Over-the-counter drug · OTC MONOGRAPH DRUG
Dolex Fem NDC 55758-326
acetaminophen, caffeine, pyrilamine maleate · Acetaminophen 500 mg/1 + 2 more ingredients · Tablet, Coated · Oral · Pharmadel LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55758-326-25 | 5575803262555758032625 | 1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACKMarketed from Oct 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dolex Fem
- Generic name (nonproprietary)
- acetaminophen, caffeine, pyrilamine maleate
- Active ingredients
- Acetaminophen — 500 mg/1Caffeine — 60 mg/1Pyrilamine maleate — 15 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Pharmadel LLCNDC labeler code 55758
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 55758-326_4a169436-bb76-aceb-e063-6394a90a557fSPL ID 4a169436-bb76-aceb-e063-6394a90a557fSPL set ID b1cab10b-19f1-f5d5-e053-2995a90a4d5fRxCUI 1597298UNII 362O9ITL9D, 3G6A5W338E, R35D29L3ZA
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455758032625followed by a unit qualifier and the quantityPackage 55758-0326-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses For the temporary relief of these symptoms associated with menstrual periods cramps bloating water- weight gain headache backache Muscle aches fatigue
Excerpt only. Read the full label for complete information.
About NDC 55758-326
- What is NDC 55758-326?
- 55758-326 is the product NDC for Dolex Fem, Acetaminophen 500 mg/1 + 2 more ingredients tablet, coated, listed with the FDA by Pharmadel LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dolex Fem (Acetaminophen, Caffeine, Pyrilamine Maleate).
- What is the active ingredient?
- Acetaminophen, Caffeine, Pyrilamine maleate.
- Who is the labeler?
- Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dolex Fem?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 013
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-019 |
| Extra Strength Pain Releifacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1242 |
| Aspirin 81 mgaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | H E B | 37808-600 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1001 |
| Extra Strength Pain Relieveracetaminophen tablets 500 mg | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-0669 |
| Pain Relieveracetaminophen capsules 500mg (minis-red opaque) | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-6684 |
| Mommys Bliss Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-793 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | CVS Pharmacy | 59779-126 |
| Good Neighbor Pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-211 |
| Acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | A-S Medication Solutions | 50090-6059 |
| Members Mark Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sam's West Inc | 68196-606 |
| Mommys Bliss Infants Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-893 |
| Thompson Extra Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Thompson | 73408-174 |
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-089 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-222 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | P & L Development, LLC | 49580-0282 |
| Dye Free Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreens | 0363-0285 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0519 |
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