Childrens Mucus Relief Cough Cherry

Product NDC
49580-3304
11-digit product format
495803304
Labeler code
49580
Product ID
49580-3304_122194e9-2524-4f1a-be2a-326b0805d1d7
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-02-03
Marketing end
2021-12-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct49580-3304DDiscontinued by firm2026-10-16
excluded packagepackage49580-330449580-3304-4DDiscontinued 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 · 24 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 packagepackage49580-3304-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49580-3304-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49580-3304-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49580-3304-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49580-3304-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49580-3304-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49580-3304-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49580-3304-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49580-3304-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49580-3304-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49580-3304-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49580-3304-4557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602CHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS MUCUS RELIEF COUGH CHERRY (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [AARON INDUSTRIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-3304-449580330404118 mL in 1 BOTTLE, PLASTIC (49580-3304-4) 118 ml2009-02-032021-12-30NoNoCurrent