FDA.reportPublic FDA data

Topcare Tussin

Product NDC
36800-300
Requested package NDC
36800-300-26
11-digit product format
368000300
Labeler code
36800
Product ID
36800-300_c5589361-9f74-4b6e-8521-22255a5cfd94
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1992-10-21
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage36800-30036800-300-26DDiscontinued by firm2026-10-15

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 · 10 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-300-26ML - Milliliter36800-3008fbceda3-f9e0-4b9d-b950-193dd057c2c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [TOPCO ASSOCIATES LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-300-26368000300261 BOTTLE in 1 CARTON (36800-300-26) > 118 mL in 1 BOTTLE1 bottle1992-10-210000-00-00NoNoCurrent