dolodent toothache for adults

Generic: acetaminophen, caffeine

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dolodent toothache for adults
Generic Name acetaminophen, caffeine
Labeler pharmadel llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, caffeine 65 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-435
Product ID 55758-435_227ba7f7-a051-50ad-e063-6394a90a74d6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2024-07-30

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758435
Hyphenated Format 55758-435

Supplemental Identifiers

RxCUI
307686
UNII
362O9ITL9D 3G6A5W338E
NUI
N0000175739 N0000175729 N0000175790 M0023046

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dolodent toothache for adults (source: ndc)
Generic Name acetaminophen, caffeine (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 65 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE
source: ndc

Packages (1)

55758-435-24 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) caffeine (65 mg/1)

Linked Drug Pages (1)

DoloDent Toothache For adults ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "227ba7f7-a051-50ad-e063-6394a90a74d6", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E"], "rxcui": ["307686"], "spl_set_id": ["1e7a0c06-ad3c-b94f-e063-6394a90abab1"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55758-435-24)  / 24 TABLET in 1 BOTTLE", "package_ndc": "55758-435-24", "marketing_start_date": "20240730"}], "brand_name": "DoloDent Toothache For adults", "product_id": "55758-435_227ba7f7-a051-50ad-e063-6394a90a74d6", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "55758-435", "generic_name": "Acetaminophen, Caffeine", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DoloDent Toothache", "brand_name_suffix": "For adults", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "65 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240730", "listing_expiration_date": "20261231"}