FDA.reportPublic FDA data

Fast Acting

Product NDC
52412-912
11-digit product format
524120912
Labeler code
52412
Product ID
52412-912_3c3e1fe4-dc09-9745-e063-6394a90a7628
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Randob Labs., Ltd.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-26
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
Fast Acting
Brand name suffix
Pedia Crae
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
52412-912-01Fast ActingPedia Crae30 mL in 1 BOTTLESUSPENSION303
52412-912-01Fast ActingPedia Crae1 in 1 CARTONSUSPENSION13
52412-912-04Fast ActingPedia Crae118 mL in 1 BOTTLESUSPENSION1183
52412-912-04Fast ActingPedia Crae1 in 1 CARTONSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-912FAST ACTING PEDIA CRAE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS., LTD.]2Current NDC, 4 package rows20240823_e069060f-fbb2-4c7a-b872-00b3ab86d01b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668acetaminophen 32 MG/ML Oral SuspensionSCDe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYe069060f-fbb2-4c7a-b872-00b3ab86d01b3
307668APAP 32 MG/ML Oral SuspensionSYe069060f-fbb2-4c7a-b872-00b3ab86d01b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52412-912-01524120912011 BOTTLE in 1 CARTON (52412-912-01) / 30 mL in 1 BOTTLE1 bottle2023-05-26NoNoCurrent
52412-912-04524120912041 BOTTLE in 1 CARTON (52412-912-04) / 118 mL in 1 BOTTLE1 bottle2023-05-26NoNoCurrent