Topcare pain and fever

Product NDC
36800-161
11-digit product format
368000161
Labeler code
36800
Product ID
36800-161_379dcaf6-995b-4e66-b09b-d0ddf0d4e571
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
2011-08-26
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 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
36800-161-10Topcare pain and fever1 in 1 CARTONSUSPENSION18
36800-161-10Topcare pain and fever30 mL in 1 BOTTLESUSPENSION308
36800-161-16Topcare pain and fever1 in 1 CARTONSUSPENSION18
36800-161-16Topcare pain and fever59 mL in 1 BOTTLESUSPENSION598

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-161TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 4 package rows20240716_950b16d5-65db-402d-8ec6-eec9e1e174dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668acetaminophen 32 MG/ML Oral SuspensionSCD950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY950b16d5-65db-402d-8ec6-eec9e1e174dd8
307668APAP 32 MG/ML Oral SuspensionSY950b16d5-65db-402d-8ec6-eec9e1e174dd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-161-10368000161101 BOTTLE in 1 CARTON (36800-161-10) / 30 mL in 1 BOTTLE1 bottle2011-08-260000-00-00NoNoCurrent
36800-161-16368000161161 BOTTLE in 1 CARTON (36800-161-16) > 59 mL in 1 BOTTLE1 bottle2012-04-100000-00-00NoNoCurrent