DR. SANA PAIN AND FEVER FOR Children

Product NDC
53113-516
11-digit product format
531130516
Labeler code
53113
Product ID
53113-516_d3ebeaac-ec26-4f27-be5d-739918117f2f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SYRUP
Route
ORAL
Labeler
GADAL Laboratories, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-14
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
DR. SANA PAIN AND FEVER FOR Children
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-516-06DR. SANA PAIN AND FEVER FOR Children1 in 1 BOXSYRUP12
53113-516-06DR. SANA PAIN AND FEVER FOR Children180 mL in 1 BOTTLESYRUP1802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 32 MG/ML Oral SolutionSCD8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 160 MG per 5 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612
307675APAP 32 MG/ML Oral SolutionSY8a22a5ba-8623-4cca-8723-52b4954034612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53113-516-06531130516061 BOTTLE in 1 BOX (53113-516-06) / 180 mL in 1 BOTTLE1 bottle2025-04-14NoNoCurrent