FDA.reportPublic FDA data

Flu and Sore Throat

Product NDC
59779-938
Requested package NDC
59779-938-08
11-digit product format
597790938
Labeler code
59779
Product ID
59779-938_4d4b008d-b2c8-48aa-9986-9f179f4d428c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
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; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-93859779-938-08DDiscontinued by firm2026-10-12

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 · 12 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…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
59779-938-08ML - Milliliter59779-938fa984ae7-e255-4a42-9af9-38404ad2681c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
MALTITOLINACTIVE INGREDIENTD65DG142WKFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RFLU AND SORE THROAT (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-938-0859779093808245 mL in 1 BOTTLE, PLASTIC (59779-938-08) 245 ml2015-05-312021-12-31NoNoCurrent