FDA.reportPublic FDA data

topcare childrens pain and fever

Product NDC
36800-959
11-digit product format
368000959
Labeler code
36800
Product ID
36800-959_5a1d619f-48d2-4832-a4f7-1c6a72591094
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-02-27
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-959IInactivated by FDA2026-10-15
excluded packagepackage36800-95936800-959-26IInactivated by FDA2026-10-15

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 · 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
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct36800-959DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-95936800-959-26DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-959-26topcare childrens pain and fever118 mL in 1 BOTTLESUSPENSION1189
36800-959-26topcare childrens pain and fever1 in 1 CARTONSUSPENSION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-959-26ML - Milliliter36800-95900874fca-64d1-4621-99e1-bfa31405fbdb12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-959TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]9Legacy NDC, 2 package rows20240913_9e60d975-7cdc-4ada-9d78-b0e279ad5ab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668acetaminophen 32 MG/ML Oral SuspensionSCD9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY9e60d975-7cdc-4ada-9d78-b0e279ad5ab09
307668APAP 32 MG/ML Oral SuspensionSY9e60d975-7cdc-4ada-9d78-b0e279ad5ab09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-959-26368000959261 BOTTLE in 1 CARTON (36800-959-26) > 118 mL in 1 BOTTLE1 bottle2012-02-270000-00-00NoNoCurrent