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 75 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alka-Seltzer BUFFERED ASPIRIN Lil' Drug Store Products, Inc. 0c7a60e7-0bde-9aa2-e063-6294a90a3209 2023-12-14 Warnings Exact identifier application number: M013 Circle K Aspirin 325 ASPIRIN Lil Drug Store Products, Inc 4cd306e3-2119-4272-9da4-a848fe2746fa 2023-12-14 Warnings Exact identifier application number: M013 Circle K Pain Reliever Extra Strength ACETAMINOPHEN Lil' Drug Store Products, Inc. f2359bc3-901f-4ecb-b402-cb2fe404a935 2023-12-14 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART c55b8f9d-1396-43c0-acc9-5e3485eadb07 2023-12-08 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 775519ad-5683-451f-9bfc-5fafc70c68ec 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. c20c814b-35f5-4c46-e053-2a95a90a50f2 2023-12-08 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Better Living Brands LLC f9859be4-6d0b-2ab8-e053-6294a90aa862 2023-12-06 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN KROGER COMPANY b9b7b849-c3b3-9af7-e053-2a95a90a0077 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN KROGER COMPANY cf649478-57d2-cc88-e053-2a95a90ad1ba 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b9b6f878-1ec8-3dc0-e053-2995a90a5414 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 2023-12-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREEN CO. cc939a7c-ce56-5dd6-e053-2995a90aa8af 2023-12-06 Warnings Exact identifier application number: M013 Alka-Seltzer Original Flavor BUFFERED ASPIRIN, EFFERVESCENT TABLET Lil' Drug Store Products, Inc. ea5df8be-a08c-5fa3-e053-2995a90a0bac 2023-12-06 Warnings Exact identifier application number: M013 Ringl ACETAMINOPHEN Sato Pharmaceutical Co., Ltd. ba5a0286-3e0f-4bef-96e5-29d92f51f432 2023-12-06 Warnings Exact identifier application number: M013 Pain Relief Childrens ACETAMINOPHEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 41633554-474e-4d3c-9187-d90487d2ae8c 2023-12-06 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC f86dcbb8-debc-4bce-e053-6294a90a7a02 2023-12-05 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR Pharmadel LLC 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 402c8563-b14b-453f-80bc-4275f1c73702 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Aurohealth LLC 3ba51b52-7ae6-4335-b178-1b7b6ef36227 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC bc03fa56-8880-4bbd-81a0-91853fecdd4e 2023-11-29 Warnings Exact identifier application number: M013
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