topcare childrens pain and fever

Product NDC
36800-202
11-digit product format
368000202
Labeler code
36800
Product ID
36800-202_f5d35fd8-953d-48b6-a7a2-a79a9c3408db
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-01-15
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topcare childrens pain and fever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-202-00topcare childrens pain and fever236 mL in 1 BOTTLESUSPENSION23611
36800-202-00topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-26topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-26topcare childrens pain and fever118 mL in 1 BOTTLESUSPENSION11811
36800-202-28topcare childrens pain and fever148 mL in 1 BOTTLESUSPENSION14811
36800-202-28topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-34topcare childrens pain and fever118 mL in 1 BOTTLESUSPENSION11811
36800-202-34topcare childrens pain and fever2 in 1 CARTONSUSPENSION211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-202-26ML - Milliliter36800-20212f916a1-ae01-4778-9bd5-b224d4851d5012017-10-13

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
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TOPCARE 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
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE 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
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
36800-202TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]10Current NDC, Legacy NDC, 8 package rows20241004_911492d5-e065-4b8f-b2dc-cb6a6678d0ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668acetaminophen 32 MG/ML Oral SuspensionSCD911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY911492d5-e065-4b8f-b2dc-cb6a6678d0ae11
307668APAP 32 MG/ML Oral SuspensionSY911492d5-e065-4b8f-b2dc-cb6a6678d0ae11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-202-00368000202001 BOTTLE in 1 CARTON (36800-202-00) / 236 mL in 1 BOTTLE1 bottle2024-01-30NoNoHistorical
36800-202-26368000202261 BOTTLE in 1 CARTON (36800-202-26) / 118 mL in 1 BOTTLE1 bottle1992-07-200000-00-00NoNoCurrent
36800-202-28368000202281 BOTTLE in 1 CARTON (36800-202-28) > 148 mL in 1 BOTTLE1 bottle2013-03-080000-00-00NoNoCurrent
36800-202-34368000202342 BOTTLE in 1 CARTON (36800-202-34) > 118 mL in 1 BOTTLE2 bottle2017-10-110000-00-00NoNoCurrent