f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage38779-0696-9f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0696-768b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0696-568b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0696-168b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0696-868b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage38779-0696-968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0696-705c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0696-505c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0696-105c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0696-805c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage38779-0696-905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage38779-0696-748b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage38779-0696-548b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage38779-0696-148b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage38779-0696-848b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage38779-0696-948b4f40e6753…c7c7a00d2afa…

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
GUAIFENESIN1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
38779-0696-0GM - Gram38779-06965c3bc746-a6d0-4484-a979-1f50f3b38fce12013-02-19
38779-0696-1GM - Gram38779-0696548f71fb-8ef4-4730-ab53-42c2d634099e12013-02-19
38779-0696-5GM - Gram38779-0696e74eeaef-1443-413d-b3e1-83cffd09977e12013-02-19
38779-0696-7GM - Gram38779-0696287eed0e-bab5-468a-8bf3-7f2dfc38c9ce12013-02-19
38779-0696-8GM - Gram38779-069678f7802d-6df4-4fc7-9f49-b82cd48718d712013-02-19
38779-0696-9GM - Gram38779-06968d4e2b8b-3177-46c5-94f8-4dae2ab85c3812013-02-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
38779-0696-1387790696012500 g in 1 JAR (38779-0696-1)2500 g09-SEP-16Current
38779-0696-538779069605100 g in 1 JAR (38779-0696-5)100 g09-SEP-16Current
38779-0696-73877906960725000 g in 1 DRUM (38779-0696-7)25000 g09-SEP-16Current
38779-0696-838779069608500 g in 1 JAR (38779-0696-8)500 g09-SEP-16Current
38779-0696-9387790696091000 g in 1 JAR (38779-0696-9)1000 g09-SEP-16Current