FDA.reportPublic FDA data

Tussin

Product NDC
68016-020
Requested package NDC
68016-020-04
11-digit product format
680160020
Labeler code
68016
Product ID
68016-020_6c481e28-ed5e-4b5e-8f55-0e43b0623920
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-09-07
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
100 mg/5mL
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 packagepackage68016-02068016-020-04DDiscontinued 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 · 14 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…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
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…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68016-020-042022-12-18a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082022-12-18a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042022-01-28a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082022-01-28a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042020-12-31a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082020-12-31a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-042020-01-31a6ce674a-df4e-4172-8171-bbab0b53c8d2
68016-020-082020-01-31a6ce674a-df4e-4172-8171-bbab0b53c8d2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-020-04ML - Milliliter68016-0209e178b9a-584e-4a73-af1f-0cc3f16cf3b712014-07-02
68016-020-08ML - Milliliter68016-020bbffb260-fb3b-4ed5-82f4-ec3de4b5524612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
CARAMELINACTIVE INGREDIENTT9D99G2B1RTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-020-0468016002004118 mL in 1 BOTTLE, PLASTIC (68016-020-04) 118 ml2012-09-070000-00-00NoNoCurrent