Cold Relief

Product NDC
59779-941
11-digit product format
597790941
Labeler code
59779
Product ID
59779-941_9b4f6923-a888-40b0-aad3-2e91a5e18cca
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-31
Marketing end
2021-12-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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 productproduct59779-941DDiscontinued by firm2026-10-15
excluded packagepackage59779-94159779-941-08DDiscontinued 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 · 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 packagepackage59779-941-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-941-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-941-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-941-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-941-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-941-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-941-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-941-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-941-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-941-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-941-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-941-08557ba5c1ecfa…9c80585c8c6e…

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
59779-941-08ML - Milliliter59779-9416d383e0f-e67d-47e7-996b-ac68bd75c85d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
GUAIFENESINACTIVE MOIETY495W7451VQCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4COLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLD RELIEF MULTI SYMPTOM SEVERE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CVS PHARMACY]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-941-0859779094108237 mL in 1 BOTTLE, PLASTIC (59779-941-08) 237 ml2015-05-312021-12-31NoNoCurrent