Home NDC 52412-912 Fast Acting
Product NDC 52412-912
11-digit product format 524120912
Labeler code 52412
Product ID 52412-912_58c4e189-872b-fd9d-e063-6294a90a100c
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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fast Acting
Brand name suffix Pedia Crae
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52412-912-01 Fast ActingPedia Crae 30 mL in 1 BOTTLE SUSPENSION 30 3 52412-912-01 Fast ActingPedia Crae 1 in 1 CARTON SUSPENSION 1 3 52412-912-04 Fast ActingPedia Crae 118 mL in 1 BOTTLE SUSPENSION 118 3 52412-912-04 Fast ActingPedia Crae 1 in 1 CARTON SUSPENSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-912 FAST ACTING PEDIA CRAE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS., LTD.] 2 Current NDC, 4 package rows 20240823_e069060f-fbb2-4c7a-b872-00b3ab86d01b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 68 of 79 · 1,561 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52412-912-01 52412091201 1 BOTTLE in 1 CARTON (52412-912-01) / 30 mL in 1 BOTTLE 1 bottle 2023-05-26 No No Current 52412-912-04 52412091204 1 BOTTLE in 1 CARTON (52412-912-04) / 118 mL in 1 BOTTLE 1 bottle 2023-05-26 No No Current