FDA.reportPublic FDA data

Diabetic Tussin Expectorant

Product NDC
61787-514
Requested package NDC
61787-514-04
11-digit product format
617870514
Labeler code
61787
Product ID
61787-514_27e059a5-ece3-4fa7-8f12-59ae0c21bdd4
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
MEDTECH PRODUCTS INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-01
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 packagepackage61787-51461787-514-04IInactivated 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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
61787-514-042024-07-30C16284748780-11030e365-5fc2-111a-e063-dadaa90a10e2Diabetic Tussin Expectorant 61787 514
61787-514-042024-01-30C16284748780-11030e365-5fc2-111a-e063-dadaa90a10e2Diabetic Tussin Expectorant 61787 514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61787-514-04Diabetic Tussin Expectorant118 mL in 1 BOTTLELIQUID1183
61787-514-04Diabetic Tussin Expectorant1 in 1 BOXLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-514-04ML - Milliliter61787-514d4538812-5eee-4755-9381-e3a0ed7f105712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61787-514DIABETIC TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [MEDTECH PRODUCTS INC]3Legacy NDC, 2 package rows20220303_d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992212Diabetic Tussin Expectorant 100 MG in 5 mL Oral SolutionPSNd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
992212guaifenesin 20 MG/ML Oral Solution [Diabetic Tussin EX]SBDd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 20 MG/ML Oral SolutionSCDd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
992212Diabetic Tussin EX 20 MG/ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
992212Diabetic Tussin Expectorant 100 MG per 5 ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
992212Diabetic Tussin Mucus Relief 20 MG/ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 100 MG per 5 ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 100 MG per 5 ML Oral SyrupSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 200 MG per 10 ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 300 MG per 15 ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3
310604guaifenesin 400 MG per 20 ML Oral SolutionSYd65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61787-514-04617870514041 BOTTLE in 1 BOX (61787-514-04) > 118 mL in 1 BOTTLE1 bottle2020-02-010000-00-00NoNoCurrent