FDA.reportPublic FDA data

good sense tussin

Product NDC
0113-0061
Requested package NDC
0113-0061-26
11-digit product format
001130061
Labeler code
0113
Product ID
0113-0061_ccbca601-b066-4332-8c93-cf3b00677365
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1991-01-15
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
200 mg/10mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage0113-00610113-0061-26DDiscontinued by firm2026-08-11

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 · 6 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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0061-26ML - Milliliter0113-006179705216-54a8-4f70-be70-0a7fcb508cb212013-08-02
0113-0061-34ML - Milliliter0113-00617ab33c31-914c-42c8-91c2-b8b6e0759db612013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
GUAIFENESINACTIVE MOIETY495W7451VQGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
CARAMELINACTIVE INGREDIENTT9D99G2B1RGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
MALTOLINACTIVE INGREDIENT3A9RD92BS4GOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE TUSSIN MUCUS AND CHEST CONGESTION (GUAIFENESIN) SYRUP [L. PERRIGO COMPANY]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0061-26001130061261 BOTTLE in 1 CARTON (0113-0061-26) > 118 mL in 1 BOTTLE1 bottle1991-01-150000-00-00NoNoCurrent