FDA.reportPublic FDA data

infants pain and fever

Product NDC
59779-946
Requested package NDC
59779-946-10
11-digit product format
597790946
Labeler code
59779
Product ID
59779-946_8d40ef34-c780-4ecb-9f5a-457e95cedb4e
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
2011-12-14
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-94659779-946-10DDiscontinued 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-94659779-946-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-94659779-946-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
59779-946-10ML - Milliliter59779-946ab6fab45-a46d-4d91-a94c-db99404b3fc612021-09-07
59779-946-16ML - Milliliter59779-946f34e1144-4ef0-4136-8655-89cc4036d66c12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-946INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]8Legacy NDC20240719_7e16b941-861d-43cc-a710-d880b051a98f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-946-10597790946101 BOTTLE in 1 CARTON (59779-946-10) > 30 mL in 1 BOTTLE1 bottle2011-12-140000-00-00NoNoCurrent