FDA.reportPublic FDA data

Tussin

Product NDC
68071-2663
Requested package NDC
68071-2663-4
11-digit product format
680712663
Labeler code
68071
Product ID
68071-2663_db4a5925-e865-42ba-e053-2a95a90ad381
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-17
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 packagepackage68071-266368071-2663-4IInactivated 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 · 9 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 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2663-42025-01-30C16284748780-12cef2736-8746-d83d-e063-dadaa90ab31fMcKesson Adult Tussin Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2663-4Tussin118 mL in 1 BOTTLESOLUTION1181
68071-2663-4Tussin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2663TUSSIN (GUAIFENESIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220329_db4a5925-e864-42ba-e053-2a95a90ad381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 20 MG/ML Oral SolutionSCDdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 100 MG per 5 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 100 MG per 5 ML Oral SyrupSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 200 MG per 10 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 300 MG per 15 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811
310604guaifenesin 400 MG per 20 ML Oral SolutionSYdb4a5925-e864-42ba-e053-2a95a90ad3811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2663-4680712663041 BOTTLE in 1 CARTON (68071-2663-4) > 118 mL in 1 BOTTLE1 bottle2022-03-280000-00-00NoNoCurrent