Sun Mark Mucus Relief Cough

Product NDC
49348-828
11-digit product format
493480828
Labeler code
49348
Product ID
49348-828_27e91d77-b359-4ce8-952b-a813f1817e84
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-10-12
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5 mg/5mL; mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-828DDiscontinued by firm2026-08-11
excluded packagepackage49348-82849348-828-34DDiscontinued 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 · 20 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 packagepackage49348-828-34d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-828-34f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-828-342ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-828-34a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-828-34cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-828-34cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-828-34302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-828-34ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-828-340efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-828-34ad56d346431e…cc804d4bbf1e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-828-34ML - Milliliter49348-8287177b250-30a7-4120-be77-2c5316d4aadd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
GUAIFENESINACTIVE INGREDIENT495W7451VQSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
GUAIFENESINACTIVE MOIETY495W7451VQSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9SUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
SORBITOLINACTIVE INGREDIENT506T60A25RSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RSUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESUN MARK MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [MCKESSON]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-828-34493480828341 BOTTLE in 1 CARTON (49348-828-34) > 118 mL in 1 BOTTLE1 bottle2007-10-120000-00-00NoNoCurrent