Home NDC 52389-253 BackAid
Product NDC 52389-253
11-digit product format 523890253
Labeler code 52389
Product ID 52389-253_41aea851-bb73-0113-e063-6294a90a245f
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kobayashi Healthcare International, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-31
Substance CAFFEINE; ACETAMINOPHEN
Active strength 75; 500 mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 BackAid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 75 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52389-253-14 BackAid 1 in 1 CARTON TABLET, FILM COATED 1 2 52389-253-14 BackAid 14 in 1 BLISTER PACK TABLET, FILM COATED 14 2 52389-253-28 BackAid 2 in 1 CARTON TABLET, FILM COATED 2 2 52389-253-28 BackAid 14 in 1 BLISTER PACK TABLET, FILM COATED 14 2 52389-253-38 BackAid 38 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 38 2 52389-253-38 BackAid 1 in 1 CARTON TABLET, FILM COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-253 BACKAID (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 1 Current NDC, 6 package rows 20241211_25db6bb5-96b6-4be1-e063-6294a90a2300.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 1 of 83 · 1,657 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52389-253-14 52389025314 1 BLISTER PACK in 1 CARTON (52389-253-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2024-12-11 No No Current 52389-253-28 52389025328 2 BLISTER PACK in 1 CARTON (52389-253-28) / 14 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-12-11 No No Current 52389-253-38 52389025338 1 BOTTLE, PLASTIC in 1 CARTON (52389-253-38) / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-12-11 No No Current