Home NDC 55758-435 DoloDent Toothache
Product NDC 55758-435
11-digit product format 557580435
Labeler code 55758
Product ID 55758-435_227ba7f7-a051-50ad-e063-6394a90a74d6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine
Dosage form TABLET
Route ORAL
Labeler Pharmadel LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-30
Substance CAFFEINE; ACETAMINOPHEN
Active strength 65; 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 DoloDent Toothache
Brand name suffix For adults
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 65 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307686 Internal RxNorm 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 55758-435-24 DoloDent ToothacheFor adults 1 in 1 CARTON TABLET 1 5 55758-435-24 DoloDent ToothacheFor adults 24 in 1 BOTTLE TABLET 24 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-435 DOLODENT TOOTHACHE FOR ADULTS (ACETAMINOPHEN, CAFFEINE) TABLET [PHARMADEL LLC] 5 Current NDC, 2 package rows 20240922_1e7a0c06-ad3c-b94f-e063-6394a90abab1.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 79 · 1,579 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 55758-435-24 55758043524 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE 1 bottle 2024-07-30 No No Current