DoloDent Toothache For adults Acetaminophen, Caffeine 65 mg; 500 mg Tablet, 24-count
by Pharmadel LLC · 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE
NDC 55758-0435-24
🏷️ FDA NDC (as labeled)
55758-435-24
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
55758-435-24
Product NDC
55758-435
11-digit billing NDC
55758043524
RxCUI
307686
UNII
3G6A5W338E, 362O9ITL9D
Application #
M013
SPL Set ID
1e7a0c06-ad3c-b94f-e063-6394a90abab1
Established class (EPC)
Central Nervous System Stimulant; Methylxanthine
Physiologic effect
Central Nervous System Stimulation
Chemical class
Xanthines
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-07-30
Route
ORAL
Dosage form
TABLET
Substance
CAFFEINE; ACETAMINOPHEN
Why two NDCs?
The FDA registers this code as 55758-435-24 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55758-0435-24. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Drug family (ATC)
Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerPharmadel LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio67 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
DoloDent Toothache is an over-the-counter oral tablet containing acetaminophen and caffeine. Acetaminophen is commonly used to relieve pain and reduce fever, while caffeine is a central nervous system stimulant often added to pain relievers to enhance their effects. This product is marketed under FDA's OTC monograph rules for its category rather than as an individually approved application. It is intended for adults experiencing toothache discomfort.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Acetaminophen, Caffeine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeCapsule
ImprintA2
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 7T9FYH5QMK
A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescroscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tension Headache 500 mg/1; 65 mg 70000-0159-01 | Cardinal | 24 tablets | $0.064 | — | Availability likely | — |
| Excedrin Tension Headache 500 mg/1; 65 mg 00067-8139-01 | Haleon | 24 tablets | — | — | FDA listed | — |
| PANADOL Extra 500 mg/1; 65 mg 00135-0620-01 | Haleon | 24 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 00363-0572-31 | Walgreen | 80 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 00363-7213-10 | WALGREENS | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 11673-0839-01 | TARGET | 100 tablets | — | — | FDA listed | — |
| Tension Headache Aspirin-Free 500 mg/1; 65 mg 11822-0428-02 | Rite | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 49483-0373-01 | TIME | 100 tablets | — | — | FDA listed | — |
| DoloDent Toothache For adults 65 mg/1; 500 mgthis 55758-0435-24 | Pharmadel | 24 tablets | — | — | FDA listed | — |
| Tension Headache Aspirin Free 500 mg/1; 65 mg 59779-0824-06 | CVS | 200 tablets | — | — | FDA listed | — |
| DRX CHOICE Tension Headache 500 mg/1; 65 mg 68163-0506-15 | Raritan | 15 tablets | — | — | FDA listed | — |
| Sed-Max 500 mg/1; 65 mg 69197-0029-20 | Command | 20 tablets | — | — | FDA listed | — |
| Cafizetamol Forte 500 mg/1; 65 mg 69729-0147-40 | OPMX | 40 tablets | — | — | FDA listed | — |
| Migrafein FORTE 500 mg/1; 65 mg 69729-0148-40 | OPMX | 40 tablets | — | — | FDA listed | — |
| Neo-Lubrina Fuerte 500 mg/1; 65 mg 69729-0149-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Mejoral 500 mg/1; 65 mg 69729-0154-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| KORTRIBION Pain Reliever 500 mg/1; 65 mg 69729-0793-24 | OPMX | 12 tablets | — | — | FDA listed | — |
| Doloneuro-Tropas 500 mg/1; 65 mg 69729-0795-80 | OPMX | 4 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 69732-0007-01 | Hi-Tech | 100 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 72090-0004-02 | Pioneer | 200 tablets | — | — | FDA listed | — |
| Tension Headache Pain Relieving Aid 500 mg/1; 65 mg 79903-0373-01 | WAL-MART | 100 tablets | — | — | FDA listed | — |
| NOTTS - Tension Headache 500 mg/1; 65 mg 82706-0010-01 | VIVUNT | 24 tablets | — | — | FDA listed | — |
| Tension Headache Relief 500 mg/1; 65 mg 84324-0002-01 | NUVICARE | 100 tablets | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DoloDent Toothache For adults (this brand).
Top reported reactions
Age at onset
Reporter sex
Female · 100%
Serious outcomes
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55758-0435-24 You're viewing this | 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE | 2024-07-30 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55758-435-24, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55758-0435-24, written without dashes as 55758043524. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55758-0435-24, the first segment (55758) is the labeler code FDA assigned to Pharmadel LLC; the middle segment (0435) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses For the temporary relief of minor aches and pains due to: toothache headache and to reduce fever
⏱️ Dosage and Administration ▾
Directions do not take more than directed (see OVERDOSE WARNING) adults and children 12 years of age and older: take 2 tablets, every 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours children under 12 years of age: do not use
⚠️ Warnings ▾
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours , which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash.
If a skin reaction occurs, stop use and seek medical help right away. Caffeine: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine -containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to any of the ingredients in this product on children under 12 years of age Ask a doctor before use if you have liver disease Ask a doctor before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor or dentist if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information store between 68°-77°F (20°-25°C)
🧪 Active Ingredient ▾
Active ingredients and Purposes Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid
🧪 Inactive Ingredients ▾
Inactive ingredients croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid, water
🎯 Purpose ▾
Active ingredients Purposes Acetaminophen 500 mg................... Pain reliever/fever reducer Caffeine 65 mg................................. Pain reliever aid
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.