Mucus Relief

Product NDC
71679-075
Requested package NDC
71679-075-00
11-digit product format
716790075
Labeler code
71679
Product ID
71679-075_b47ca14b-de55-4688-e053-2995a90ae019
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400 mg
Dosage form
TABLET
Route
ORAL
Labeler
Health Pharma USA LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-13
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
400 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage71679-07571679-075-00DDiscontinued by firm2026-10-05

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71679-075-002023-01-13C16284748780-1d6a99b39-b336-a426-e053-dadaa90af4c2Guaifenesin 400 mg Caplets
71679-075-002022-01-28C16284748780-1d6a99b39-b336-a426-e053-dadaa90af4c2Guaifenesin 400 mg Caplets

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71679-075-00716790075001 BAG in 1 BOX (71679-075-00) > 36960 TABLET in 1 BAG1 bag2016-04-130000-00-00NoNoCurrent