Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Comfort-Time NDC 49483-347
acetaminophen, caffeine, and pyrilamine maleate · Acetaminophen 500 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Time Cap Labs, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-347-24 | 4948303472449483034724 | 24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)Marketed from Dec 14, 2018 |
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)
- Comfort-Time
- Generic name (nonproprietary)
- acetaminophen, caffeine, and pyrilamine maleate
- Active ingredients
- Acetaminophen — 500 mg/1Caffeine — 60 mg/1Pyrilamine maleate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Time Cap Labs, IncNDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5SPL ID 7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5SPL set ID e94a26a2-36e5-4e1e-aea1-24e035c98043RxCUI 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
N449483034724followed by a unit qualifier and the quantityPackage 49483-0347-24. 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 breast tenderness fatigue muscle aches
Excerpt only. Read the full label for complete information.
About NDC 49483-347
- What is NDC 49483-347?
- 49483-347 is the product NDC for Comfort-Time, Acetaminophen 500 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Time Cap Labs, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Comfort-Time (Acetaminophen, Caffeine, and Pyrilamine Maleate).
- What is the active ingredient?
- Acetaminophen, Caffeine, Pyrilamine maleate.
- Who is the labeler?
- Time Cap Labs, Inc, NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Comfort-Time?
- 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 part343
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 |
|---|---|---|---|---|
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-011 |
| Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl | Acetaminophen 250 mg/10mL + 4 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-116 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-012 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-013 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-014 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | PuraCap Pharmaceutical LLC | 51013-320 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-121 |
| Doans Extra Strengthmagnesium salicylate | Magnesium salicylate 580 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 55741-224 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC. | 69842-390 |
| Chewable Acetaminophen Childrensacetaminophen | Acetaminophen 80 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-092 |
| Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Genomma Lab USA, Inc. | 50066-525 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Chain Drug Consortium,LLC | 68016-654 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc | 54738-111 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-541 |
| Aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-128 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-540 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-548 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-559 |
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