FDA.reportPublic FDA data

health mart adult tussin

Product NDC
62011-0092
11-digit product format
620110092
Labeler code
62011
Product ID
62011-0092_680d0db2-ed1b-453b-bedb-bc12ba84f890
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-11
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0092DDiscontinued by firm2026-10-16
excluded packagepackage62011-009262011-0092-1DDiscontinued by firm2026-10-16
excluded packagepackage62011-009262011-0092-2DDiscontinued by firm2026-10-16

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0092-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0092-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0092-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0092-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0092-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0092-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0092-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0092-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0092-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0092-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0092-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0092-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0092-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0092-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0092-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0092-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0092-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0092-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0092-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0092-1ad56d346431e…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
62011-0092-1ML - Milliliter62011-00924787c29c-b02f-44d6-91fe-14d1c2c8126012012-07-24
62011-0092-2ML - Milliliter62011-00924b328eba-1f61-4329-9744-9f95f9e0337012014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
GUAIFENESINACTIVE INGREDIENT495W7451VQHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
GUAIFENESINACTIVE MOIETY495W7451VQHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1HEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3AHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5
WATERINACTIVE INGREDIENT059QF0KO0RHEALTH MART ADULT TUSSIN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MCKESSON]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0092-1620110092011 BOTTLE in 1 CARTON (62011-0092-1) > 118 mL in 1 BOTTLE1 bottle2012-01-110000-00-00NoNoCurrent
62011-0092-2620110092021 BOTTLE in 1 CARTON (62011-0092-2) > 237 mL in 1 BOTTLE1 bottle2013-08-210000-00-00NoNoCurrent