FDA.reportPublic FDA data

childrens pain and fever

Product NDC
59779-263
11-digit product format
597790263
Labeler code
59779
Product ID
59779-263_4205cd89-6763-4437-83b9-f8b30d64ec87
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS Pharmacy
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1991-06-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct59779-263DDiscontinued by firm2026-10-05
excluded packagepackage59779-26359779-263-26DDiscontinued by firm2026-10-05
excluded packagepackage59779-26359779-263-28DDiscontinued by firm2026-10-05

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
59779-263-26ML - Milliliter59779-26357a32059-ef68-4a37-8b18-e6ddde14dc6b12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-263CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]11Legacy NDC20241006_dcf7994b-2522-4df4-ba4e-cb521a4ff0ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-263-26597790263261 BOTTLE in 1 CARTON (59779-263-26) > 118 mL in 1 BOTTLE1 bottle1991-06-150000-00-00NoNoCurrent